The Effect of Solifenacin on Post Void Dribbling in Women

Study Overview
=================
Brief 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.

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

Official Title
-----------------
The Effect of Solifenacin on Post Void Dribbling in Women: A Randomized Controlled Multicenter Trial

Conditions
-----------------
Incontinence, Post-micturition Incontinence

Intervention / Treatment
-----------------
* Drug: solifenacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between the ages of 18 and 89 Incontinence in the form of post void dribbling that occurs at least twice weekly. Exclusion Criteria: 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: solifenacin<br>patients in this arm will receive drug | Drug: solifenacin<br>* patient will receive solifenacin 5mg daily or placebo daily<br>* Other names: vesicare;|
| Placebo Comparator: placebo<br>patients is this arm will receive placebo | Drug: solifenacin<br>* patient will receive solifenacin 5mg daily or placebo daily<br>* Other names: vesicare;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percent Reduction in Post Void Dribbling Episodes (Events) |  | outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes |  | 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). | outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment |