Urinary Incontinence, Stress, Urinary Incontinence, Urge
Conditions
Keywords
urinary incontinence, midurethral sling, Botulinum toxin A (Botox A ®)
Brief summary
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
Detailed description
Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial. The purpose of MUSA is to: * compare treatment with either Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI * characterize patient characteristics associated with treatment response The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory. Secondary outcomes include: • Urogenital Distress Inventory Stress and Irritative subscales Other outcomes include: * Urogenital Distress Inventory Obstructive subscale * Patient bladder diary metrics including numbers of daily incontinence episodes and voids and voiding frequency * Other patient reported outcomes/validated instruments and associated scales and subscales: EQ-5D, IIQ-LF, OABq-LF, OAB-SATq, PISQ-IR, PGI-I, PGI-S, PGSC, and SF-36 * Physical measures of effectiveness: Postvoid Residual Volume The study will continue with an additional 6 month observational period until 12 months post treatment. A supplemental study will characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A. Those results are not reported with this record.
Interventions
DRUGBotox® injection
Botulinum toxin A will be prepared by dissolving 100 units of botulinum toxin A into 10 ml of injectable saline. Indigo carmine or methylene blue 0.1 ml will be added to each syringe of botulinum toxin A. The treating physician will inject a total of 10 ml of the Botox A® into approximately 15 to 20 different detrusor muscle sites under direct visualization.
DEVICEMid-urethral sling
Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. Mini-sling and single-incision sling will not be allowed due to potential risk for higher failure rate.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Women and Infants Hospital of Rhode Island
Duke University
University of Pennsylvania
University of Pittsburgh
University of California, San Diego
Kaiser Permanente
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
RTI International
NICHD Pelvic Floor Disorders Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
At 6 months, the effect of treatment with Botox A or mid-urethral sling will be evaluated within a classic RCT model. The analysis will determine the effect of treatment on the primary outcome, change in Urogenital Distress Inventory (UDI) score at 6 months.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Reporting at least moderate bother from UUI item on UDI \* Do you experience urine leakage associated with a feeling of urgency? 2. Reporting at least moderate bother from SUI item on UDI \* Do you experience urine leakage related to physical activity, coughing, or sneezing? 3. Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months 4. Presence of UUI on bladder diary with \> 4 Urgency IE/3-day diary 5. Urinary symptoms \>3 months 6. Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician. 7. Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is 1. intolerant of oral overactive bladder medications, or 2. oral overactive bladder medications are contraindicated as determined by the treating provider. 8. Urodynamics within past 18 months 9. Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.
Exclusion criteria
1. Anterior or apical compartment prolapse at or beyond the hymen (\>0 on POPQ), regardless if patient is symptomatic \* Women with anterior or apical prolapse above the hymen (\<0) who do not report vaginal bulge symptoms will be eligible 2. Planned concomitant surgery for anterior vaginal wall or apical prolapse \> 0 \* Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment are eligible 3. Women undergoing hysterectomy for any indication will be excluded 4. Active pelvic organ malignancy 5. Age \<21 years 6. Pregnant or plans for future pregnancy in next 6 months, or within 12 months post-partum 7. Post-void residual \>150 cc on 2 occasions within the past 6 months, or current catheter use 8. Participation in other trial that may influence results of this study 9. Unevaluated hematuria 10. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for urinary incontinence 11. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth 12. Women on overactive bladder medication/therapy will be eligible after 3 week wash-out period 13. Non-ambulatory 14. History of serious adverse reaction to synthetic mesh 15. Not able to complete study assessments per clinician judgment, or not available for 6 month follow-up 16. Diagnosis of and/or history of bladder pain or chronic pelvic pain 17. Women who had intravesical Botox injection within the past 12 months 18. Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UDI-LF Total Score Change From Baseline | 3, 6, 9, and 12 Months | The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UDI-LF Stress Score Change From Baseline | 3, 6, 9, and 12 Months | The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| UDI-LF Irritative Score Change From Baseline | 3, 6, 9, and 12 Months | The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Frequency of Diurnal Voids Change From Baseline | 3, 6, and 12 Months | Based on data collected from participant-completed diaries, average daily frequency of diurnal voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline. |
| Average Daily Frequency of Nocturnal Voids Change From Baseline | 3, 6, and 12 Months | Based on data collected from participant-completed diaries, average daily frequency of nocturnal voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline. |
| Average Daily Frequency of All Voids Change From Baseline | 3, 6, and 12 Months | Based on data collected from participant-completed diaries, average daily frequency of all voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline. |
| Normalization of Voiding Frequency | 3, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, for participants with \>8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise |
| Improvement of 50% or More in Voiding Frequency Post Baseline | 3, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between the timepoint and baseline, No=Otherwise |
| Worsening Voiding Frequency Post Baseline | 3, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise |
| Change From Baseline EQ-5D Visual Analog Score | 0.5 Months (2 Weeks) and 3, 6, and 12 Months | EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline EQ-5D Index Score | 0.5 Months (2 Weeks) and 3, 6, and 12 Months | EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIQ-LF Physical Activity Score | 3, 6, 9, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIQ-LF Travel Score | 3, 6, 9, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIQ-LF Social/Relationships Score | 3, 6, 9, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIQ-LF Emotional Health Score | 3, 6, 9, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIQ-LF Total Score | 3, 6, 9, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Symptom Severity Score | 3, 6, 9, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Coping Score | 3, 6, 9, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Concern Score | 3, 6, 9, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Sleep Score | 3, 6, 9, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Social Score | 3, 6, 9, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF HRQL Total Score | 3, 6, 9, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| OAB-SATq-LF Satisfaction Score | 3, 6, 9, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction. |
| OAB-SATq-LF Side Effects Score | 3, 6, 9, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects. |
| OAB-SATq-LF Endorsement Score | 3, 6, 9, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement. |
| OAB-SATq-LF Convenience Score | 3, 6, 9, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience. |
| OAB-SAT-q Preference Indicator | 3, 6, 9, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary \[yes/no\] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments. |
