Urinary Bladder, Overactive
Conditions
Keywords
Overactive Bladder
Brief summary
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
Detailed description
Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group. The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment. Primary efficacy will be based on OAB-q symptom bother score.
Interventions
DRUGPlacebo
Oral Administration
DRUGSolifenacin Succinate
Oral Administration
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty * History of OAB symptoms for ≥ 3 months * An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary * Subjects are bothered by symptoms as reflected by PPBC ≥3
Exclusion criteria
* Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention * Recurrent urinary tract infection (UTI) of \> 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2) * Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator * History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator * History of diagnosed gastrointestinal obstruction disease * Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years * Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Baseline and 12 Weeks | The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment - Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Baseline, Week 4, Week 8 and Week 12 | The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated as Actual Data for each time point - Baseline. |
| Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) | Baseline and 12 Weeks | The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems Improvement is defined by any reduction in PPBC score. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline |
| Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Baseline and 12 Weeks | The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy. |
| Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Baseline, Week 4, Week 8 and Week 12 | The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated End of Treatment (EOT) for each sub-domain - Baseline. |
| Change From Baseline in Work Productivity Assessment Index (WPAI) | Baseline and 12 Weeks | The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change from baseline is based on the ANCOVA model after adjusting baseline value & center. |
| Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Baseline, Week 4, Week 8 and Week 12 | The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. Change is calculated as Actual Data for each timepoint - Baseline. |
| Change From Baseline in the MCUI Behavior Therapy Stratified | Baseline and 12 Weeks | MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline |
| Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Baseline and 12 Weeks | ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline. |
| Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Baseline and 12 Weeks | ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline. |
| Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) | Baseline and 12 Weeks | The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely). Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study. Change is calculated as EOT - Baseline |
| Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Baseline and 12 Weeks | The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids. Change from baseline with a lower score indicates an improvement. End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table. Change is calculated as EOT - Baseline |
| Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | Baseline and 12 Weeks | MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching placebo tablet taken once daily | 382 |
| Solifenacin Succinate 5mg or 10mg tablet taken once daily | 386 |
| Total | 768 |
Baseline characteristics
| Characteristic | Placebo | Solifenacin Succinate | Total |
|---|---|---|---|
| Age Continuous | 59.4 years STANDARD_DEVIATION 12.36 | 59.4 years STANDARD_DEVIATION 13.44 | 59.4 years STANDARD_DEVIATION 12.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 participants | 3 participants | 6 participants |
| Race/Ethnicity, Customized Asian | 9 participants | 7 participants | 16 participants |
| Race/Ethnicity, Customized Black or African American | 30 participants | 24 participants | 54 participants |
| Race/Ethnicity, Customized Native Hawaiian-Other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 7 participants | 4 participants | 11 participants |
| Race/Ethnicity, Customized White | 333 participants | 347 participants | 680 participants |
| Sex: Female, Male Female | 321 Participants | 311 Participants | 632 Participants |
| Sex: Female, Male Male | 61 Participants | 75 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 382 | 84 / 386 |
| serious Total, serious adverse events | 6 / 382 | 3 / 386 |
Outcome results
Primary
Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment - Baseline.
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants per arm is consistent for all categories / rows of the data table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Baseline | 57.9 OAB-q Score | Standard Deviation 18.18 |
| Placebo | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | End of Treatment | 37.5 OAB-q Score | Standard Deviation 22.54 |
| Placebo | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Change at End of Treatment | -20.4 OAB-q Score | Standard Deviation 21.72 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Baseline | 58.2 OAB-q Score | Standard Deviation 18.75 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | End of Treatment | 28.3 OAB-q Score | Standard Deviation 20.36 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Change at End of Treatment | -29.9 OAB-q Score | Standard Deviation 22.64 |
Comparison: Statistical Analysis applies to 'Change at End of Treatment'.p-value: <0.000195% CI: [6.6, 12.2]ANCOVA
Secondary
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.
ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline.
