Trial · NCT00573508
Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
NCT00573508, Phase 4, Completed, Astellas Pharma Inc; results first posted 2010-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life. Trials, record NCT00573508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00573508
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
- NCT number
- NCT00573508
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 768 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Placebo, Solifenacin Succinate
- First posted
- 2007-12-14
- Last updated
- 2010-10-05
- Results first posted
- 2010-10-05
- 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 outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Baseline and 12 Weeks | The OAB-q is used to assess how much a patient is bothered by OAB symptoms \& the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment - Baseline. |
| Secondary | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Baseline, Week 4, Week 8 and Week 12 | The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. Change is calculated as Actual Data for each timepoint - Baseline. |
| Secondary | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Baseline, Week 4, Week 8 and Week 12 | The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated as Actual Data for each time point - Baseline. |
| Secondary | Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) | Baseline and 12 Weeks | The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems Improvement is defined by any reduction in PPBC score. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline |
| Secondary | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Baseline and 12 Weeks | The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy. |
| Secondary | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Baseline, Week 4, Week 8 and Week 12 | The OAB-q is used to assess how much a patient is bothered by OAB symptoms \& the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated End of Treatment (EOT) for each sub-domain - Baseline. |
| Secondary | Change From Baseline in Work Productivity Assessment Index (WPAI) | Baseline and 12 Weeks | The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction \& quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions \& carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change from baseline is based on the ANCOVA model after adjusting baseline value \& center. |
| Secondary | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | Baseline and 12 Weeks | MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline |
| Secondary | Change From Baseline in the MCUI Behavior Therapy Stratified | Baseline and 12 Weeks | MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline |
| Secondary | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Baseline and 12 Weeks | ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction \& quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms \& impact on sexual quality of life, with a scale of 0 to 12. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Baseline and 12 Weeks | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants per arm is consistent for all categories / rows of the data table. | OAB-q Score | MEAN |
| SECONDARY | Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Baseline, Week 4, Week 8 and Week 12 | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | OAB-q Score | MEAN |
| SECONDARY | Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | Baseline, Week 4, Week 8 and Week 12 | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | OAB-q HRQL Total Score | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) | Baseline and 12 Weeks | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit. | Participants | NUMBER |
| SECONDARY | Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | Baseline and 12 Weeks | The number assessed included all participants who completed the BSW questionnaire at baseline visit (visit 2) and end of treatment (visit 5/early withdrawal).~A few patients who completed the BSW Questionnaire did not adequately complete the Benefits Section and therefore are considered 'N/A' for that Section. | Participants | NUMBER |
| SECONDARY | Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | Baseline, Week 4, Week 8 and Week 12 | Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~Number of participants analyzed per arm represents FAS. The numbers of participants for each visit/sub domain are noted in the category titles. | OAB-q HRQL Sub Domain Score | MEAN |
| SECONDARY | Change From Baseline in Work Productivity Assessment Index (WPAI) | Baseline and 12 Weeks | Population is full analysis set (FAS): all randomized patients who took at least 1 dose of double-blind study drug \& had an OAB-q assessment at both baseline \& at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint / parameter are noted in the category titles. | Percentage of indicated parameter | MEAN |
| SECONDARY | Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | Baseline and 12 Weeks | Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication \& had an assessment in OAB-q at both baseline \& at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles. | Number of categorical items | MEAN |
| SECONDARY | Change From Baseline in the MCUI Behavior Therapy Stratified | Baseline and 12 Weeks | Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication \& had an assessment in OAB-q at both baseline \& at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles. | Number of Days | MEAN |
| SECONDARY | Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores. | Baseline and 12 Weeks | Population is full analysis set(FAS): all randomized male patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | ICIQ-MLUTSsex | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group230
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Placebo | Baseline | 57.9 | Standard Deviation 18.18 | OAB-q Score |
| Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Solifenacin Succinate | Baseline | 58.2 | Standard Deviation 18.75 | OAB-q Score |
| Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Placebo | End of Treatment | 37.5 | Standard Deviation 22.54 | OAB-q Score |
| Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Solifenacin Succinate | End of Treatment | 28.3 | Standard Deviation 20.36 | OAB-q Score |
| Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Placebo | Change at End of Treatment | -20.4 | Standard Deviation 21.72 | OAB-q Score |
| Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | Solifenacin Succinate | Change at End of Treatment | -29.9 | Standard Deviation 22.64 | OAB-q Score |
| Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Placebo | Baseline ( N= 374 ; 377) | 57.9 | Standard Deviation 18.18 | OAB-q Score |
| Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Solifenacin Succinate | Baseline ( N= 374 ; 377) | 58.2 | Standard Deviation 18.75 | OAB-q Score |
| Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Placebo | Week 4 (N=371; 370) | 41.6 | Standard Deviation 21.04 | OAB-q Score |
| Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | Solifenacin Succinate | Week 4 (N=371; 370) | 35.5 | Standard Deviation 20.77 | OAB-q Score |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 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 | 382 | |
| Overall Study | STARTED | Solifenacin Succinate | 386 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 374 | |
| Overall Study | Full Analysis Set (FAS) | Solifenacin Succinate | 377 | |
| Overall Study | COMPLETED | Placebo | 318 | |
| Overall Study | COMPLETED | Solifenacin Succinate | 345 | |
| Overall Study | NOT COMPLETED | Placebo | 64 | |
| Overall Study | NOT COMPLETED | Solifenacin Succinate | 41 |
Source ClinicalTrials.gov
Adverse events40
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 | Constipation | Gastrointestinal disorders | Placebo | 9 | 382 | |
| other | Constipation | Gastrointestinal disorders | Solifenacin Succinate | 32 | 386 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 9 | 382 | |
| other | Dry Mouth | Gastrointestinal disorders | Solifenacin Succinate | 52 | 386 | |
| serious | Atrial Fibrillation | Cardiac disorders | Placebo | 1 | 382 | |
| serious | Atrial Fibrillation | Cardiac disorders | Solifenacin Succinate | 0 | 386 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 382 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Solifenacin Succinate | 1 | 386 | |
| serious | Abdominal Strangulated Hernia | Gastrointestinal disorders | Placebo | 0 | 382 | |
| serious | Abdominal Strangulated Hernia | Gastrointestinal disorders | Solifenacin Succinate | 1 | 386 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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 | 18 | 382 |
| Total, other adverse events | Solifenacin Succinate | 84 | 386 |
| Total, serious adverse events | Placebo | 6 | 382 |
| Total, serious adverse events | Solifenacin Succinate | 3 | 386 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT00573508
GET https://conductscience.org/api/trials/v1/NCT00573508/results?page=2