| PGI-I Score Binary Improvement Indicator | 3, 6, 9, and 12 Months | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better). |
| PGI-S Score Binary Condition Severity Indicator | Baseline and 3, 6, 9, and 12 Months | The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2. |
| PGSC Score Binary Improvement Indicator | 3, 6, 9, and 12 Months | Patient GLobal Impression of Symptom Control(PGSC) is a patient-reported measure of perceived adequate symptom control, as assessed on a scale of 1 (disagree strongly) to 5 (agree strongly). Included here are participants who had adequate control as indicated by a rating of 5 (agree strongly) or 4 (agree). |
| Change From Baseline PISQ-IR NSA-PR Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR NSA-CS Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR NSA-GQA Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR NSA-CI Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SA-AO Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SA-PR Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SA-CS Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SA-GQR Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SA-CI Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SA-D Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SA Average Score | 3, 6, 9, and 12 months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline. |
| SF-36 Physical Functioning Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for physical function domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| SF-36 Role Physical Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for physical role limitations domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| SF-36 Bodily Pain Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for bodily pain domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| SF-36 General Health Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| SF-36 Vitality Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for vitality domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| SF-36 Social Functioning Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for social functioning domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| SF-36 Emotional Role Limitations Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for emotional role limitation domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| UDI-LF Obstructive Score Change From Baseline | 3, 6, 9, and 12 Months | The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| SF-36 Physical Composite Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The physical composite score is a normalized t-score which combines the all 8 domains with a mean of 50 and standard deviation of 10 (higher scores indicate greater physical function). A t-score below 50 is a good all-around cutoff for detecting physical condition (per the Ware manual). The outcome is calculated as the difference in score at 2 weeks and 3, 6, or 12 months and the score at baseline. |
| SF-36 Mental Composite Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The mental composite score is a normalized t-score which combines the all 8 domains with a mean of 50 and standard deviation of 10 (higher scores indicate greater mental health). A t-score below 52 is a well-documented cutoff for detecting depression (per the Ware manual). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Postvoid Residual Volume | Baseline, 3, 6, and 12 Months | Postvoid Residual Volume |
| SF-36 Mental Health Score | 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months | SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for social functioning domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 3, 6, and 12 Months | Based on data collected from participant-completed diaries, average daily frequency of combined mixed stress/urge and non-categorized incontinence epsiodes. The outcome variable is computed as the difference in number of episodes at 3, 6, and 12 months and the number of episodes at baseline. |
| Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 3, 6, and 12 Months | Based on data collected from participant-completed diaries, average daily frequency of all incontinence epsiodes. The outcome variable is computed as the difference in number of episodes at 3, 6, and 12 months and the number of episodes at baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botox A Up to 2 administrations of Botulinum Toxin A | 71 |
| Mid-Urethral Sling Mid-Urethral Sling for treatment of urinary incont | 66 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent only through 6 months | 1 | 1 |
| Overall Study | Insurance did not cover procedure | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 5 |
| Overall Study | Physician Decision | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | Mid-Urethral Sling | Total | Botox A |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 11.7 | 59 years STANDARD_DEVIATION 11.5 | 59.1 years STANDARD_DEVIATION 11.4 |
| Education 4-Year College Degree | 11 Participants | 32 Participants | 21 Participants |
| Education Associate College Degree | 13 Participants | 30 Participants | 17 Participants |
| Education Graduate Degree | 8 Participants | 16 Participants | 8 Participants |
| Education High School/GED | 29 Participants | 48 Participants | 19 Participants |
| Education Less than High School | 2 Participants | 5 Participants | 3 Participants |
| Education Unknown/Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Menopausal Status, Customized Not sure | 3 Participants | 11 Participants | 8 Participants |
| Menopausal Status, Customized Post-menopausal | 49 Participants | 105 Participants | 56 Participants |
| Menopausal Status, Customized Pre-menopausal | 14 Participants | 21 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 10 Participants | 20 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic/Latina | 6 Participants | 21 Participants | 15 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic/Not Latina | 59 Participants | 115 Participants | 56 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown/Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 54 Participants | 109 Participants | 55 Participants |
| Sex/Gender, Customized Female | 66 Participants | 137 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 69 |
| other Total, other adverse events | 40 / 71 | 41 / 69 |
| serious Total, serious adverse events | 3 / 71 | 8 / 69 |
Outcome results
Primary
UDI-LF Total Score Change From Baseline
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | UDI-LF Total Score Change From Baseline | 3.0 | -82.2 units on a scale |
| Botox A | UDI-LF Total Score Change From Baseline | 6.0 | -74.9 units on a scale |
| Botox A | UDI-LF Total Score Change From Baseline | 9.0 | -63.1 units on a scale |
| Botox A | UDI-LF Total Score Change From Baseline | 12.0 | -67.7 units on a scale |
| Mid-Urethral Sling | UDI-LF Total Score Change From Baseline | 12.0 | -89.2 units on a scale |
| Mid-Urethral Sling | UDI-LF Total Score Change From Baseline | 3.0 | -84.6 units on a scale |
| Mid-Urethral Sling | UDI-LF Total Score Change From Baseline | 9.0 | -85.6 units on a scale |
| Mid-Urethral Sling | UDI-LF Total Score Change From Baseline | 6.0 | -89.1 units on a scale |
Secondary
UDI-LF Irritative Score Change From Baseline
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | UDI-LF Irritative Score Change From Baseline | 3.0 | -40.8 units on a scale |
| Botox A | UDI-LF Irritative Score Change From Baseline | 6.0 | -35.8 units on a scale |
| Botox A | UDI-LF Irritative Score Change From Baseline | 9.0 | -32.7 units on a scale |
| Botox A | UDI-LF Irritative Score Change From Baseline | 12.0 | -31.6 units on a scale |
| Mid-Urethral Sling | UDI-LF Irritative Score Change From Baseline | 12.0 | -33 units on a scale |
| Mid-Urethral Sling | UDI-LF Irritative Score Change From Baseline | 3.0 | -28.1 units on a scale |
