- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00852696
Over Active Bladder Patients Having Sling Surgery
June 8, 2022 updated by: Eric Hurtado, Cleveland Clinic Florida
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.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Weston, Florida, United States, 33331
- Cleveland Clinic Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Group
Placebo Orally 9 weeks once daily.
|
Take orally once daily for 9 weeks.
|
Experimental: Solifenacin Group
Solifenacin Orally 9 weeks once daily.
|
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 Names:
|
What is the study measuring?
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.
Time Frame: 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.
|
9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: G W Davila, MD, Cleeland Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
February 26, 2009
First Submitted That Met QC Criteria
February 26, 2009
First Posted (Estimate)
February 27, 2009
Study Record Updates
Last Update Posted (Actual)
July 1, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Solifenacin Succinate
- Tolterodine Tartrate
Other Study ID Numbers
- 8867 (CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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