Over Active Bladder Patients Having Sling Surgery

Overactive Bladder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00852696
• Other study ID #: 8867
• Status: Terminated
• Phase: N/A
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: June 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin
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.

Other:
• Placebo
Take orally once daily for 9 weeks.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cleveland Clinic Florida	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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