Trial Outcomes & Findings for A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy (NCT NCT01371994)

NCT ID: NCT01371994

Last Updated: 2024-11-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 640 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-11-21

Participant Flow

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.

Participants meeting the Baseline criteria were randomized 1:1 to 5 mg solifenacin succinate or matching placebo.

Participant milestones

Measure	Placebo Participants received matching placebo tablets once a day for 12 weeks.	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.
Overall Study STARTED	320	320
Overall Study Received Treatment	310	313
Overall Study COMPLETED	263	278
Overall Study NOT COMPLETED	57	42

Reasons for withdrawal

Measure	Placebo Participants received matching placebo tablets once a day for 12 weeks.	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.
Overall Study Adverse Event	3	6
Overall Study Lack of Efficacy	3	0
Overall Study Withdrawal by Subject	13	7
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	24	17
Overall Study Randomized but Never Received Study Drug	6	6
Overall Study Physician Decision	1	1
Overall Study Miscellaneous Reasons	6	4

Baseline Characteristics

A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy

Baseline characteristics by cohort

Measure	Placebo n=310 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=313 Participants 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.	Total n=623 Participants Total of all reporting groups
Age, Continuous	61.2 years STANDARD_DEVIATION 6.72 • n=5 Participants	60.5 years STANDARD_DEVIATION 7.21 • n=7 Participants	60.9 years STANDARD_DEVIATION 6.98 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	310 Participants n=5 Participants	313 Participants n=7 Participants	623 Participants n=5 Participants
Race/Ethnicity, Customized White	263 participants n=5 Participants	266 participants n=7 Participants	529 participants n=5 Participants
Race/Ethnicity, Customized Black	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	284 participants n=5 Participants	284 participants n=7 Participants	568 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 participants n=5 Participants	29 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=309 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=313 Participants 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.
Time From First Dose to Urinary Continence	NA days Interval 93.0 to Data were not observed during 12-week treatment period due to low incidence of continence events.	NA days Data were not observed during 12-week treatment period due to low incidence of continence events.

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=309 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=313 Participants 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.
Percentage of Participants Who Gain Continence During 12-week Treatment Period Week 4	10.4 percentage of participants	11.8 percentage of participants
Percentage of Participants Who Gain Continence During 12-week Treatment Period Week 8	18.8 percentage of participants	21.1 percentage of participants
Percentage of Participants Who Gain Continence During 12-week Treatment Period Week 12	19.1 percentage of participants	26.5 percentage of participants
Percentage of Participants Who Gain Continence During 12-week Treatment Period End of Treatment	21.4 percentage of participants	29.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline (7 days prior to Day 1)

Population: Full analysis set with available pad usage data 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.

Outcome measures

Measure	Placebo n=309 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=313 Participants 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.
Average Daily Pad Usage at Baseline	5.0 pads Standard Deviation 2.30	4.7 pads Standard Deviation 2.16

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=298 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=302 Participants 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.
Change From Baseline in Average Daily Pad Usage Week 4 (n=297, 302)	-1.9 pads Standard Error 0.10	-2.0 pads Standard Error 0.09
Change From Baseline in Average Daily Pad Usage Week 8 (n=280, 292)	-2.5 pads Standard Error 0.10	-2.8 pads Standard Error 0.10
Change From Baseline in Average Daily Pad Usage Week 12 (n=226, 226)	-3.1 pads Standard Error 0.10	-3.4 pads Standard Error 0.10
Change From Baseline in Average Daily Pad Usage End of treatment (n=298, 302)	-2.9 pads Standard Error 0.09	-3.2 pads Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set with available AUASS data 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).

Outcome measures

Measure	Placebo n=306 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=311 Participants 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.
American Urology Association Symptom Score (AUASS) at Baseline	16.7 units on a scale Standard Deviation 7.07	16.2 units on a scale Standard Deviation 7.22

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=293 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=307 Participants 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.
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	-8.0 units on a scale Standard Error 0.32
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	-7.7 units on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set with available AUA QOL data 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).

