Urinary Incontinence
Conditions
Keywords
Radical Robotic Arm, Vesicare, Post Prostatectomy Incontinence, YM905
Brief summary
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy. This study will also assess the effect of 12 weeks of treatment with solifenacin succinate versus placebo on quality of life (QOL) as measured by questionnaires.
Detailed description
The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits. Participants will complete an electronic daily pad use diary during the study duration. Participants will also be asked to complete several questionnaires during the study.
Interventions
DRUGsolifenacin succinate
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ambulatory * Willing and able to complete the daily pad use diary, American Urology Association Symptom Score (AUASS) with Bother Score, the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and the Work Productivity and Activity Impairment Questionnaire (WPAI) * Has not used any medication for over-active bladder symptoms for at least 14 days prior to enrollment * Diagnosed with prostate cancer, treated by Robotic Assisted Radical Prostatectomy, is voiding spontaneously and has urinary incontinence one week after removal of the indwelling catheter which requires management with 2 to 10 pads inclusive per day (24 hour days) for 7 consecutive days
Exclusion criteria
* Evidence of severe neurologic damage post-prostatectomy * Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stone; uncontrolled narrow angle glaucoma; urinary or gastric retention or neurogenic bladder * Symptomatic for urinary tract infection or has a urine culture result which requires treatment as determined by the investigator. * Clinically significant history of hepatic or renal impairment (2 X Upper Limit of Normal (ULN) values in alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine clearance \< 30 ml/min) * History of diagnosed gastrointestinal obstruction disease * Any prior history of local radiation therapy to the prostate or rectum or any prior hormonal therapy or has planned such therapy during study conduct * Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics * Treated with any investigational drug within last 30 days * History of a clinically significant illness or medical condition that would preclude participation in the study * Diagnosed with New York Heart Association Class III and IV heart failure * Any of the following peri-operative laboratory results: ALT \> 2.0 ULN, AST \> 2.0 ULN, serum creatinine \> 1.5 mg/L, blood glucose \> 130 mg/dL, blood urea nitrogen (BUN) \> 23 mg/dL. * Severe hypertension on peri-operative evaluation which is defined as a sitting systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg, and which is not corrected * Electrolytes (sodium, potassium, chloride or bicarbonate) that are not in normal range and clinically significant as determined by the investigator in the perioperative period. Can be eligible if electrolytes are corrected to within normal range prior to randomization * Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From First Dose to Urinary Continence | 12 weeks | Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Pad Usage at Baseline | Baseline (7 days prior to Day 1) | Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage. |
| Change From Baseline in Average Daily Pad Usage | Baseline and Weeks 4, 8 and 12 | Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage. End of treatment is the last on-treatment assessment during the treatment period. |
| American Urology Association Symptom Score (AUASS) at Baseline | Baseline | Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst). |
| Change From Baseline in American Urology Association Symptom Score (AUASS) | Baseline and Week 12 | Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst). End of treatment is the last on-treatment assessment during the treatment period. |
| American Urology Association Quality of Life (QOL) Score at Baseline | Baseline | The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible). |
| Change From Baseline in American Urology Association Quality of Life (QOL) Score | Baseline and Week 12 | The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible). End of treatment is the last on-treatment assessment during the treatment period. |
| International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline | Baseline | The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother). |
| Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score | Baseline and Week 12 | The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother). |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Weeks 4, 8, and 12 | Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. End of treatment is the last on-treatment assessment during the treatment period. |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Baseline and Week 12 | Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement. |
| Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | Baseline | Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. |
| Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working | Baseline and Week 12 | Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. |
| Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Baseline | Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Baseline and Week 12 | Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. |
| Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Baseline | Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Baseline and Week 12 | Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement. |
| Time From Baseline to First Day of Returning to Work | From Baseline to Week 12 | The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method. |
| Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Baseline | Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. |
Countries
Canada, United States
Participant flow
Recruitment details
The study population consisted of male patients \> 18 years of age who were diagnosed with prostate cancer, treated by robotic assisted radical prostatectomy (RARP) and had urinary incontinence for 1 week following removal of the indwelling catheter.
