Over Active Bladder Patients Having Sling Surgery

Not Applicable

Terminated

• Conditions: Overactive Bladder
• Interventions: Other: Placebo; Drug: Solifenacin

• Registration Number: NCT00852696
• Lead Sponsor: Cleveland Clinic Florida

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Primary Completion: 2009-07
• Study Completion: 2010-02
• Results First Submitted: 2019-02-27
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Results First Posted: 2022-07-01
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Placebo Orally 9 weeks once daily.
Solifenacin Group	Solifenacin	Solifenacin Orally 9 weeks once daily.

Primary Outcome Measures

Name	Time	Method
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.	9 weeks	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.

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States