Over Active Bladder Patients Having Sling Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.

Detailed Description
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Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.

Official Title
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A Double Blind, Randomized Placebo Controlled Trial of the Perioperative Use of Solifenacin in the Management of Postoperative Overactive Bladder Symptoms in Patients With Mixed Incontinence Undergoing Suburethral Sling Procedures.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Solifenacin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 18 Patient is appropriate for sub-urethral sling procedure Mixed urinary incontinence No antimuscarinic therapy for previous 30 days Exclusion Criteria: Uncontrolled narrow angle glaucoma Acute cystitis Unevaluated hematuria Currently using anti-muscarinic therapy Unable to complete pre-operative urodynamics Contraindication to anti-cholinergic therapy Unable or unwilling to complete diaries or quality of life questionaire Significant (exteriorized) Pelvic Organ Prolapse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Placebo Orally 9 weeks once daily. | Other: Placebo<br>* Take orally once daily for 9 weeks.<br>|
| Experimental: Solifenacin Group<br>Solifenacin Orally 9 weeks once daily. | Drug: Solifenacin<br>* Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks.<br>* Other names: Tolterodine Tartrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine Whether Treatment With Anti-muscarinic Medications Following Sub-urethral Sling Procedures Improves Overall Subjective and Objective Outcomes in Women With Mixed Incontinence With Primary Stress Symptoms. | Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks. | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Incontinence, Solifenacin, Women, Postoperative