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set(FAS): all randomized female patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Symptom- Baseline (N=302; 300) | 4.9 ICIQ-FLUTSsex | Standard Deviation 3.69 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Symptom- EOT (N=297; 291) | 3.9 ICIQ-FLUTSsex | Standard Deviation 3.46 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Symptom- Change at EOT (N=288; 288) | -0.9 ICIQ-FLUTSsex | Standard Deviation 3.53 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Bother- Baseline (N=281; 282) | 9.0 ICIQ-FLUTSsex | Standard Deviation 10.77 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Bother- EOT (N=263; 262) | 6.1 ICIQ-FLUTSsex | Standard Deviation 8.52 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Bother- Change at EOT (N=245; 249) | -3.1 ICIQ-FLUTSsex | Standard Deviation 8.11 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Bother- EOT (N=263; 262) | 6.6 ICIQ-FLUTSsex | Standard Deviation 9.43 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Symptom- Baseline (N=302; 300) | 5.2 ICIQ-FLUTSsex | Standard Deviation 3.63 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Bother- Baseline (N=281; 282) | 10.0 ICIQ-FLUTSsex | Standard Deviation 11.47 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Symptom- EOT (N=297; 291) | 3.8 ICIQ-FLUTSsex | Standard Deviation 3.55 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Bother- Change at EOT (N=245; 249) | -3.6 ICIQ-FLUTSsex | Standard Deviation 9.04 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores. | Symptom- Change at EOT (N=288; 288) | -1.3 ICIQ-FLUTSsex | Standard Deviation 3.75 |
Secondary
Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.
ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline.
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set(FAS): all randomized male patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Symptom- Baseline (N=59; 71) | 3.6 ICIQ-MLUTSsex | Standard Deviation 2.81 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Symptom- EOT (N=55; 68) | 3.2 ICIQ-MLUTSsex | Standard Deviation 2.71 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Symptom- Change at EOT (N=54; 68) | -0.1 ICIQ-MLUTSsex | Standard Deviation 1.57 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Bother- Baseline (N=59; 71) | 12.1 ICIQ-MLUTSsex | Standard Deviation 11.47 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Bother- EOT (N=51; 67) | 10.3 ICIQ-MLUTSsex | Standard Deviation 10.53 |
| Placebo | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Bother- Change at EOT (N=50; 67) | -1.6 ICIQ-MLUTSsex | Standard Deviation 8.24 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Bother- EOT (N=51; 67) | 11.4 ICIQ-MLUTSsex | Standard Deviation 11.17 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Symptom- Baseline (N=59; 71) | 3.5 ICIQ-MLUTSsex | Standard Deviation 3.01 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Bother- Baseline (N=59; 71) | 11.8 ICIQ-MLUTSsex | Standard Deviation 11.21 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Symptom- EOT (N=55; 68) | 3.7 ICIQ-MLUTSsex | Standard Deviation 3 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Bother- Change at EOT (N=50; 67) | -0.6 ICIQ-MLUTSsex | Standard Deviation 9.32 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Symptom- Change at EOT (N=54; 68) | 0.1 ICIQ-MLUTSsex | Standard Deviation 1.87 |
Secondary
Change From Baseline in the MCUI Behavior Therapy Stratified
MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication \& had an assessment in OAB-q at both baseline \& at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with fluid management- EOT (N=355; 366) | 15.1 Number of Days | Standard Deviation 28.76 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/pelvic flr exercises-Change atEOT(344; 349) | 3.4 Number of Days | Standard Deviation 50.96 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with timed voiding- EOT (N=356; 360) | 10.3 Number of Days | Standard Deviation 27.07 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with biofeedback- Baseline (N=359; 360) | 0.4 Number of Days | Standard Deviation 5.32 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with fluid management-Change at EOT(349; 360) | -6.3 Number of Days | Standard Deviation 42.36 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with biofeedback- EOT (N=352; 358) | 0.0 Number of Days | Standard Deviation 0.53 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with fluid management-Baseline(N=368; 369) | 21.3 Number of Days | Standard Deviation 40.07 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with biofeedback- Change at EOT (N=338; 343) | -0.4 Number of Days | Standard Deviation 5.18 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ pelvic floor exercises-Baseline(364; 366) | 8.5 Number of Days | Standard Deviation 22.17 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ electrical stimulation-Baseline (358; 362) | 0.0 Number of Days | Standard Deviation 0.63 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with timed voiding-Change at EOT(N=347; 350) | -4.0 Number of Days | Standard Deviation 37.38 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ electrical stimulation- EOT (N=352; 358) | 0.0 Number of Days | Standard Deviation 0.43 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ pelvic floor exercises- EOT (N=352; 358) | 12.1 Number of Days | Standard Deviation 56.94 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ elec stimulation-Change at EOT(N=337; 345) | 0.0 Number of Days | Standard Deviation 0.79 |