| Mid-Urethral Sling | UDI-LF Irritative Score Change From Baseline | 9.0 | -30.8 units on a scale |
| Mid-Urethral Sling | UDI-LF Irritative Score Change From Baseline | 6.0 | -30.6 units on a scale |
Secondary
UDI-LF Stress Score Change From Baseline
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | UDI-LF Stress Score Change From Baseline | 6.0 | -30.2 units on a scale |
| Botox A | UDI-LF Stress Score Change From Baseline | 9.0 | -20.2 units on a scale |
| Botox A | UDI-LF Stress Score Change From Baseline | 12.0 | -24.3 units on a scale |
| Botox A | UDI-LF Stress Score Change From Baseline | 3.0 | -27.9 units on a scale |
| Mid-Urethral Sling | UDI-LF Stress Score Change From Baseline | 3.0 | -46.4 units on a scale |
| Mid-Urethral Sling | UDI-LF Stress Score Change From Baseline | 6.0 | -45.1 units on a scale |
| Mid-Urethral Sling | UDI-LF Stress Score Change From Baseline | 12.0 | -44.4 units on a scale |
| Mid-Urethral Sling | UDI-LF Stress Score Change From Baseline | 9.0 | -42.3 units on a scale |
Other Pre-specified
Average Daily Frequency of All Incontinence Epsiodes Change From Baseline
Based on data collected from participant-completed diaries, average daily frequency of all incontinence epsiodes. The outcome variable is computed as the difference in number of episodes at 3, 6, and 12 months and the number of episodes at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 3.0 | -4 incontinence episodes/day |
| Botox A | Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 6.0 | -3.2 incontinence episodes/day |
| Botox A | Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 12.0 | -3.6 incontinence episodes/day |
| Mid-Urethral Sling | Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 3.0 | -3.9 incontinence episodes/day |
| Mid-Urethral Sling | Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 6.0 | -4.1 incontinence episodes/day |
| Mid-Urethral Sling | Average Daily Frequency of All Incontinence Epsiodes Change From Baseline | 12.0 | -4.5 incontinence episodes/day |
Other Pre-specified
Average Daily Frequency of All Voids Change From Baseline
Based on data collected from participant-completed diaries, average daily frequency of all voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Average Daily Frequency of All Voids Change From Baseline | 3.0 | -1.6 voids/day |
| Botox A | Average Daily Frequency of All Voids Change From Baseline | 6.0 | -1.1 voids/day |
| Botox A | Average Daily Frequency of All Voids Change From Baseline | 12.0 | -1.2 voids/day |
| Mid-Urethral Sling | Average Daily Frequency of All Voids Change From Baseline | 3.0 | -0.4 voids/day |
| Mid-Urethral Sling | Average Daily Frequency of All Voids Change From Baseline | 6.0 | -0.4 voids/day |
| Mid-Urethral Sling | Average Daily Frequency of All Voids Change From Baseline | 12.0 | -0.7 voids/day |
Other Pre-specified
Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline
Based on data collected from participant-completed diaries, average daily frequency of combined mixed stress/urge and non-categorized incontinence epsiodes. The outcome variable is computed as the difference in number of episodes at 3, 6, and 12 months and the number of episodes at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 3.0 | -0.4 incontinence episodes/day |
| Botox A | Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 6.0 | -0.2 incontinence episodes/day |
| Botox A | Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 12.0 | -0.2 incontinence episodes/day |
| Mid-Urethral Sling | Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 3.0 | -0.4 incontinence episodes/day |
| Mid-Urethral Sling | Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 6.0 | -0.7 incontinence episodes/day |
| Mid-Urethral Sling | Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline | 12.0 | -0.7 incontinence episodes/day |
Other Pre-specified
Average Daily Frequency of Diurnal Voids Change From Baseline
Based on data collected from participant-completed diaries, average daily frequency of diurnal voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Average Daily Frequency of Diurnal Voids Change From Baseline | 3.0 | -1.2 diurnal voids/day |
| Botox A | Average Daily Frequency of Diurnal Voids Change From Baseline | 6.0 | -0.8 diurnal voids/day |
| Botox A | Average Daily Frequency of Diurnal Voids Change From Baseline | 12.0 | -0.8 diurnal voids/day |
| Mid-Urethral Sling | Average Daily Frequency of Diurnal Voids Change From Baseline | 3.0 | 0 diurnal voids/day |
| Mid-Urethral Sling | Average Daily Frequency of Diurnal Voids Change From Baseline | 6.0 | -0.2 diurnal voids/day |
| Mid-Urethral Sling | Average Daily Frequency of Diurnal Voids Change From Baseline | 12.0 | -0.3 diurnal voids/day |
Other Pre-specified
Average Daily Frequency of Nocturnal Voids Change From Baseline
Based on data collected from participant-completed diaries, average daily frequency of nocturnal voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Average Daily Frequency of Nocturnal Voids Change From Baseline | 3.0 | -0.5 nocturnal voids/day |
| Botox A | Average Daily Frequency of Nocturnal Voids Change From Baseline | 6.0 | -0.3 nocturnal voids/day |
| Botox A | Average Daily Frequency of Nocturnal Voids Change From Baseline | 12.0 | -0.4 nocturnal voids/day |
| Mid-Urethral Sling | Average Daily Frequency of Nocturnal Voids Change From Baseline | 3.0 | -0.5 nocturnal voids/day |
| Mid-Urethral Sling | Average Daily Frequency of Nocturnal Voids Change From Baseline | 6.0 | -0.2 nocturnal voids/day |
| Mid-Urethral Sling | Average Daily Frequency of Nocturnal Voids Change From Baseline | 12.0 | -0.4 nocturnal voids/day |
Other Pre-specified
Change From Baseline EQ-5D Index Score
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline EQ-5D Index Score | 3.0 | 0 units on a scale |
| Botox A | Change From Baseline EQ-5D Index Score | 12.0 | 0 units on a scale |
| Botox A | Change From Baseline EQ-5D Index Score | 6.0 | 0 units on a scale |
| Botox A | Change From Baseline EQ-5D Index Score | 9.0 | 0 units on a scale |
| Botox A | Change From Baseline EQ-5D Index Score | 0.5 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Index Score | 12.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Index Score | 0.5 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Index Score | 3.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Index Score | 9.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Index Score | 6.0 | 0 units on a scale |
Other Pre-specified
Change From Baseline EQ-5D Visual Analog Score
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline EQ-5D Visual Analog Score | 3.0 | 2.2 units on a scale |
| Botox A | Change From Baseline EQ-5D Visual Analog Score | 9.0 | 1.4 units on a scale |
| Botox A | Change From Baseline EQ-5D Visual Analog Score | 6.0 | 1.5 units on a scale |
| Botox A | Change From Baseline EQ-5D Visual Analog Score | 12.0 | 1.6 units on a scale |
| Botox A | Change From Baseline EQ-5D Visual Analog Score | 0.5 | 3.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Visual Analog Score | 12.0 | 7.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Visual Analog Score | 0.5 | 9.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Visual Analog Score | 3.0 | 6.7 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Visual Analog Score | 6.0 | 7.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline EQ-5D Visual Analog Score | 9.0 | 6.9 units on a scale |
Other Pre-specified
Change From Baseline IIQ-LF Emotional Health Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline IIQ-LF Emotional Health Score | 9.0 | -12.5 units on a scale |
| Botox A | Change From Baseline IIQ-LF Emotional Health Score | 6.0 | -20.2 units on a scale |
| Botox A | Change From Baseline IIQ-LF Emotional Health Score | 12.0 | -17.5 units on a scale |
| Botox A | Change From Baseline IIQ-LF Emotional Health Score | 3.0 | -17.7 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Emotional Health Score | 6.0 | -21.5 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Emotional Health Score | 3.0 | -19.5 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Emotional Health Score | 12.0 | -26.8 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Emotional Health Score | 9.0 | -19.7 units on a scale |
