Trial · NCT01371994
A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
NCT01371994, Phase 4, Completed, Astellas Pharma Inc; results first posted 2014-10-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy. Trials, record NCT01371994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01371994
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
- NCT number
- NCT01371994
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 640 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Urinary Incontinence
- Interventions
- solifenacin succinate, Placebo
- First posted
- 2011-06-13
- Last updated
- 2024-11-21
- Results first posted
- 2014-10-09
- Limitations and caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From First Dose to Urinary Continence | 12 weeks | 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. | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Gain Continence During 12-week Treatment Period | Weeks 4, 8, and 12 | Full analysis set; the calculation of percentage of participants uses the full analysis set as the denominator at each time point. | percentage of participants | NUMBER |
| SECONDARY | Average Daily Pad Usage at Baseline | Baseline (7 days prior to Day 1) | Full analysis set with available pad usage data at Baseline. | pads | MEAN |
| SECONDARY | Change From Baseline in Average Daily Pad Usage | Baseline and Weeks 4, 8 and 12 | 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. | pads | LEAST_SQUARES_MEAN |
| SECONDARY | American Urology Association Symptom Score (AUASS) at Baseline | Baseline | Full analysis set with available AUASS data at Baseline. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in American Urology Association Symptom Score (AUASS) | Baseline and Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | American Urology Association Quality of Life (QOL) Score at Baseline | Baseline | Full analysis set with available AUA QOL data at Baseline. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in American Urology Association Quality of Life (QOL) Score | Baseline and Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline | Baseline | Full analysis set with available ICIQ-SF QOL data at Baseline. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score | Baseline and Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From First Dose to Urinary Continence | Placebo | NA | 95% Confidence Interval 93.0 to NA | days | |
| Time From First Dose to Urinary Continence | Solifenacin Succinate | NA | 95% Confidence Interval NA to NA | days | |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Placebo | Week 4 | 10.4 | percentage of participants | |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Solifenacin Succinate | Week 4 | 11.8 | percentage of participants | |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Placebo | Week 8 | 18.8 | percentage of participants | |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Solifenacin Succinate | Week 8 | 21.1 | percentage of participants | |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Placebo | Week 12 | 19.1 | percentage of participants | |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Solifenacin Succinate | Week 12 | 26.5 | percentage of participants | |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Placebo | End of Treatment | 21.4 | percentage of participants | |
| Percentage of Participants Who Gain Continence During 12-week Treatment Period | Solifenacin Succinate | End of Treatment | 29.1 | percentage of participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 320 | |
| Overall Study | STARTED | Solifenacin Succinate | 320 | |
| Overall Study | Received Treatment | Placebo | 310 | |
| Overall Study | Received Treatment | Solifenacin Succinate | 313 | |
| Overall Study | COMPLETED | Placebo | 263 | |
| Overall Study | COMPLETED | Solifenacin Succinate | 278 | |
| Overall Study | NOT COMPLETED | Placebo | 57 | |
| Overall Study | NOT COMPLETED | Solifenacin Succinate | 42 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Placebo | 2 | 310 | |
| other | Dry mouth | Gastrointestinal disorders | Solifenacin Succinate | 19 | 313 | |
| serious | Acute Coronary Syndrome | Cardiac disorders | Placebo | 1 | 310 | |
| serious | Acute Coronary Syndrome | Cardiac disorders | Solifenacin Succinate | 0 | 313 | |
| serious | Dry Mouth | Gastrointestinal disorders | Placebo | 0 | 310 | |
| serious | Dry Mouth | Gastrointestinal disorders | Solifenacin Succinate | 1 | 313 | |
| serious | Cholecystitis | Hepatobiliary disorders | Placebo | 0 | 310 | |
| serious | Cholecystitis | Hepatobiliary disorders | Solifenacin Succinate | 1 | 313 | |
| serious | Arthritis Bacterial | Infections and infestations | Placebo | 0 | 310 | |
| serious | Arthritis Bacterial | Infections and infestations | Solifenacin Succinate | 1 | 313 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Solifenacin Succinate | ||
| Total, other adverse events | Placebo | 2 | 310 |
| Total, other adverse events | Solifenacin Succinate | 19 | 313 |
| Total, serious adverse events | Placebo | 5 | 310 |
| Total, serious adverse events | Solifenacin Succinate | 7 | 313 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Solifenacin Succinate vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01371994
GET https://conductscience.org/api/trials/v1/NCT01371994/results?page=2