Pre-assignment details
Participants meeting the Baseline criteria were randomized 1:1 to 5 mg solifenacin succinate or matching placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo tablets once a day for 12 weeks. | 310 |
| Solifenacin Succinate Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily. | 313 |
| Total | 623 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 6 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Miscellaneous Reasons | 6 | 4 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 24 | 17 |
| Overall Study | Randomized but Never Received Study Drug | 6 | 6 |
| Overall Study | Withdrawal by Subject | 13 | 7 |
Baseline characteristics
| Characteristic | Placebo | Solifenacin Succinate | Total |
|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 6.72 | 60.5 years STANDARD_DEVIATION 7.21 | 60.9 years STANDARD_DEVIATION 6.98 |
| Race/Ethnicity, Customized Asian | 2 participants | 3 participants | 5 participants |
| Race/Ethnicity, Customized Black | 43 participants | 44 participants | 87 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 26 participants | 29 participants | 55 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 284 participants | 284 participants | 568 participants |
| Race/Ethnicity, Customized Other | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White | 263 participants | 266 participants | 529 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 310 Participants | 313 Participants | 623 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 310 | 19 / 313 |
| serious Total, serious adverse events | 5 / 310 | 7 / 313 |
Outcome results
Primary
Time From First Dose to Urinary Continence
Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.
Time frame: 12 weeks
Population: Full analysis set defined as all randomized participants who took at least one dose of study drug and had at least one efficacy endpoint evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From First Dose to Urinary Continence | NA days |
| Solifenacin Succinate | Time From First Dose to Urinary Continence | NA days |
Comparison: The treatment difference in the primary efficacy variable was tested using a log-rank test stratified by (pooled) center and by Baseline daily pad usage (≤3 and \>3) at a 2-sided significance level of 0.05.p-value: 0.1745Log Rank
Secondary
American Urology Association Quality of Life (QOL) Score at Baseline
The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).
Time frame: Baseline
Population: Full analysis set with available AUA QOL data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | American Urology Association Quality of Life (QOL) Score at Baseline | 4.8 units on a scale | Standard Deviation 1.22 |
| Solifenacin Succinate | American Urology Association Quality of Life (QOL) Score at Baseline | 4.7 units on a scale | Standard Deviation 1.25 |
Secondary
American Urology Association Symptom Score (AUASS) at Baseline
Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).
Time frame: Baseline
Population: Full analysis set with available AUASS data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | American Urology Association Symptom Score (AUASS) at Baseline | 16.7 units on a scale | Standard Deviation 7.07 |
| Solifenacin Succinate | American Urology Association Symptom Score (AUASS) at Baseline | 16.2 units on a scale | Standard Deviation 7.22 |
Secondary
Average Daily Pad Usage at Baseline
Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.
Time frame: Baseline (7 days prior to Day 1)
Population: Full analysis set with available pad usage data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Average Daily Pad Usage at Baseline | 5.0 pads | Standard Deviation 2.3 |
| Solifenacin Succinate | Average Daily Pad Usage at Baseline | 4.7 pads | Standard Deviation 2.16 |
Secondary
Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity.
Time frame: Baseline
Population: Full analysis set participants with available WPAI data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | 41.6 percent activity impairment | Standard Deviation 28.38 |
| Solifenacin Succinate | Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | 41.4 percent activity impairment | Standard Deviation 27.49 |
Secondary
Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.
Time frame: Baseline
Population: Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | 35.5 percent impairment while working | Standard Deviation 30.05 |
| Solifenacin Succinate | Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working | 34.1 percent impairment while working | Standard Deviation 29.7 |
Secondary
Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.
Time frame: Baseline
Population: Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | 42.5 percent overall work impairment | Standard Deviation 35.26 |
| Solifenacin Succinate | Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | 44.8 percent overall work impairment | Standard Deviation 33.41 |
Secondary
Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed.
Time frame: Baseline
Population: Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | 43.6 percent work time missed | Standard Deviation 46.22 |
| Solifenacin Succinate | Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | 37.9 percent work time missed | Standard Deviation 45.5 |
Secondary
Change From Baseline in American Urology Association Quality of Life (QOL) Score
The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible). End of treatment is the last on-treatment assessment during the treatment period.
Time frame: Baseline and Week 12
Population: Full analysis set with available AUA data at both Baseline and each time point; n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in American Urology Association Quality of Life (QOL) Score | Week 12 (n=261, 276) | -1.9 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in American Urology Association Quality of Life (QOL) Score | End of treatment (n=292, 306) | -1.8 units on a scale | Standard Error 0.09 |
| Solifenacin Succinate | Change From Baseline in American Urology Association Quality of Life (QOL) Score | Week 12 (n=261, 276) | -2.1 units on a scale | Standard Error 0.1 |
| Solifenacin Succinate | Change From Baseline in American Urology Association Quality of Life (QOL) Score | End of treatment (n=292, 306) | -2.0 units on a scale | Standard Error 0.09 |
Comparison: Comparison at Week 12p-value: 0.149395% CI: [-0.07, 0.47]ANCOVA
Comparison: Comparison of end of treatment analysisp-value: 0.149995% CI: [-0.07, 0.44]ANCOVA
Secondary
Change From Baseline in American Urology Association Symptom Score (AUASS)
Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always). The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst). End of treatment is the last on-treatment assessment during the treatment period.
