Overactive Bladder
Conditions
Keywords
Overactive Bladder, Incontinence, Solifenacin, Women, Postoperative
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.
Interventions
DRUGSolifenacin
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.
OTHERPlacebo
Take orally once daily for 9 weeks.
Sponsors
Astellas Pharma US, Inc.
Cleveland Clinic Florida
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment completed in a clinic setting for eligible participants.
Pre-assignment details
1 subject enrolled, unknown patient assignment because this study was double blinded. To our knowledge, the participant never started this trial and no data was collected as study was terminated.
Participants by arm
| Arm | Count |
|---|---|
| Solifenacin Group Solifenacin Orally 9 weeks once daily.
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. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: 9 weeks
Population: Principal investigator left the institution, no data is available.~1 subject enrolled, unknown patient assignment because this study was double blinded. Data was never collected for this study.