| Placebo | Change From Baseline in the MCUI Behavior Therapy Stratified | days with timed voiding- Baseline (N=364; 365) | 14.8 Number of Days | Standard Deviation 37.33 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ elec stimulation-Change at EOT(N=337; 345) | 0.0 Number of Days | Standard Deviation 1.68 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with timed voiding- Baseline (N=364; 365) | 12.1 Number of Days | Standard Deviation 29.35 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with timed voiding- EOT (N=356; 360) | 7.4 Number of Days | Standard Deviation 23.13 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with timed voiding-Change at EOT(N=347; 350) | -5.3 Number of Days | Standard Deviation 33.66 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with fluid management-Baseline(N=368; 369) | 22.1 Number of Days | Standard Deviation 38.38 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with fluid management- EOT (N=355; 366) | 11.5 Number of Days | Standard Deviation 25.1 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with fluid management-Change at EOT(349; 360) | -11.0 Number of Days | Standard Deviation 40.43 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ pelvic floor exercises-Baseline(364; 366) | 9.2 Number of Days | Standard Deviation 22.78 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ pelvic floor exercises- EOT (N=352; 358) | 5.5 Number of Days | Standard Deviation 17.31 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/pelvic flr exercises-Change atEOT(344; 349) | -3.2 Number of Days | Standard Deviation 19.43 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with biofeedback- Baseline (N=359; 360) | 0.1 Number of Days | Standard Deviation 0.95 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with biofeedback- EOT (N=352; 358) | 0.0 Number of Days | Standard Deviation 0.45 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days with biofeedback- Change at EOT (N=338; 343) | 0.0 Number of Days | Standard Deviation 1.08 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ electrical stimulation-Baseline (358; 362) | 0.1 Number of Days | Standard Deviation 1.58 |
| Solifenacin Succinate | Change From Baseline in the MCUI Behavior Therapy Stratified | days w/ electrical stimulation- EOT (N=352; 358) | 0.1 Number of Days | Standard Deviation 0.56 |
Secondary
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication \& had an assessment in OAB-q at both baseline \& at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | urinary tract infections- EOT (N=358; 362) | 0.1 Number of categorical items | Standard Deviation 0.28 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | skin rashes- Change at EOT (N=347; 351) | 0.0 Number of categorical items | Standard Deviation 8.17 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | physician office visits- EOT (N=362; 366) | 0.2 Number of categorical items | Standard Deviation 0.62 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | falls- Baseline (N=365; 364) | 0.2 Number of categorical items | Standard Deviation 0.86 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | urinary tract infections-Change at EOT (355; 356) | -0.1 Number of categorical items | Standard Deviation 0.38 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | falls- EOT (N=356; 358) | 0.1 Number of categorical items | Standard Deviation 0.72 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | urinary tract infections-Baseline (N=371; 370) | 0.1 Number of categorical items | Standard Deviation 0.37 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | falls- Change at EOT (N=347; 349) | -0.1 Number of categorical items | Standard Deviation 0.69 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | skin rashes- Baseline (N=367; 368) | 1.5 Number of categorical items | Standard Deviation 10.52 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | pad/diapers used/ week- Baseline (N=371; 375) | 10.0 Number of categorical items | Standard Deviation 19.17 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | physician office visits- Change at EOT(359; 365) | -0.4 Number of categorical items | Standard Deviation 1.29 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | pad/diapers used/ week- EOT (N=360; 364) | 9.8 Number of categorical items | Standard Deviation 24.07 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | skin rashes- EOT (N=354; 357) | 1.0 Number of categorical items | Standard Deviation 7.7 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | pad/diapers used/ week- Change at EOT(N=357; 362) | -0.2 Number of categorical items | Standard Deviation 26.6 |