Time frame: Baseline and Week 12
Population: Full analysis set with available AUASS data at both Baseline and each time point; n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in American Urology Association Symptom Score (AUASS) | Week 12 (n=262, 277) | -7.7 units on a scale | Standard Error 0.33 |
| Placebo | Change From Baseline in American Urology Association Symptom Score (AUASS) | End of treatment (n=293, 307) | -7.4 units on a scale | Standard Error 0.31 |
| Solifenacin Succinate | Change From Baseline in American Urology Association Symptom Score (AUASS) | Week 12 (n=262, 277) | -8.0 units on a scale | Standard Error 0.32 |
| Solifenacin Succinate | Change From Baseline in American Urology Association Symptom Score (AUASS) | End of treatment (n=293, 307) | -7.7 units on a scale | Standard Error 0.31 |
Comparison: Comparison at Week 12p-value: 0.518695% CI: [-0.6, 1.19]ANCOVA
Comparison: Comparison of end of treatment analysisp-value: 0.452195% CI: [-0.52, 1.17]ANCOVA
Secondary
Change From Baseline in Average Daily Pad Usage
Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage. End of treatment is the last on-treatment assessment during the treatment period.
Time frame: Baseline and Weeks 4, 8 and 12
Population: Full analysis set with available pad usage data at both Baseline and each time point; n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Average Daily Pad Usage | Week 4 (n=297, 302) | -1.9 pads | Standard Error 0.1 |
| Placebo | Change From Baseline in Average Daily Pad Usage | Week 8 (n=280, 292) | -2.5 pads | Standard Error 0.1 |
| Placebo | Change From Baseline in Average Daily Pad Usage | Week 12 (n=226, 226) | -3.1 pads | Standard Error 0.1 |
| Placebo | Change From Baseline in Average Daily Pad Usage | End of treatment (n=298, 302) | -2.9 pads | Standard Error 0.09 |
| Solifenacin Succinate | Change From Baseline in Average Daily Pad Usage | End of treatment (n=298, 302) | -3.2 pads | Standard Error 0.09 |
| Solifenacin Succinate | Change From Baseline in Average Daily Pad Usage | Week 4 (n=297, 302) | -2.0 pads | Standard Error 0.09 |
| Solifenacin Succinate | Change From Baseline in Average Daily Pad Usage | Week 12 (n=226, 226) | -3.4 pads | Standard Error 0.1 |
| Solifenacin Succinate | Change From Baseline in Average Daily Pad Usage | Week 8 (n=280, 292) | -2.8 pads | Standard Error 0.1 |
Comparison: Comparison at Week 4p-value: 0.360495% CI: [-0.14, 0.38]ANCOVA
Comparison: Comparison at Week 8p-value: 0.076195% CI: [-0.03, 0.52]ANCOVA
Comparison: Comparison at Week 12p-value: 0.014995% CI: [0.07, 0.64]ANCOVA
Comparison: Comparison of end of treatment analysisp-value: 0.032595% CI: [0.02, 0.52]ANCOVA
Secondary
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score
The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).
Time frame: Baseline and Week 12
Population: Full analysis set with available ICIQ-SF data at both Baseline and each time point; n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score | Week 12 (n=262, 277) | -5.7 units on a scale | Standard Error 0.26 |
| Placebo | Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score | End of treatment (n=292, 307) | -5.5 units on a scale | Standard Error 0.25 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score | Week 12 (n=262, 277) | -6.2 units on a scale | Standard Error 0.25 |
| Solifenacin Succinate | Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score | End of treatment (n=292, 307) | -6.0 units on a scale | Standard Error 0.24 |
Comparison: Comparison at Week 12p-value: 0.127995% CI: [-0.16, 1.23]ANCOVA
Comparison: Comparison of end of treatment analysisp-value: 0.103895% CI: [-0.11, 1.23]ANCOVA
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 12
Population: Full analysis set with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Week 12 (n=115, 129) | -28.2 Percent activity impairment | Standard Error 1.93 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | End of treatment (n=124, 145) | -28.4 Percent activity impairment | Standard Error 1.95 |
| Solifenacin Succinate | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | Week 12 (n=115, 129) | -30.2 Percent activity impairment | Standard Error 1.82 |
| Solifenacin Succinate | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment | End of treatment (n=124, 145) | -28.8 Percent activity impairment | Standard Error 1.78 |
Comparison: Comparison at Week 12p-value: 0.406795% CI: [-2.8, 6.89]ANCOVA
Comparison: Comparison of end of treatment analysisp-value: 0.850795% CI: [-4.21, 5.1]ANCOVA
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 12
Population: Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Week 12 (n= 59, 69) | -30.4 percent overall work impairment | Standard Error 2.18 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | End of treatment (n=65, 79) | -30.0 percent overall work impairment | Standard Error 2.23 |
| Solifenacin Succinate | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | Week 12 (n= 59, 69) | -33.7 percent overall work impairment | Standard Error 1.94 |
