Urinary IncontinencePhase 4NCT01371994
A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
A Phase 4 study testing solifenacin succinate in people with Urinary Incontinence, run by Astellas Pharma Inc at 60 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- solifenacin succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 60 sitesin 2 countries
- Study dates
- 2 Aug 2011to 21 Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
60 sites in 2 countries.
60 sites in 2 countries
United States58 sites
Community Care Physicians PC
Albany, New York, 12208
Alaska Clinical Research Center
Anchorage, Alaska, 99508
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Brooklyn Urology Research Group
Brooklyn, New York, 11215
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Cary Urology
Cary, North Carolina, 27511
CAMC Institute Clinical Trial Center
Charleston, West Virginia, 25304
Academic Urologists
Chattanooga, Tennessee, 37403
Northwestern University
Chicago, Illinois, 60611
The Urology Group
Cincinnati, Ohio, 45212
Cleveland Clinic
Cleveland, Ohio, 44195
Urology Clinics of North Texas
Dallas, Texas, 75231
Urology Center of Colorado
Denver, Colorado, 80211
Henry Ford Hospital
Detroit, Michigan, 48202
Pharma Resources
East Providence, Rhode Island, 02915
Urology Associates
Englewood, Colorado, 80113
Northeast Indiana Research
Fort Wayne, Indiana, 46825
University of Florida
Gainesville, Florida, 32610
Spectrum Health Medical Group
Grand Rapids, Michigan, 49546
Urology of Indiana
Greenwood, Indiana, 46143
Urology Research Network
Hialeah, Florida, 33016
Urology Centers of Alabama
Homewood, Alabama, 35209
Methodist Hospital Research Institute
Houston, Texas, 77030
Methodist Urology Associates
Houston, Texas, 77094
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
East Coast Institute for Research
Jacksonville, Florida, 32204
Volunteer Research Group
Knoxville, Tennessee, 37920
University of California, San Diego Moores Cancer Center
La Jolla, California, 92093
South Nevada Aids Research
Las Vegas, Nevada, 89106
AdvanceMed Research
Lawrenceville, New Jersey, 08648
Tower Urology
Los Angeles, California, 90048
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Southeast Urology Network
Memphis, Tennessee, 38119
Connecticut Clinical Research Center
Middlebury, Connecticut, 06762
Five Valley Urology
Missoula, Montana, 59808
Delaware Valley Urology
Mount Laurel, New Jersey, 08043
Grove Hill Medical Center
New Britain, Connecticut, 06052
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Tulane University School of Medicine, Department of Urology
New Orleans, Louisiana, 70112
University Urology Associates
New York, New York, 10016
Winter Park Urology Associates
Orlando, Florida, 32803
Advanced Urology
Parker, Colorado, 80134
Oregon Health and Science University
Portland, Oregon, 97239
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601
Associated Urologists of North Carolina
Raleigh, North Carolina, 27607
University of Rochester Medical Center
Rochester, New York, 14642
Radiological Associates of Sacramento Medical Group, Inc.
Sacramento, California, 95815
Urology San Antonio Research
San Antonio, Texas, 78229
Adult and Pediatric Urology Group
Sartell, Minnesota, 56377
Virginia Mason Medical Center
Seattle, Washington, 98101
Swedish Urology Group
Seattle, Washington, 98104
Springfield Clinic
Springfield, Illinois, 62703
AMP Urology
Syracuse, New York, 13210
Southeastern Research Group
Tallahassee, Florida, 32308
Romius Institute of Northwest Ohio
Toledo, Ohio, 43615
Urological Associates of Southern Arizona
Tucson, Arizona, 85715
Urologic Surgeons of Washington
Washington D.C., District of Columbia, 20036
The Iowa Clinic
West Des Moines, Iowa, 50266
Canada2 sites
University Health Network/ Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
The Prostate Centre, Diamond Health Care Centre
Vancouver, British Columbia, V5Z IM9
About this study
Official title: A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- solifenacin succinate, Placebo
- Keywords
- Radical Robotic Arm, Vesicare, Post Prostatectomy Incontinence, YM905
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacin succinateDrug
Also called Vesicare, YM905
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin succinate | Experimental | 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. Receives: Drug: solifenacin succinate |
| Placebo | Placebo comparator | Participants received matching placebo tablets once a day for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (18)
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.
Measured: Weeks 4, 8, and 12
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.
Measured: Baseline (7 days prior to Day 1)
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.
Measured: Baseline and Weeks 4, 8 and 12
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).
Measured: Baseline
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.
Measured: Baseline and Week 12
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).
Measured: Baseline
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.
Measured: Baseline and Week 12
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).
Measured: Baseline
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).
Measured: Baseline and Week 12
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.
Measured: Baseline
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.
Measured: Baseline and Week 12
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.
Measured: Baseline
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.
Measured: Baseline and Week 12
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.
Measured: Baseline
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.
Measured: Baseline and Week 12
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.
Measured: Baseline
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.
Measured: Baseline and Week 12
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.
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study start2 Aug 2011
- Primary completion21 Oct 2013
- Study completion21 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371994
- Sponsor's protocol ID
- 905-UC-050
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2011
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01371994
- Acronym / sponsor ID
- 905-UC-050
- Conditions
- Urinary Incontinence
- Keywords
- Radical Robotic Arm, Vesicare, Post Prostatectomy Incontinence, YM905
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2011 (actual)
- Primary completion
- 21 Oct 2013 (actual)
- Study completion
- 21 Oct 2013 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 9 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solifenacin succinate | Experimental | Drug: solifenacin succinateParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo tablets once a day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solifenacin succinateAlso: Vesicare, YM905oral | Drug | Solifenacin succinate |
| Placebooral | Drug | Placebo |
Primary outcome
Time From First Dose to Urinary Continence
Time frame: 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.
18 secondary outcomes
Percentage of Participants Who Gain Continence During 12-week Treatment Period
Time frame: Weeks 4, 8, and 12
Average Daily Pad Usage at Baseline
Time frame: Baseline (7 days prior to Day 1)
Change From Baseline in Average Daily Pad Usage
Time frame: Baseline and Weeks 4, 8 and 12
American Urology Association Symptom Score (AUASS) at Baseline
Time frame: Baseline
Change From Baseline in American Urology Association Symptom Score (AUASS)
Time frame: Baseline and Week 12
American Urology Association Quality of Life (QOL) Score at Baseline
Time frame: Baseline
Change From Baseline in American Urology Association Quality of Life (QOL) Score
Time frame: Baseline and Week 12
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline
Time frame: Baseline
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score
Time frame: Baseline and Week 12
Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Time frame: Baseline
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed
Time frame: Baseline and Week 12
Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working
Time frame: Baseline
Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working
Time frame: Baseline and Week 12
Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Time frame: Baseline
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment
Time frame: Baseline and Week 12
Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Time frame: Baseline
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment
Time frame: Baseline and Week 12
Time From Baseline to First Day of Returning to Work
Time frame: From Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development
60 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing solifenacin succinate in people with Urinary Incontinence, run by Astellas Pharma Inc at 60 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From First Dose to Urinary Continence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.