| Placebo | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | physician office visits- Baseline (N=371; 375) | 0.5 Number of categorical items | Standard Deviation 1.3 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | pad/diapers used/ week- Change at EOT(N=357; 362) | -2.1 Number of categorical items | Standard Deviation 42.01 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | physician office visits- Baseline (N=371; 375) | 0.5 Number of categorical items | Standard Deviation 1.22 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | physician office visits- EOT (N=362; 366) | 0.2 Number of categorical items | Standard Deviation 0.79 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | physician office visits- Change at EOT(359; 365) | -0.3 Number of categorical items | Standard Deviation 1.23 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | urinary tract infections-Baseline (N=371; 370) | 0.1 Number of categorical items | Standard Deviation 0.46 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | urinary tract infections- EOT (N=358; 362) | 0.1 Number of categorical items | Standard Deviation 0.5 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | urinary tract infections-Change at EOT (355; 356) | 0.0 Number of categorical items | Standard Deviation 0.57 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | skin rashes- Baseline (N=367; 368) | 0.3 Number of categorical items | Standard Deviation 1.87 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | skin rashes- EOT (N=354; 357) | 0.2 Number of categorical items | Standard Deviation 1.83 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | skin rashes- Change at EOT (N=347; 351) | -0.1 Number of categorical items | Standard Deviation 1.63 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | falls- Baseline (N=365; 364) | 0.2 Number of categorical items | Standard Deviation 0.83 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | falls- EOT (N=356; 358) | 0.5 Number of categorical items | Standard Deviation 5.87 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | falls- Change at EOT (N=347; 349) | 0.2 Number of categorical items | Standard Deviation 5.83 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | pad/diapers used/ week- Baseline (N=371; 375) | 10.4 Number of categorical items | Standard Deviation 20.68 |
| Solifenacin Succinate | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | pad/diapers used/ week- EOT (N=360; 364) | 8.3 Number of categorical items | Standard Deviation 40.58 |
Secondary
Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely). Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study. Change is calculated as EOT - Baseline
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each row are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) | Baseline (N=363; 367) | 32.7 TS-VAS | Standard Deviation 35.29 |
| Placebo | Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) | End of Treatment (N=363; 367) | 51.2 TS-VAS | Standard Deviation 38.1 |
| Placebo | Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) | Change at EOT (N=352; 357) | 18.4 TS-VAS | Standard Deviation 47.28 |
| Solifenacin Succinate | Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) | Baseline (N=363; 367) | 29.0 TS-VAS | Standard Deviation 33.99 |
| Solifenacin Succinate | Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) | End of Treatment (N=363; 367) | 67.4 TS-VAS | Standard Deviation 34.38 |
| Solifenacin Succinate | Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) | Change at EOT (N=352; 357) | 38.2 TS-VAS | Standard Deviation 45.38 |
Comparison: Statistical Analysis applies to 'Change at EOT'.p-value: <0.000195% CI: [-22.1, -11.6]ANCOVA
Secondary
Change From Baseline in Work Productivity Assessment Index (WPAI)
The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change from baseline is based on the ANCOVA model after adjusting baseline value & center.
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set (FAS): all randomized patients who took at least 1 dose of double-blind study drug \& had an OAB-q assessment at both baseline \& at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint / parameter are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % work time missed- Baseline (N=175;175) | 1.4 Percentage of indicated parameter | Standard Deviation 8.6 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % work time missed- EOT (N=161;157) | 0.8 Percentage of indicated parameter | Standard Deviation 5.85 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % work time missed- Change at EOT (N=145;142) | 0.1 Percentage of indicated parameter | Standard Deviation 4.26 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % impairment while working- Baseline(N=203;194) | 27.5 Percentage of indicated parameter | Standard Deviation 25.93 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % impairment while working- EOT (N=193;197) | 18.4 Percentage of indicated parameter | Standard Deviation 21.11 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % impairment working-Change at EOT(N=172;175) | -8.7 Percentage of indicated parameter | Standard Deviation 23.03 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % overall work impairment- Baseline (N=174;175) | 28.5 Percentage of indicated parameter | Standard Deviation 25.77 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % overall work impairment- EOT (N=161;157) | 20.8 Percentage