Other Pre-specified
Change From Baseline IIQ-LF Physical Activity Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline IIQ-LF Physical Activity Score | 6.0 | -20.7 units on a scale |
| Botox A | Change From Baseline IIQ-LF Physical Activity Score | 3.0 | -19.5 units on a scale |
| Botox A | Change From Baseline IIQ-LF Physical Activity Score | 9.0 | -16.9 units on a scale |
| Botox A | Change From Baseline IIQ-LF Physical Activity Score | 12.0 | -18.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Physical Activity Score | 12.0 | -25.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Physical Activity Score | 9.0 | -21.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Physical Activity Score | 3.0 | -20.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Physical Activity Score | 6.0 | -21.1 units on a scale |
Other Pre-specified
Change From Baseline IIQ-LF Social/Relationships Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline IIQ-LF Social/Relationships Score | 3.0 | -15.7 units on a scale |
| Botox A | Change From Baseline IIQ-LF Social/Relationships Score | 6.0 | -16.9 units on a scale |
| Botox A | Change From Baseline IIQ-LF Social/Relationships Score | 9.0 | -10.3 units on a scale |
| Botox A | Change From Baseline IIQ-LF Social/Relationships Score | 12.0 | -15.7 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Social/Relationships Score | 12.0 | -22.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Social/Relationships Score | 3.0 | -18.9 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Social/Relationships Score | 9.0 | -19.9 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Social/Relationships Score | 6.0 | -20.3 units on a scale |
Other Pre-specified
Change From Baseline IIQ-LF Total Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline IIQ-LF Total Score | 3.0 | -72.9 units on a scale |
| Botox A | Change From Baseline IIQ-LF Total Score | 6.0 | -81.1 units on a scale |
| Botox A | Change From Baseline IIQ-LF Total Score | 9.0 | -54 units on a scale |
| Botox A | Change From Baseline IIQ-LF Total Score | 12.0 | -71 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Total Score | 12.0 | -102.5 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Total Score | 3.0 | -80.8 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Total Score | 9.0 | -86.6 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Total Score | 6.0 | -88.4 units on a scale |
Other Pre-specified
Change From Baseline IIQ-LF Travel Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline IIQ-LF Travel Score | 12.0 | -19.7 units on a scale |
| Botox A | Change From Baseline IIQ-LF Travel Score | 6.0 | -23.3 units on a scale |
| Botox A | Change From Baseline IIQ-LF Travel Score | 9.0 | -14.3 units on a scale |
| Botox A | Change From Baseline IIQ-LF Travel Score | 3.0 | -19.6 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Travel Score | 9.0 | -25.8 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Travel Score | 3.0 | -22.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Travel Score | 12.0 | -28.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline IIQ-LF Travel Score | 6.0 | -25.4 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Concern Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline OABq-LF Concern Score | 6.0 | 26.1 units on a scale |
| Botox A | Change From Baseline OABq-LF Concern Score | 9.0 | 16.7 units on a scale |
| Botox A | Change From Baseline OABq-LF Concern Score | 3.0 | 32.3 units on a scale |
| Botox A | Change From Baseline OABq-LF Concern Score | 12.0 | 24.5 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Concern Score | 12.0 | 35.6 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Concern Score | 6.0 | 31.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Concern Score | 3.0 | 29.6 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Concern Score | 9.0 | 28.2 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Coping Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline OABq-LF Coping Score | 9.0 | 18.8 units on a scale |
| Botox A | Change From Baseline OABq-LF Coping Score | 6.0 | 24.3 units on a scale |
| Botox A | Change From Baseline OABq-LF Coping Score | 12.0 | 24.7 units on a scale |
| Botox A | Change From Baseline OABq-LF Coping Score | 3.0 | 29.7 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Coping Score | 6.0 | 29.8 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Coping Score | 3.0 | 29.5 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Coping Score | 12.0 | 34.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Coping Score | 9.0 | 26.4 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF HRQL Total Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline OABq-LF HRQL Total Score | 3.0 | 26.4 units on a scale |
| Botox A | Change From Baseline OABq-LF HRQL Total Score | 6.0 | 21.8 units on a scale |
| Botox A | Change From Baseline OABq-LF HRQL Total Score | 9.0 | 14.8 units on a scale |
| Botox A | Change From Baseline OABq-LF HRQL Total Score | 12.0 | 20.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF HRQL Total Score | 12.0 | 29.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF HRQL Total Score | 3.0 | 25.9 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF HRQL Total Score | 9.0 | 23.9 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF HRQL Total Score | 6.0 | 25.9 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Sleep Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline OABq-LF Sleep Score | 9.0 | 15.6 units on a scale |
| Botox A | Change From Baseline OABq-LF Sleep Score | 6.0 | 21.6 units on a scale |
| Botox A | Change From Baseline OABq-LF Sleep Score | 12.0 | 16.8 units on a scale |
| Botox A | Change From Baseline OABq-LF Sleep Score | 3.0 | 23.8 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Sleep Score | 12.0 | 19.8 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Sleep Score | 6.0 | 18.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Sleep Score | 9.0 | 19 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Sleep Score | 3.0 | 20.7 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Social Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline OABq-LF Social Score | 3.0 | 15.1 units on a scale |
| Botox A | Change From Baseline OABq-LF Social Score | 6.0 | 11.8 units on a scale |
| Botox A | Change From Baseline OABq-LF Social Score | 9.0 | 4.8 units on a scale |
| Botox A | Change From Baseline OABq-LF Social Score | 12.0 | 11 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Social Score | 12.0 | 21 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Social Score | 3.0 | 20 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Social Score | 9.0 | 18.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Social Score | 6.0 | 19.6 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Symptom Severity Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline OABq-LF Symptom Severity Score | 3.0 | -41 units on a scale |
| Botox A | Change From Baseline OABq-LF Symptom Severity Score | 6.0 | -34.3 units on a scale |
| Botox A | Change From Baseline OABq-LF Symptom Severity Score | 9.0 | -26.7 units on a scale |
| Botox A | Change From Baseline OABq-LF Symptom Severity Score | 12.0 | -30.6 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Symptom Severity Score | 12.0 | -36.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Symptom Severity Score | 3.0 | -28.7 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Symptom Severity Score | 9.0 | -28.8 units on a scale |