| Solifenacin Succinate | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment | End of treatment (n=65, 79) | -31.1 percent overall work impairment | Standard Error 1.95 |
Comparison: Comparison at Week 12p-value: 0.240295% CI: [-2.26, 8.91]ANCOVA
Comparison: Comparison of end of treatment analysisp-value: 0.69895% CI: [-4.5, 6.7]ANCOVA
Secondary
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 12
Population: Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Week 12 (n= 81, 88) | -37.9 Percent work time missed | Standard Error 1.51 |
| Placebo | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | End of treatment (n=88, 102) | -36.8 Percent work time missed | Standard Error 2.25 |
| Solifenacin Succinate | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | Week 12 (n= 81, 88) | -37.6 Percent work time missed | Standard Error 1.42 |
| Solifenacin Succinate | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed | End of treatment (n=88, 102) | -34.4 Percent work time missed | Standard Error 2.04 |
Comparison: Comparison at Week 12p-value: 0.887695% CI: [-4.19, 3.63]ANCOVA
Comparison: Comparison of end of treatment analysisp-value: 0.39595% CI: [-8.1, 3.21]ANCOVA
Secondary
Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working
Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 12
Population: Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working | Week 12 (n=66, 80) | -21.8 percent impairment while working | Standard Error 1.89 |
| Placebo | Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working | End of treatment (n=72, 91) | -20.8 percent impairment while working | Standard Error 1.96 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working | Week 12 (n=66, 80) | -23.8 percent impairment while working | Standard Error 1.71 |
| Solifenacin Succinate | Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working | End of treatment (n=72, 91) | -21.8 percent impairment while working | Standard Error 1.72 |
Comparison: Comparison at Week 12p-value: 0.412695% CI: [-2.82, 6.81]ANCOVA
Comparison: Comparison of end of treatment analysisp-value: 0.695995% CI: [-3.92, 5.85]ANCOVA
Secondary
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline
The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).
Time frame: Baseline
Population: Full analysis set with available ICIQ-SF QOL data at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline | 14.1 units on a scale | Standard Deviation 4.1 |
| Solifenacin Succinate | International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline | 13.8 units on a scale | Standard Deviation 4.11 |
Secondary
Percentage of Participants Who Gain Continence During 12-week Treatment Period
Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. End of treatment is the last on-treatment assessment during the treatment period.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set; the calculation of percentage of participants uses the full analysis set as the denominator at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Gain Continence During 12-week Treatment Period | Week 8 | 18.8 percentage of participants |
| Placebo | Percentage of Participants Who Gain Continence During 12-week Treatment Period | Week 4 | 10.4 percentage of participants |
| Placebo | Percentage of Participants Who Gain Continence During 12-week Treatment Period | Week 12 | 19.1 percentage of participants |
| Placebo | Percentage of Participants Who Gain Continence During 12-week Treatment Period | End of Treatment | 21.4 percentage of participants |
| Solifenacin Succinate | Percentage of Participants Who Gain Continence During 12-week Treatment Period | End of Treatment | 29.1 percentage of participants |
| Solifenacin Succinate | Percentage of Participants Who Gain Continence During 12-week Treatment Period | Week 12 | 26.5 percentage of participants |
| Solifenacin Succinate | Percentage of Participants Who Gain Continence During 12-week Treatment Period | Week 4 | 11.8 percentage of participants |
| Solifenacin Succinate | Percentage of Participants Who Gain Continence During 12-week Treatment Period | Week 8 | 21.1 percentage of participants |
Comparison: Comparison at Week 4p-value: 0.4833Cochran-Mantel-Haenszel
Comparison: Comparison at Week 8p-value: 0.5761Cochran-Mantel-Haenszel
Comparison: Comparison at Week 12p-value: 0.0592Cochran-Mantel-Haenszel
Comparison: Comparison of end of treatment analysisp-value: 0.039Cochran-Mantel-Haenszel
Secondary
Time From Baseline to First Day of Returning to Work
The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.
Time frame: From Baseline to Week 12
Population: Full analysis set participants who were employed prior to the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From Baseline to First Day of Returning to Work | 5.0 days |
| Solifenacin Succinate | Time From Baseline to First Day of Returning to Work | 5.0 days |
p-value: 0.27Log Rank