of indicated parameter | Standard Deviation 21.81 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | %overall work impairment-Change at EOT(N=145;142) | -8.2 Percentage of indicated parameter | Standard Deviation 22.59 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | %activity impairment- Baseline (N=368;375) | 38.6 Percentage of indicated parameter | Standard Deviation 28.36 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % activity impairment- EOT (N=357;362) | 23.4 Percentage of indicated parameter | Standard Deviation 23.17 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI) | % activity impairment- Change at EOT(N=351;360) | -14.7 Percentage of indicated parameter | Standard Deviation 25.46 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % activity impairment- EOT (N=357;362) | 19.2 Percentage of indicated parameter | Standard Deviation 22.32 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % work time missed- Baseline (N=175;175) | 1.1 Percentage of indicated parameter | Standard Deviation 3.54 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % overall work impairment- Baseline (N=174;175) | 28.2 Percentage of indicated parameter | Standard Deviation 25.29 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % work time missed- EOT (N=161;157) | 0.5 Percentage of indicated parameter | Standard Deviation 2.04 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | %activity impairment- Baseline (N=368;375) | 37.3 Percentage of indicated parameter | Standard Deviation 27.44 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % work time missed- Change at EOT (N=145;142) | -0.5 Percentage of indicated parameter | Standard Deviation 3.34 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % overall work impairment- EOT (N=161;157) | 14.1 Percentage of indicated parameter | Standard Deviation 18.67 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % impairment while working- Baseline(N=203;194) | 27.6 Percentage of indicated parameter | Standard Deviation 25.72 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % activity impairment- Change at EOT(N=351;360) | -18.1 Percentage of indicated parameter | Standard Deviation 26.26 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % impairment while working- EOT (N=193;197) | 13.2 Percentage of indicated parameter | Standard Deviation 18.19 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | %overall work impairment-Change at EOT(N=145;142) | -12.9 Percentage of indicated parameter | Standard Deviation 23 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI) | % impairment working-Change at EOT(N=172;175) | -14.6 Percentage of indicated parameter | Standard Deviation 24.09 |
Secondary
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated as Actual Data for each time point - Baseline.
Time frame: Baseline, Week 4, Week 8 and Week 12
Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Change at Week 4(N=371; 370) | 13.5 OAB-q HRQL Total Score | Standard Deviation 17.92 |
| Placebo | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Change at Week 8 (N=342; 356) | 17.3 OAB-q HRQL Total Score | Standard Deviation 19 |
| Placebo | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Week 4 (N=371; 370) | 71.4 OAB-q HRQL Total Score | Standard Deviation 21.42 |
| Placebo | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Week 12 (N=318; 339) | 76.7 OAB-q HRQL Total Score | Standard Deviation 20.53 |
| Placebo | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Week 8 (N=342; 356) | 75.2 OAB-q HRQL Total Score | Standard Deviation 21.06 |
| Placebo | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Change at Week 12(N=318; 339) | 18.0 OAB-q HRQL Total Score | Standard Deviation 19.39 |
| Placebo | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Baseline (N= 374 ; 377) | 57.8 OAB-q HRQL Total Score | Standard Deviation 21.34 |
| Solifenacin Succinate | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Change at Week 12(N=318; 339) | 25.8 OAB-q HRQL Total Score | Standard Deviation 22.3 |
| Solifenacin Succinate | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Baseline (N= 374 ; 377) | 56.4 OAB-q HRQL Total Score | Standard Deviation 22.1 |
| Solifenacin Succinate | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Week 4 (N=371; 370) | 76.0 OAB-q HRQL Total Score | Standard Deviation 20.81 |
| Solifenacin Succinate | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Change at Week 4(N=371; 370) | 19.3 OAB-q HRQL Total Score | Standard Deviation 19.43 |
| Solifenacin Succinate | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Week 8 (N=342; 356) | 80.5 OAB-q HRQL Total Score | Standard Deviation 19.94 |
| Solifenacin Succinate | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Change at Week 8 (N=342; 356) | 24.4 OAB-q HRQL Total Score | Standard Deviation 21.35 |
| Solifenacin Succinate | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Week 12 (N=318; 339) | 82.2 OAB-q HRQL Total Score | Standard Deviation 19.64 |
Comparison: Statistical Analysis applies to 'Change at Week 12'.p-value: <0.0001ANCOVA
Secondary
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. Change is calculated as Actual Data for each timepoint - Baseline.