| Mid-Urethral Sling | Change From Baseline OABq-LF Symptom Severity Score | 6.0 | -32 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSA-CI Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR NSA-CI Score | 3.0 | -0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-CI Score | 6.0 | -0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-CI Score | 9.0 | -0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-CI Score | 12.0 | -0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-CI Score | 12.0 | -0.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-CI Score | 3.0 | -0.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-CI Score | 9.0 | -0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-CI Score | 6.0 | -0.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSA-CS Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR NSA-CS Score | 3.0 | -0.2 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-CS Score | 6.0 | -0.2 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-CS Score | 9.0 | -0.2 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-CS Score | 12.0 | 0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-CS Score | 12.0 | -0.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-CS Score | 3.0 | -0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-CS Score | 9.0 | -0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-CS Score | 6.0 | 0 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSA-GQA Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR NSA-GQA Score | 3.0 | -0.1 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-GQA Score | 12.0 | -0.4 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-GQA Score | 6.0 | -0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-GQA Score | 9.0 | -0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-GQA Score | 12.0 | -0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-GQA Score | 3.0 | -0.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-GQA Score | 9.0 | -0.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-GQA Score | 6.0 | -0.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSA-PR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR NSA-PR Score | 3.0 | 0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-PR Score | 9.0 | 0.1 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-PR Score | 12.0 | 0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR NSA-PR Score | 6.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-PR Score | 12.0 | 0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-PR Score | 3.0 | 0.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-PR Score | 6.0 | 0.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR NSA-PR Score | 9.0 | 0.1 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-AO Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR SA-AO Score | 3.0 | 0 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-AO Score | 6.0 | 0 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-AO Score | 9.0 | -0.1 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-AO Score | 12.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-AO Score | 12.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-AO Score | 3.0 | -0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-AO Score | 9.0 | 0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-AO Score | 6.0 | 0.1 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA Average Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR SA Average Score | 3.0 | 0.2 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA Average Score | 6.0 | 0.1 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA Average Score | 9.0 | 0 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA Average Score | 12.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA Average Score | 12.0 | 0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA Average Score | 3.0 | 0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA Average Score | 9.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA Average Score | 6.0 | 0.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-CI Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR SA-CI Score | 12.0 | 0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-CI Score | 6.0 | 0.2 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-CI Score | 9.0 | 0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-CI Score | 3.0 | 0.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-CI Score | 12.0 | 0.9 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-CI Score | 3.0 | 0.6 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-CI Score | 9.0 | 0.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-CI Score | 6.0 | 0.8 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-CS Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR SA-CS Score | 3.0 | 0.5 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-CS Score | 6.0 | 0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-CS Score | 9.0 | 0.3 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-CS Score | 12.0 | 0.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-CS Score | 12.0 | 0.4 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-CS Score | 3.0 | 0.5 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-CS Score | 9.0 | 0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-CS Score | 6.0 | 0.6 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-D Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR SA-D Score | 3.0 | 0.1 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-D Score | 6.0 | 0 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-D Score | 9.0 | 0 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-D Score | 12.0 | -0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-D Score | 12.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-D Score | 3.0 | 0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-D Score | 9.0 | 0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-D Score | 6.0 | -0.1 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-GQR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR SA-GQR Score | 6.0 | 0 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-GQR Score | 9.0 | -0.1 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-GQR Score | 12.0 | -0.1 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-GQR Score | 3.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-GQR Score | 3.0 | 0.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-GQR Score | 6.0 | 0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-GQR Score | 12.0 | -0.2 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-GQR Score | 9.0 | -0.4 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SA-PR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Change From Baseline PISQ-IR SA-PR Score | 3.0 | 0 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-PR Score | 6.0 | 0 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-PR Score | 9.0 | -0.1 units on a scale |
| Botox A | Change From Baseline PISQ-IR SA-PR Score | 12.0 | -0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-PR Score | 12.0 | -0.1 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-PR Score | 3.0 | 0 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-PR Score | 9.0 | -0.3 units on a scale |
| Mid-Urethral Sling | Change From Baseline PISQ-IR SA-PR Score | 6.0 | 0.1 units on a scale |
Other Pre-specified
Improvement of 50% or More in Voiding Frequency Post Baseline
Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between the timepoint and baseline, No=Otherwise
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Botox A | Improvement of 50% or More in Voiding Frequency Post Baseline | 3.0 | No | 60 Participants |
| Botox A | Improvement of 50% or More in Voiding Frequency Post Baseline | 3.0 | Yes | 1 Participants |
| Botox A | Improvement of 50% or More in Voiding Frequency Post Baseline | 6.0 | No | 53 Participants |
| Botox A | Improvement of 50% or More in Voiding Frequency Post Baseline | 6.0 | Yes | 0 Participants |
| Botox A | Improvement of 50% or More in Voiding Frequency Post Baseline | 12.0 | No | 50 Participants |
| Botox A | Improvement of 50% or More in Voiding Frequency Post Baseline | 12.0 | Yes | 3 Participants |
| Mid-Urethral Sling | Improvement of 50% or More in Voiding Frequency Post Baseline | 12.0 | No | 54 Participants |
