Back to resultsOver Active Bladder Patients Having Sling Surgery
Primary Purpose
Overactive Bladder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Solifenacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Incontinence, Solifenacin, Women, Postoperative
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo Group
Solifenacin Group
Arm Description
Placebo Orally 9 weeks once daily.
Solifenacin Orally 9 weeks once daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00852696
First Posted
February 26, 2009
Last Updated
June 8, 2022
Sponsor
Cleveland Clinic Florida
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00852696
Brief Title
Over Active Bladder Patients Having Sling Surgery
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Investigator left Cleveland Clinic and absolutely no data is available.
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cleveland Clinic Florida
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, Incontinence, Solifenacin, Women, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo Orally 9 weeks once daily.
Arm Title
Solifenacin Group
Arm Type
Experimental
Arm Description
Solifenacin Orally 9 weeks once daily.
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Other Intervention Name(s)
Tolterodine Tartrate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Take orally once daily for 9 weeks.
Primary Outcome Measure Information:
Title
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.
Time Frame
9 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G W Davila, MD
Organizational Affiliation
Cleeland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Over Active Bladder Patients Having Sling Surgery
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