Outcome measures

Measure	Placebo n=306 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=310 Participants 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.
American Urology Association Quality of Life (QOL) Score at Baseline	4.8 units on a scale Standard Deviation 1.22	4.7 units on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=292 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=306 Participants 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.
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 0.10	-2.1 units on a scale Standard Error 0.10
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	-2.0 units on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set with available ICIQ-SF QOL data 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).

Outcome measures

Measure	Placebo n=306 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=311 Participants 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.
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline	14.1 units on a scale Standard Deviation 4.10	13.8 units on a scale Standard Deviation 4.11

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Placebo n=292 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=307 Participants 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.
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	-6.2 units on a scale Standard Error 0.25
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	-6.0 units on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set participants who were employed prior to the study and with available WPAI data at 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.

Outcome measures

Measure	Placebo n=96 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=112 Participants 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.
Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed	43.6 percent work time missed Standard Deviation 46.22	37.9 percent work time missed Standard Deviation 45.50

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=88 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=102 Participants 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.
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	-37.6 Percent work time missed Standard Error 1.42
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	-34.4 Percent work time missed Standard Error 2.04

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set participants who were employed prior to the study and with available WPAI data at 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.

Outcome measures

Measure	Placebo n=75 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=101 Participants 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.
Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working	35.5 percent impairment while working Standard Deviation 30.05	34.1 percent impairment while working Standard Deviation 29.70

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=72 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=91 Participants 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.
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	-23.8 percent impairment while working Standard Error 1.71
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	-21.8 percent impairment while working Standard Error 1.72

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set participants who were employed prior to the study and with available WPAI data at 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.

Outcome measures

Measure	Placebo n=69 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=89 Participants 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.
Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment	42.5 percent overall work impairment Standard Deviation 35.26	44.8 percent overall work impairment Standard Deviation 33.41

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=65 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=79 Participants 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.
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	-33.7 percent overall work impairment Standard Error 1.94
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	-31.1 percent overall work impairment Standard Error 1.95

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set participants with available WPAI data at 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.

Outcome measures

Measure	Placebo n=127 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=147 Participants 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.
Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment	41.6 percent activity impairment Standard Deviation 28.38	41.4 percent activity impairment Standard Deviation 27.49

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=124 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=145 Participants 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.
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	-30.2 Percent activity impairment Standard Error 1.82
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	-28.8 Percent activity impairment Standard Error 1.78

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Full analysis set participants who were employed prior to the study.

The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Placebo n=127 Participants Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=147 Participants 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.
Time From Baseline to First Day of Returning to Work	5.0 days Interval 4.0 to 12.0	5.0 days Interval 3.0 to 8.0

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Solifenacin Succinate

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=310 participants at risk Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=313 participants at risk 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.
Cardiac disorders Acute Coronary Syndrome	0.32% 1/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.00% 0/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Gastrointestinal disorders Dry Mouth	0.00% 0/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.32% 1/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Hepatobiliary disorders Cholecystitis	0.00% 0/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.32% 1/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Infections and infestations Arthritis Bacterial	0.00% 0/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.32% 1/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Infections and infestations Cellulitis	0.32% 1/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.00% 0/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Infections and infestations Infected Lymphocele	0.00% 0/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.32% 1/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Infections and infestations Psoas Abscess	0.32% 1/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.00% 0/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Recurrent	0.00% 0/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.32% 1/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Nervous system disorders Convulsion	0.32% 1/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.00% 0/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Renal and urinary disorders Renal Failure	0.32% 1/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.00% 0/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.32% 1/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.32% 1/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Vascular disorders Lymphocele	0.00% 0/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	0.64% 2/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).

Other adverse events

Measure	Placebo n=310 participants at risk Participants received matching placebo tablets once a day for 12 weeks.	Solifenacin Succinate n=313 participants at risk 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.
Gastrointestinal disorders Dry mouth	0.65% 2/310 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).	6.1% 19/313 • From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).

Additional Information

Medical Director, Urology

Astellas Pharma Global Development, Inc.

Email: clinicaltrials@us.astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data, or 18 months after data lock, whichever occurs first. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication for up to 60 days to seek patent protection.
• Publication restrictions are in place

Restriction type: OTHER