Time frame: Baseline, Week 4, Week 8 and Week 12
Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Baseline ( N= 374 ; 377) | 57.9 OAB-q Score | Standard Deviation 18.18 |
| Placebo | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Week 4 (N=371; 370) | 41.6 OAB-q Score | Standard Deviation 21.04 |
| Placebo | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Change at Week 4 (N=371; 370) | -16.4 OAB-q Score | Standard Deviation 19.33 |
| Placebo | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Week 8 (N=342; 356) | 37.0 OAB-q Score | Standard Deviation 21.86 |
| Placebo | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Change at Week 8 (N=342; 356) | -21.0 OAB-q Score | Standard Deviation 20.64 |
| Placebo | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Week 12 (N=318; 339) | 36.0 OAB-q Score | Standard Deviation 21.91 |
| Placebo | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Change at Week 12 (N=318; 339) | -21.7 OAB-q Score | Standard Deviation 21.52 |
| Solifenacin Succinate | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Change at Week 8 (N=342; 356) | -28.9 OAB-q Score | Standard Deviation 22.11 |
| Solifenacin Succinate | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Baseline ( N= 374 ; 377) | 58.2 OAB-q Score | Standard Deviation 18.75 |
| Solifenacin Succinate | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Week 8 (N=342; 356) | 29.8 OAB-q Score | Standard Deviation 20.23 |
| Solifenacin Succinate | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Week 4 (N=371; 370) | 35.5 OAB-q Score | Standard Deviation 20.77 |
| Solifenacin Succinate | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Week 12 (N=318; 339) | 27.6 OAB-q Score | Standard Deviation 20.32 |
| Solifenacin Succinate | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Change at Week 12 (N=318; 339) | -30.9 OAB-q Score | Standard Deviation 22.29 |
| Solifenacin Succinate | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Change at Week 4 (N=371; 370) | -22.6 OAB-q Score | Standard Deviation 20.55 |
Comparison: Statistical Analysis applies to 'Change at Week 4', 'Change at Week 8' and 'Change at Week 12'.p-value: <0.0001ANCOVA
Secondary
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated End of Treatment (EOT) for each sub-domain - Baseline.
Time frame: Baseline, Week 4, Week 8 and Week 12
Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~Number of participants analyzed per arm represents FAS. The numbers of participants for each visit/sub domain are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Coping- Baseline (N= 374 ; 377) | 53.7 OAB-q HRQL Sub Domain Score | Standard Deviation 25.78 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Coping- Change at Week 4 (N=371; 370) | 14.9 OAB-q HRQL Sub Domain Score | Standard Deviation 21.55 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Coping- Change at Week 8 (N=342; 356) | 18.9 OAB-q HRQL Sub Domain Score | Standard Deviation 21.97 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Coping- Change at Week 12 (N=318; 339) | 19.9 OAB-q HRQL Sub Domain Score | Standard Deviation 22.56 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Concern- Baseline (N= 374 ; 377) | 52.0 OAB-q HRQL Sub Domain Score | Standard Deviation 25.49 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Concern- Change at Week 4 (N=371; 370) | 15.8 OAB-q HRQL Sub Domain Score | Standard Deviation 21.58 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Concern- Change at Week 8 (N=342; 356) | 19.8 OAB-q HRQL Sub Domain Score | Standard Deviation 22.87 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Concern- Change at Week 12 (N=318; 339) | 20.9 OAB-q HRQL Sub Domain Score | Standard Deviation 23.1 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Sleep- Baseline (N= 374 ; 377) | 51.3 OAB-q HRQL Sub Domain Score | Standard Deviation 25.78 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Sleep- Change at Week 4 (N=371; 370) | 13.9 OAB-q HRQL Sub Domain Score | Standard Deviation 22.91 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Sleep- Change at Week 8 (N=342; 356) | 18.7 OAB-q HRQL Sub Domain Score | Standard Deviation 24.46 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Sleep- Change at Week 12 (N=318; 339) | 19.0 OAB-q HRQL Sub Domain Score | Standard Deviation 24.65 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Social- Baseline (N= 374 ; 377) | 78.9 OAB-q HRQL Sub Domain Score | Standard Deviation 23.13 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Social- Change at Week 4 (N=371; 370) | 7.8 OAB-q HRQL Sub Domain Score | Standard Deviation 16.51 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Social- Change at Week 8 (N=340; 356) | 9.4 OAB-q HRQL Sub Domain Score | Standard Deviation 16.49 |
