Post-micturition IncontinenceNCT01470001
The Effect of Solifenacin on Post Void Dribbling in Women
A study testing solifenacin in people with Post-micturition Incontinence and Incontinence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-micturition Incontinence, Incontinence
- What is being tested?
- solifenacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Sep 2015
- Phase
- Interventional
- 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 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between the ages of 18 and 89
- Incontinence in the form of post void dribbling that occurs at least twice weekly.
Who cannot join
- Severe renal or hepatic disease.
- Active urinary tract infection.
- Glaucoma.
- Stress incontinence as the only incontinence symptom
- Urge incontinence as the only incontinence symptom
- Chronic severe constipation.
Show all 12Show fewer
- History of bladder cancer.
- Known or suspected hypersensitivity to anticholinergics.
- Any clinical condition that would not allow safe completion of the study.
- Pregnancy or lactation, intention to become pregnant during the study, or use of an unreliable birth control method in women of childbearing potential. Reliable forms of contraception include: permanent sterilization of either partner, hormonal contraception (oral contraceptive, Nuva ring, contraceptive patch, depoprovera, implants), intrauterine device (IUD), and condoms. Abstinence is considered a reliable form of contraception, but abstinent subjects will be informed that they need to use condoms or other form of birth control mentioned above if they become sexually active during the study.
- Presently on systemic anti-cholinergic therapy or who have been on therapy within the last 4 weeks. Anti-cholinergic drugs include; darifenacin, fesoterodine, hyoscyamine, oxybutynin, solifenacin, tolterodine, and trospium.
- Solid forms of potassium supplementation, as this presents an increased risk of GI side effects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial
This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.
Read the detailed description
This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint.
Secondary endpoints will include:
- The % of patients with at least a 50% reduction in post void dribbling episodes.
- Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary symptoms and quality of life.
We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators
- Conditions
- Post-micturition Incontinence, Incontinence
- Being tested
- solifenacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacinDrug
Also called vesicare
patient will receive solifenacin 5mg daily or placebo daily
| Study group | Role | What they receive |
|---|---|---|
| solifenacin | Active comparator | patients in this arm will receive drug Receives: Drug: solifenacin |
| placebo | Placebo comparator | patients is this arm will receive placebo Receives: Drug: solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent Reduction in Post Void Dribbling Episodes (Events)
Measured: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12
Secondary outcomes (2)
the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes
Measured: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12
Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)
The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect.
The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease).
Measured: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2015
- Study completionSep 2015
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 Post-micturition IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tova S Ablove, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470001
- Sponsor's protocol ID
- 2011-0513
- Status last verified
- Jul 2017
- First submitted
- 2 Nov 2011
- Last updated
- 23 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT01470001
- Acronym / sponsor ID
- 2011-0513
- Conditions
- Post-micturition Incontinence, Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Posted 23 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.
Detailed description
This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint.
Secondary endpoints will include:
- The % of patients with at least a 50% reduction in post void dribbling episodes.
- Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary symptoms and quality of life.
We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solifenacin | Active comparator | Drug: solifenacinpatients in this arm will receive drug |
| placebo | Placebo comparator | Drug: solifenacinpatients is this arm will receive placebo |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women between the ages of 18 and 89
- Incontinence in the form of post void dribbling that occurs at least twice weekly.
Key exclusion criteria (12 listed)
- Severe renal or hepatic disease.
- Active urinary tract infection.
- Glaucoma.
- Stress incontinence as the only incontinence symptom
- Urge incontinence as the only incontinence symptom
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 |
|---|---|---|
| solifenacinAlso: vesicarepatient will receive solifenacin 5mg daily or placebo daily | Drug | placebo, solifenacin |
Primary outcome
The Percent Reduction in Post Void Dribbling Episodes (Events)
Time frame: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12
2 secondary outcomes
the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes
Time frame: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12
Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)
Time frame: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tova S Ablove, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing solifenacin in people with Post-micturition Incontinence and Incontinence, run by University of Wisconsin, Madison at 1 site in United States.
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 2 inclusion and 12 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 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2017). 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?
The Percent Reduction in Post Void Dribbling Episodes (Events) (time frame: outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12). 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 23 Aug 2017.