Pelvic Organ Prolapse Clinical Trial
Official title:
Intravesical OnabotulinumtoxinA Injection at the Time of Prolapse Surgery for the Treatment of Overactive Bladder Syndrome: a Randomized Controlled Trial
The purpose of the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women scheduled for prolapse surgery - Bothersome OAB symptoms determined by a score of >20 on the OAB-q SF - Willingness to perform clean intermittent catheterization (CIC) - Ability to follow study instructions and complete required follow up Exclusion Criteria: - Contraindications or allergy to Onabotulinumtoxin A - Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date - Total body Onabotulinumtoxin A dose of = 400 Units in the 3 months prior to the scheduled surgery date. - Inability or unwillingness to self-catheterize - Post-void residual = 200mL - Neurogenic bladder or other neurological diseases that may cause voiding dysfunction - Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery. - Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study. - Inability to speak or read English |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Walter Reed National Military Medical Center |
United States,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference. | The OAB-q SF is a validated 6 item questionnaire that is scored and reported on a 0 to 100 point scale with increasing scores indicating more bother. | From baseline (time of enrollment) to 6-12 weeks postoperatively | |
Secondary | Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12). | The PISQ-12 is a 12 item validated questionnaire that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. It is reported on a scale of 0-48, with a higher score indicating worse sexual function. | From baseline (time of enrollment) to 6-12 weeks postoperatively | |
Secondary | Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S). | The PGI-S is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating greater severity. | From baseline (time of enrollment) to 6-12 weeks postoperatively | |
Secondary | Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively. | The PGI-I is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating less improvement. | At 6-12 weeks postoperatively | |
Secondary | Urinary tract infection | Rate of urinary tract infections based on clinical suspicion and urine culture results | From time of treatment to 12 weeks postoperative | |
Secondary | Urinary retention | Rate of urinary retention requiring catheterization, defined as a post-void residual of more than 400mL or 200-400mL with symptoms of incomplete bladder emptying. | From 2 weeks postoperatively to 12 weeks postoperatively |
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