| Placebo | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Social- Change at Week 12 (N=318; 339) | 10.0 OAB-q HRQL Sub Domain Score | Standard Deviation 17.81 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Social- Change at Week 12 (N=318; 339) | 13.7 OAB-q HRQL Sub Domain Score | Standard Deviation 21.38 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Coping- Baseline (N= 374 ; 377) | 52.2 OAB-q HRQL Sub Domain Score | Standard Deviation 26.76 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Sleep- Baseline (N= 374 ; 377) | 47.3 OAB-q HRQL Sub Domain Score | Standard Deviation 27.55 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Coping- Change at Week 4 (N=371; 370) | 22.2 OAB-q HRQL Sub Domain Score | Standard Deviation 22.2 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Social- Baseline (N= 374 ; 377) | 78.7 OAB-q HRQL Sub Domain Score | Standard Deviation 23.56 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Coping- Change at Week 8 (N=342; 356) | 27.0 OAB-q HRQL Sub Domain Score | Standard Deviation 24.81 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Sleep- Change at Week 4 (N=371; 370) | 19.3 OAB-q HRQL Sub Domain Score | Standard Deviation 23.68 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Coping- Change at Week 12 (N=318; 339) | 28.8 OAB-q HRQL Sub Domain Score | Standard Deviation 25.22 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Social- Change at Week 8 (N=340; 356) | 13.1 OAB-q HRQL Sub Domain Score | Standard Deviation 19.65 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Concern- Baseline (N= 374 ; 377) | 51.9 OAB-q HRQL Sub Domain Score | Standard Deviation 26.06 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Sleep- Change at Week 8 (N=342; 356) | 26.2 OAB-q HRQL Sub Domain Score | Standard Deviation 24.94 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Concern- Change at Week 4 (N=371; 370) | 22.4 OAB-q HRQL Sub Domain Score | Standard Deviation 23.37 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Social- Change at Week 4 (N=371; 370) | 10.3 OAB-q HRQL Sub Domain Score | Standard Deviation 18.66 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Concern- Change at Week 8 (N=342; 356) | 28.4 OAB-q HRQL Sub Domain Score | Standard Deviation 25.64 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Sleep- Change at Week 12 (N=318; 339) | 27.5 OAB-q HRQL Sub Domain Score | Standard Deviation 26.56 |
| Solifenacin Succinate | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Concern- Change at Week 12 (N=318; 339) | 29.9 OAB-q HRQL Sub Domain Score | Standard Deviation 26.32 |
Secondary
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids. Change from baseline with a lower score indicates an improvement. End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table. Change is calculated as EOT - Baseline
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study drug \& had an OAB-q assessment at both baseline \& at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The number of participants for each timepoint / parameter are noted in the category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Incontinence Episodes-End of Treatment (N=267;268) | 1.56 Number of Category Events / 24 Hours | Standard Deviation 2.338 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Urgency Episodes- Change at EOT (N=364;369) | -1.84 Number of Category Events / 24 Hours | Standard Deviation 3.891 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Micturitions- End of Treatment (N=363;369) | 10.49 Number of Category Events / 24 Hours | Standard Deviation 3.645 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturia Episodes- Baseline (N=309;313) | 1.57 Number of Category Events / 24 Hours | Standard Deviation 0.968 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Incontinence Episodes-Change at EOT (N=267;268) | -1.24 Number of Category Events / 24 Hours | Standard Deviation 2.545 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturia Episodes- End of Treatment (N=309;313) | 1.09 Number of Category Events / 24 Hours | Standard Deviation 1.025 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Incontinence Episodes- Baseline (N=267;268) | 2.80 Number of Category Events / 24 Hours | Standard Deviation 2.584 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturia Episodes- Change at EOT (N=309;313) | -0.48 Number of Category Events / 24 Hours | Standard Deviation 1.015 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Urgency Episodes- Baseline (N=364;369) | 5.70 Number of Category Events / 24 Hours | Standard Deviation 3.895 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturnal Voids- Baseline (N=329;326) | 1.89 Number of Category Events / 24 Hours | Standard Deviation 1.429 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Micturitions- Change at EOT (N=363;369) | -1.36 Number of Category Events / 24 Hours | Standard Deviation 3.203 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturnal Voids- End of Treatment (N=329;326) | 1.41 Number of Category Events / 24 Hours | Standard Deviation 1.299 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Urgency Episodes- End of Treatment (N=364;369) | 3.86 Number of Category Events / 24 Hours | Standard Deviation 3.795 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturnal Voids- Change at EOT (N=329;326) | -0.48 Number of Category Events / 24 Hours | Standard Deviation 1.542 |