| Mid-Urethral Sling | Improvement of 50% or More in Voiding Frequency Post Baseline | 3.0 | No | 61 Participants |
| Mid-Urethral Sling | Improvement of 50% or More in Voiding Frequency Post Baseline | 6.0 | Yes | 1 Participants |
| Mid-Urethral Sling | Improvement of 50% or More in Voiding Frequency Post Baseline | 3.0 | Yes | 0 Participants |
| Mid-Urethral Sling | Improvement of 50% or More in Voiding Frequency Post Baseline | 12.0 | Yes | 2 Participants |
| Mid-Urethral Sling | Improvement of 50% or More in Voiding Frequency Post Baseline | 6.0 | No | 59 Participants |
Other Pre-specified
Normalization of Voiding Frequency
Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, for participants with \>8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Botox A | Normalization of Voiding Frequency | 3.0 | No | 17 Participants |
| Botox A | Normalization of Voiding Frequency | 3.0 | Yes | 23 Participants |
| Botox A | Normalization of Voiding Frequency | 6.0 | No | 17 Participants |
| Botox A | Normalization of Voiding Frequency | 6.0 | Yes | 18 Participants |
| Botox A | Normalization of Voiding Frequency | 12.0 | No | 13 Participants |
| Botox A | Normalization of Voiding Frequency | 12.0 | Yes | 24 Participants |
| Mid-Urethral Sling | Normalization of Voiding Frequency | 12.0 | No | 21 Participants |
| Mid-Urethral Sling | Normalization of Voiding Frequency | 3.0 | No | 24 Participants |
| Mid-Urethral Sling | Normalization of Voiding Frequency | 6.0 | Yes | 10 Participants |
| Mid-Urethral Sling | Normalization of Voiding Frequency | 3.0 | Yes | 13 Participants |
| Mid-Urethral Sling | Normalization of Voiding Frequency | 12.0 | Yes | 12 Participants |
| Mid-Urethral Sling | Normalization of Voiding Frequency | 6.0 | No | 25 Participants |
Other Pre-specified
OAB-SATq-LF Convenience Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | OAB-SATq-LF Convenience Score | 3.0 | 64.2 units on a scale |
| Botox A | OAB-SATq-LF Convenience Score | 6.0 | 66.5 units on a scale |
| Botox A | OAB-SATq-LF Convenience Score | 9.0 | 67.6 units on a scale |
| Botox A | OAB-SATq-LF Convenience Score | 12.0 | 65.6 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Convenience Score | 12.0 | 66.3 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Convenience Score | 3.0 | 64.1 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Convenience Score | 9.0 | 64.7 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Convenience Score | 6.0 | 66.8 units on a scale |
Other Pre-specified
OAB-SATq-LF Endorsement Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | OAB-SATq-LF Endorsement Score | 3.0 | 74.3 units on a scale |
| Botox A | OAB-SATq-LF Endorsement Score | 6.0 | 72 units on a scale |
| Botox A | OAB-SATq-LF Endorsement Score | 9.0 | 77.7 units on a scale |
| Botox A | OAB-SATq-LF Endorsement Score | 12.0 | 71.7 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Endorsement Score | 12.0 | 68.2 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Endorsement Score | 3.0 | 67.9 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Endorsement Score | 9.0 | 73.6 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Endorsement Score | 6.0 | 68.3 units on a scale |
Other Pre-specified
OAB-SATq-LF Satisfaction Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | OAB-SATq-LF Satisfaction Score | 3.0 | 65.7 units on a scale |
| Botox A | OAB-SATq-LF Satisfaction Score | 6.0 | 64.5 units on a scale |
| Botox A | OAB-SATq-LF Satisfaction Score | 9.0 | 64.4 units on a scale |
| Botox A | OAB-SATq-LF Satisfaction Score | 12.0 | 60.4 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Satisfaction Score | 12.0 | 56.3 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Satisfaction Score | 3.0 | 60.1 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Satisfaction Score | 9.0 | 57.5 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Satisfaction Score | 6.0 | 60.3 units on a scale |
Other Pre-specified
OAB-SATq-LF Side Effects Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | OAB-SATq-LF Side Effects Score | 3.0 | 91.9 units on a scale |
| Botox A | OAB-SATq-LF Side Effects Score | 6.0 | 89 units on a scale |
| Botox A | OAB-SATq-LF Side Effects Score | 9.0 | 90.2 units on a scale |
| Botox A | OAB-SATq-LF Side Effects Score | 12.0 | 91.8 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Side Effects Score | 12.0 | 88.5 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Side Effects Score | 3.0 | 93.5 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Side Effects Score | 9.0 | 86.3 units on a scale |
| Mid-Urethral Sling | OAB-SATq-LF Side Effects Score | 6.0 | 87.4 units on a scale |
Other Pre-specified
OAB-SAT-q Preference Indicator
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary \[yes/no\] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Botox A | OAB-SAT-q Preference Indicator | 3.0 | Yes | 47 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 12.0 | Unknown | 15 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 6.0 | No | 6 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 12.0 | No | 10 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 3.0 | No | 5 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 12.0 | Yes | 36 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 9.0 | No | 5 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 6.0 | Unknown | 17 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 6.0 | Yes | 41 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 3.0 | Unknown | 16 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 9.0 | Unknown | 17 Participants |
| Botox A | OAB-SAT-q Preference Indicator | 9.0 | Yes | 33 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 9.0 | Unknown | 15 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 3.0 | No | 5 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 3.0 | Yes | 35 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 6.0 | Unknown | 21 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 6.0 | No | 8 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 9.0 | No | 5 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 9.0 | Yes | 36 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 12.0 | Unknown | 19 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 12.0 | No | 7 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 12.0 | Yes | 34 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 6.0 | Yes | 36 Participants |
| Mid-Urethral Sling | OAB-SAT-q Preference Indicator | 3.0 | Unknown | 24 Participants |
Other Pre-specified
PGI-I Score Binary Improvement Indicator
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Botox A | PGI-I Score Binary Improvement Indicator | 3.0 | Yes | 40 Participants |
| Botox A | PGI-I Score Binary Improvement Indicator | 9.0 | Yes | 34 Participants |
| Botox A | PGI-I Score Binary Improvement Indicator | 6.0 | Yes | 39 Participants |
| Botox A | PGI-I Score Binary Improvement Indicator | 12.0 | No | 35 Participants |
| Botox A | PGI-I Score Binary Improvement Indicator | 6.0 | No | 25 Participants |
| Botox A | PGI-I Score Binary Improvement Indicator | 12.0 | Yes | 26 Participants |
| Botox A | PGI-I Score Binary Improvement Indicator | 9.0 | No | 22 Participants |
| Botox A | PGI-I Score Binary Improvement Indicator | 3.0 | No | 28 Participants |
| Mid-Urethral Sling | PGI-I Score Binary Improvement Indicator | 3.0 | Yes | 34 Participants |
| Mid-Urethral Sling | PGI-I Score Binary Improvement Indicator | 3.0 | No | 30 Participants |
| Mid-Urethral Sling | PGI-I Score Binary Improvement Indicator | 6.0 | No | 33 Participants |
| Mid-Urethral Sling | PGI-I Score Binary Improvement Indicator | 6.0 | Yes | 32 Participants |
| Mid-Urethral Sling | PGI-I Score Binary Improvement Indicator | 9.0 | No | 25 Participants |
| Mid-Urethral Sling | PGI-I Score Binary Improvement Indicator | 9.0 | Yes | 31 Participants |
| Mid-Urethral Sling | PGI-I Score Binary Improvement Indicator | 12.0 | No | 31 Participants |
| Mid-Urethral Sling | PGI-I Score Binary Improvement Indicator | 12.0 | Yes | 29 Participants |
Other Pre-specified
PGI-S Score Binary Condition Severity Indicator
The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2.
Time frame: Baseline and 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Botox A | PGI-S Score Binary Condition Severity Indicator | Baseline | Yes | 13 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | 9.0 | No | 27 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | 3.0 | Yes | 39 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | 9.0 | Yes | 29 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | 3.0 | No | 29 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | 12.0 | No | 28 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | 6.0 | No | 29 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | 12.0 | Yes | 33 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | 6.0 | Yes | 35 Participants |
| Botox A | PGI-S Score Binary Condition Severity Indicator | Baseline | No | 57 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | 6.0 | No | 29 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | Baseline | No | 53 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | Baseline | Yes | 10 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | 3.0 | No | 30 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | 3.0 | Yes | 34 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | 6.0 | Yes | 36 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | 9.0 | No | 24 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | 9.0 | Yes | 32 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | 12.0 | No | 24 Participants |
| Mid-Urethral Sling | PGI-S Score Binary Condition Severity Indicator | 12.0 | Yes | 36 Participants |
Other Pre-specified
PGSC Score Binary Improvement Indicator
Patient GLobal Impression of Symptom Control(PGSC) is a patient-reported measure of perceived adequate symptom control, as assessed on a scale of 1 (disagree strongly) to 5 (agree strongly). Included here are participants who had adequate control as indicated by a rating of 5 (agree strongly) or 4 (agree).
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Botox A | PGSC Score Binary Improvement Indicator | 3.0 | No | 32 Participants |
| Botox A | PGSC Score Binary Improvement Indicator | 3.0 | Yes | 36 Participants |
| Botox A | PGSC Score Binary Improvement Indicator | 6.0 | No | 30 Participants |
| Botox A | PGSC Score Binary Improvement Indicator | 6.0 | Yes | 34 Participants |
| Botox A | PGSC Score Binary Improvement Indicator | 9.0 | No | 28 Participants |
| Botox A | PGSC Score Binary Improvement Indicator | 9.0 | Yes | 28 Participants |
| Botox A | PGSC Score Binary Improvement Indicator | 12.0 | No | 33 Participants |
| Botox A | PGSC Score Binary Improvement Indicator | 12.0 | Yes | 29 Participants |
| Mid-Urethral Sling | PGSC Score Binary Improvement Indicator | 12.0 | Yes | 36 Participants |
| Mid-Urethral Sling | PGSC Score Binary Improvement Indicator | 3.0 | No | 28 Participants |
| Mid-Urethral Sling | PGSC Score Binary Improvement Indicator | 9.0 | No | 27 Participants |
| Mid-Urethral Sling | PGSC Score Binary Improvement Indicator | 3.0 | Yes | 36 Participants |
| Mid-Urethral Sling | PGSC Score Binary Improvement Indicator | 12.0 | No | 24 Participants |
| Mid-Urethral Sling | PGSC Score Binary Improvement Indicator | 6.0 | No | 33 Participants |
| Mid-Urethral Sling | PGSC Score Binary Improvement Indicator | 9.0 | Yes | 29 Participants |
| Mid-Urethral Sling | PGSC Score Binary Improvement Indicator | 6.0 | Yes | 32 Participants |
Other Pre-specified
Postvoid Residual Volume
Postvoid Residual Volume
Time frame: Baseline, 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | Postvoid Residual Volume | 0.5 | 49.4 mL |
| Botox A | Postvoid Residual Volume | 6.0 | 31.7 mL |
| Botox A | Postvoid Residual Volume | 3.0 | 39.4 mL |
| Botox A | Postvoid Residual Volume | Baseline | 20.4 mL |
| Mid-Urethral Sling | Postvoid Residual Volume | 3.0 | 27.2 mL |
| Mid-Urethral Sling | Postvoid Residual Volume | 0.5 | 26.5 mL |
| Mid-Urethral Sling | Postvoid Residual Volume | Baseline | 22.7 mL |
| Mid-Urethral Sling | Postvoid Residual Volume | 6.0 | 37.1 mL |
Other Pre-specified
SF-36 Bodily Pain Score
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for bodily pain domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Bodily Pain Score | 3.0 | 5.1 units on a scale |
| Botox A | SF-36 Bodily Pain Score | 9.0 | -1.6 units on a scale |
| Botox A | SF-36 Bodily Pain Score | 0.5 | 2.6 units on a scale |
| Botox A | SF-36 Bodily Pain Score | 12.0 | -0.8 units on a scale |
| Botox A | SF-36 Bodily Pain Score | 6.0 | -0.4 units on a scale |
| Mid-Urethral Sling | SF-36 Bodily Pain Score | 12.0 | 6.4 units on a scale |
| Mid-Urethral Sling | SF-36 Bodily Pain Score | 3.0 | 0.6 units on a scale |
| Mid-Urethral Sling | SF-36 Bodily Pain Score | 6.0 | 0.8 units on a scale |
| Mid-Urethral Sling | SF-36 Bodily Pain Score | 9.0 | 4.2 units on a scale |
| Mid-Urethral Sling | SF-36 Bodily Pain Score | 0.5 | 2.4 units on a scale |
Other Pre-specified
SF-36 Emotional Role Limitations Score
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for emotional role limitation domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Emotional Role Limitations Score | 3.0 | 19.9 units on a scale |
| Botox A | SF-36 Emotional Role Limitations Score | 9.0 | 13 units on a scale |
| Botox A | SF-36 Emotional Role Limitations Score | 6.0 | 12.7 units on a scale |
| Botox A | SF-36 Emotional Role Limitations Score | 12.0 | 9.8 units on a scale |
| Botox A | SF-36 Emotional Role Limitations Score | 0.5 | 16.4 units on a scale |
| Mid-Urethral Sling | SF-36 Emotional Role Limitations Score | 12.0 | 13.3 units on a scale |
| Mid-Urethral Sling | SF-36 Emotional Role Limitations Score | 0.5 | 12.2 units on a scale |
| Mid-Urethral Sling | SF-36 Emotional Role Limitations Score | 3.0 | 14.6 units on a scale |
| Mid-Urethral Sling | SF-36 Emotional Role Limitations Score | 6.0 | 12.5 units on a scale |
| Mid-Urethral Sling | SF-36 Emotional Role Limitations Score | 9.0 | 7.4 units on a scale |
Other Pre-specified
SF-36 General Health Score
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 General Health Score | 3.0 | 2.4 units on a scale |
| Botox A | SF-36 General Health Score | 9.0 | -1.6 units on a scale |
| Botox A | SF-36 General Health Score | 6.0 | 2.6 units on a scale |
| Botox A | SF-36 General Health Score | 12.0 | -1.1 units on a scale |
| Botox A | SF-36 General Health Score | 0.5 | 5.2 units on a scale |
| Mid-Urethral Sling | SF-36 General Health Score | 12.0 | -0.3 units on a scale |
| Mid-Urethral Sling | SF-36 General Health Score | 0.5 | 2.5 units on a scale |
| Mid-Urethral Sling | SF-36 General Health Score | 3.0 | -1.7 units on a scale |
| Mid-Urethral Sling | SF-36 General Health Score | 6.0 | -0.6 units on a scale |
| Mid-Urethral Sling | SF-36 General Health Score | 9.0 | -2.2 units on a scale |
Other Pre-specified
SF-36 Mental Composite Score
SF-36 is a standardized survey evaluating 8 domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The mental composite score is a normalized t-score which combines the all 8 domains with a mean of 50 and standard deviation of 10 (higher scores indicate greater mental health). A t-score below 52 is a well-documented cutoff for detecting depression (per the Ware manual). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Mental Composite Score | 3.0 | 2.7 T-score |
| Botox A | SF-36 Mental Composite Score | 9.0 | 0.6 T-score |
| Botox A | SF-36 Mental Composite Score | 6.0 | 1.6 T-score |
| Botox A | SF-36 Mental Composite Score | 12.0 | 0.9 T-score |
| Botox A | SF-36 Mental Composite Score | 0.5 | 2.2 T-score |
| Mid-Urethral Sling | SF-36 Mental Composite Score | 12.0 | 1.2 T-score |
| Mid-Urethral Sling | SF-36 Mental Composite Score | 0.5 | 3.5 T-score |
| Mid-Urethral Sling | SF-36 Mental Composite Score | 3.0 | 1.9 T-score |
| Mid-Urethral Sling | SF-36 Mental Composite Score | 6.0 | 1.2 T-score |