| Placebo | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Micturitions- Baseline (N=363;369) | 11.85 Number of Category Events / 24 Hours | Standard Deviation 4.039 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturnal Voids- Change at EOT (N=329;326) | -0.70 Number of Category Events / 24 Hours | Standard Deviation 1.513 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Micturitions- Baseline (N=363;369) | 11.73 Number of Category Events / 24 Hours | Standard Deviation 3.693 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Micturitions- End of Treatment (N=363;369) | 9.50 Number of Category Events / 24 Hours | Standard Deviation 3.869 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Micturitions- Change at EOT (N=363;369) | -2.23 Number of Category Events / 24 Hours | Standard Deviation 3.482 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Incontinence Episodes- Baseline (N=267;268) | 2.92 Number of Category Events / 24 Hours | Standard Deviation 2.743 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Incontinence Episodes-End of Treatment (N=267;268) | 1.07 Number of Category Events / 24 Hours | Standard Deviation 2.156 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Incontinence Episodes-Change at EOT (N=267;268) | -1.85 Number of Category Events / 24 Hours | Standard Deviation 2.484 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Urgency Episodes- Baseline (N=364;369) | 5.72 Number of Category Events / 24 Hours | Standard Deviation 3.734 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Urgency Episodes- End of Treatment (N=364;369) | 2.66 Number of Category Events / 24 Hours | Standard Deviation 3.381 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Urgency Episodes- Change at EOT (N=364;369) | -3.05 Number of Category Events / 24 Hours | Standard Deviation 3.932 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturia Episodes- Baseline (N=309;313) | 1.74 Number of Category Events / 24 Hours | Standard Deviation 1.191 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturia Episodes- End of Treatment (N=309;313) | 1.11 Number of Category Events / 24 Hours | Standard Deviation 1.241 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturia Episodes- Change at EOT (N=309;313) | -0.63 Number of Category Events / 24 Hours | Standard Deviation 1.132 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturnal Voids- Baseline (N=329;326) | 1.99 Number of Category Events / 24 Hours | Standard Deviation 1.52 |
| Solifenacin Succinate | Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | Nocturnal Voids- End of Treatment (N=329;326) | 1.29 Number of Category Events / 24 Hours | Standard Deviation 1.352 |
Secondary
Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems Improvement is defined by any reduction in PPBC score. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline
Time frame: Baseline and 12 Weeks
Population: Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) | Improvement from Baseline to End of Treatment | 231 Participants |
| Placebo | Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) | No Improvement from Baseline to End of Treatment | 131 Participants |
| Solifenacin Succinate | Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) | Improvement from Baseline to End of Treatment | 278 Participants |
| Solifenacin Succinate | Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) | No Improvement from Baseline to End of Treatment | 90 Participants |
p-value: 0.0006ANCOVA
Secondary
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy.
Time frame: Baseline and 12 Weeks
Population: The number assessed included all participants who completed the BSW questionnaire at baseline visit (visit 2) and end of treatment (visit 5/early withdrawal).~A few patients who completed the BSW Questionnaire did not adequately complete the Benefits Section and therefore are considered 'N/A' for that Section.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Benefit from Treatment - No | 115 Participants |
| Placebo | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Benefit from Treatment - Little | 90 Participants |
| Placebo | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Benefit from Treatment - Much | 109 Participants |
| Placebo | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Benifit from Treatment - N/A | 2 Participants |
| Placebo | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Satisfied with Treatment - No | 129 Participants |
| Placebo | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Satisfied with Treatment - Yes | 187 Participants |
| Placebo | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Willingness to Continue - No | 128 Participants |
| Placebo | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Willingness to Continue - Yes | 188 Participants |
| Solifenacin Succinate | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Willingness to Continue - Yes | 264 Participants |
| Solifenacin Succinate | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Benefit from Treatment - No | 53 Participants |
| Solifenacin Succinate | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Satisfied with Treatment - No | 66 Participants |
| Solifenacin Succinate | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Benefit from Treatment - Little | 80 Participants |
| Solifenacin Succinate | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Willingness to Continue - No | 71 Participants |
| Solifenacin Succinate | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Benefit from Treatment - Much | 196 Participants |
| Solifenacin Succinate | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Satisfied with Treatment - Yes | 269 Participants |
| Solifenacin Succinate | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Benifit from Treatment - N/A | 6 Participants |