| Mid-Urethral Sling | SF-36 Mental Composite Score | 9.0 | 1 T-score |
Other Pre-specified
SF-36 Mental Health Score
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for social functioning domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Mental Health Score | 3.0 | 0.8 units on a scale |
| Botox A | SF-36 Mental Health Score | 9.0 | -2.4 units on a scale |
| Botox A | SF-36 Mental Health Score | 6.0 | -2 units on a scale |
| Botox A | SF-36 Mental Health Score | 12.0 | -0.7 units on a scale |
| Botox A | SF-36 Mental Health Score | 0.5 | 0.2 units on a scale |
| Mid-Urethral Sling | SF-36 Mental Health Score | 12.0 | 1.3 units on a scale |
| Mid-Urethral Sling | SF-36 Mental Health Score | 0.5 | 5 units on a scale |
| Mid-Urethral Sling | SF-36 Mental Health Score | 3.0 | 1.8 units on a scale |
| Mid-Urethral Sling | SF-36 Mental Health Score | 6.0 | 1 units on a scale |
| Mid-Urethral Sling | SF-36 Mental Health Score | 9.0 | 0.6 units on a scale |
Other Pre-specified
SF-36 Physical Composite Score
SF-36 is a standardized survey evaluating 8 domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The physical composite score is a normalized t-score which combines the all 8 domains with a mean of 50 and standard deviation of 10 (higher scores indicate greater physical function). A t-score below 50 is a good all-around cutoff for detecting physical condition (per the Ware manual). The outcome is calculated as the difference in score at 2 weeks and 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Physical Composite Score | 3.0 | 3.1 T-score |
| Botox A | SF-36 Physical Composite Score | 9.0 | 1.1 T-score |
| Botox A | SF-36 Physical Composite Score | 6.0 | 3 T-score |
| Botox A | SF-36 Physical Composite Score | 12.0 | 2 T-score |
| Botox A | SF-36 Physical Composite Score | 0.5 | 3.9 T-score |
| Mid-Urethral Sling | SF-36 Physical Composite Score | 12.0 | 2.8 T-score |
| Mid-Urethral Sling | SF-36 Physical Composite Score | 0.5 | 1.5 T-score |
| Mid-Urethral Sling | SF-36 Physical Composite Score | 3.0 | 2.6 T-score |
| Mid-Urethral Sling | SF-36 Physical Composite Score | 6.0 | 3.1 T-score |
| Mid-Urethral Sling | SF-36 Physical Composite Score | 9.0 | 2.2 T-score |
Other Pre-specified
SF-36 Physical Functioning Score
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for physical function domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Physical Functioning Score | 0.5 | 12.9 units on a scale |
| Botox A | SF-36 Physical Functioning Score | 3.0 | 10.9 units on a scale |
| Botox A | SF-36 Physical Functioning Score | 6.0 | 10.5 units on a scale |
| Botox A | SF-36 Physical Functioning Score | 9.0 | 8.9 units on a scale |
| Botox A | SF-36 Physical Functioning Score | 12.0 | 10 units on a scale |
| Mid-Urethral Sling | SF-36 Physical Functioning Score | 12.0 | 13.3 units on a scale |
| Mid-Urethral Sling | SF-36 Physical Functioning Score | 9.0 | 9.7 units on a scale |
| Mid-Urethral Sling | SF-36 Physical Functioning Score | 3.0 | 13.9 units on a scale |
| Mid-Urethral Sling | SF-36 Physical Functioning Score | 0.5 | 12.2 units on a scale |
| Mid-Urethral Sling | SF-36 Physical Functioning Score | 6.0 | 14 units on a scale |
Other Pre-specified
SF-36 Role Physical Score
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for physical role limitations domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Role Physical Score | 3.0 | 12.5 units on a scale |
| Botox A | SF-36 Role Physical Score | 9.0 | 3.6 units on a scale |
| Botox A | SF-36 Role Physical Score | 6.0 | 12.3 units on a scale |
| Botox A | SF-36 Role Physical Score | 12.0 | 8.6 units on a scale |
| Botox A | SF-36 Role Physical Score | 0.5 | 14.1 units on a scale |
| Mid-Urethral Sling | SF-36 Role Physical Score | 12.0 | 4.9 units on a scale |
| Mid-Urethral Sling | SF-36 Role Physical Score | 0.5 | -1.2 units on a scale |
| Mid-Urethral Sling | SF-36 Role Physical Score | 3.0 | 11.3 units on a scale |
| Mid-Urethral Sling | SF-36 Role Physical Score | 6.0 | 12.1 units on a scale |
| Mid-Urethral Sling | SF-36 Role Physical Score | 9.0 | 7.7 units on a scale |
Other Pre-specified
SF-36 Social Functioning Score
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for social functioning domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Social Functioning Score | 3.0 | 11 units on a scale |
| Botox A | SF-36 Social Functioning Score | 9.0 | 4.5 units on a scale |
| Botox A | SF-36 Social Functioning Score | 6.0 | 11.5 units on a scale |
| Botox A | SF-36 Social Functioning Score | 12.0 | 6.4 units on a scale |
| Botox A | SF-36 Social Functioning Score | 0.5 | 10.9 units on a scale |
| Mid-Urethral Sling | SF-36 Social Functioning Score | 12.0 | 7.1 units on a scale |
| Mid-Urethral Sling | SF-36 Social Functioning Score | 0.5 | 9.1 units on a scale |
| Mid-Urethral Sling | SF-36 Social Functioning Score | 3.0 | 5.7 units on a scale |
| Mid-Urethral Sling | SF-36 Social Functioning Score | 6.0 | 6.6 units on a scale |
| Mid-Urethral Sling | SF-36 Social Functioning Score | 9.0 | 12.3 units on a scale |
Other Pre-specified
SF-36 Vitality Score
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for vitality domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | SF-36 Vitality Score | 3.0 | 3.5 units on a scale |
| Botox A | SF-36 Vitality Score | 9.0 | -0.8 units on a scale |
| Botox A | SF-36 Vitality Score | 6.0 | 4.7 units on a scale |
| Botox A | SF-36 Vitality Score | 12.0 | 2.7 units on a scale |
| Botox A | SF-36 Vitality Score | 0.5 | 6.1 units on a scale |
| Mid-Urethral Sling | SF-36 Vitality Score | 12.0 | 0.4 units on a scale |
| Mid-Urethral Sling | SF-36 Vitality Score | 0.5 | 6.5 units on a scale |
| Mid-Urethral Sling | SF-36 Vitality Score | 3.0 | 5.3 units on a scale |
| Mid-Urethral Sling | SF-36 Vitality Score | 6.0 | 3.4 units on a scale |
| Mid-Urethral Sling | SF-36 Vitality Score | 9.0 | -1.3 units on a scale |
Other Pre-specified
UDI-LF Obstructive Score Change From Baseline
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Botox A | UDI-LF Obstructive Score Change From Baseline | 6.0 | -8.9 units on a scale |
| Botox A | UDI-LF Obstructive Score Change From Baseline | 12.0 | -11.8 units on a scale |
| Botox A | UDI-LF Obstructive Score Change From Baseline | 9.0 | -10.2 units on a scale |
| Botox A | UDI-LF Obstructive Score Change From Baseline | 3.0 | -13.5 units on a scale |
| Mid-Urethral Sling | UDI-LF Obstructive Score Change From Baseline | 3.0 | -10.1 units on a scale |
| Mid-Urethral Sling | UDI-LF Obstructive Score Change From Baseline | 6.0 | -13.4 units on a scale |
| Mid-Urethral Sling | UDI-LF Obstructive Score Change From Baseline | 9.0 | -12.6 units on a scale |
| Mid-Urethral Sling | UDI-LF Obstructive Score Change From Baseline | 12.0 | -11.7 units on a scale |
Other Pre-specified
Worsening Voiding Frequency Post Baseline
Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Botox A | Worsening Voiding Frequency Post Baseline | 3.0 | No | 49 Participants |
| Botox A | Worsening Voiding Frequency Post Baseline | 3.0 | Yes | 12 Participants |
| Botox A | Worsening Voiding Frequency Post Baseline | 6.0 | No | 36 Participants |
| Botox A | Worsening Voiding Frequency Post Baseline | 6.0 | Yes | 17 Participants |
| Botox A | Worsening Voiding Frequency Post Baseline | 12.0 | No | 37 Participants |
| Botox A | Worsening Voiding Frequency Post Baseline | 12.0 | Yes | 16 Participants |
| Mid-Urethral Sling | Worsening Voiding Frequency Post Baseline | 12.0 | No | 34 Participants |
| Mid-Urethral Sling | Worsening Voiding Frequency Post Baseline | 3.0 | No | 39 Participants |
| Mid-Urethral Sling | Worsening Voiding Frequency Post Baseline | 6.0 | Yes | 28 Participants |
| Mid-Urethral Sling | Worsening Voiding Frequency Post Baseline | 3.0 | Yes | 22 Participants |
| Mid-Urethral Sling | Worsening Voiding Frequency Post Baseline | 12.0 | Yes | 22 Participants |
| Mid-Urethral Sling | Worsening Voiding Frequency Post Baseline | 6.0 | No | 32 Participants |