BOTOX® at the Time of Prolapse Surgery for OAB

Study Overview
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Brief Summary
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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.

Detailed Description
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After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.

Official Title
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Intravesical OnabotulinumtoxinA Injection at the Time of Prolapse Surgery for the Treatment of Overactive Bladder Syndrome: a Randomized Controlled Trial

Conditions
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Urinary Bladder, Overactive, Pelvic Organ Prolapse

Intervention / Treatment
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* Drug: OnabotulinumtoxinA 100 UNT
* Other: Injectable saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravesical OnabotulinumtoxinA<br>The treatment group will receive 100 units of BOTOX® reconstituted in 10mL of injectable preservative-free normal saline at the time of cystoscopy. An injection cystoscopy needle will be set to 3mm and used to inject 0.5mL reconstituted OnabotulinumtoxinA at each injection site, approximately 1cm apart along the posterior bladder wall, for a total of 20 injection sites (4 rows of 5 injection sites). This will be the only treatment. | Drug: OnabotulinumtoxinA 100 UNT<br>* Intravesical injection<br>|
| Placebo Comparator: Placebo<br>Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment. | Other: Injectable saline<br>* Intravesical injection<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Urinary tract infection | Rate of urinary tract infections based on clinical suspicion and urine culture results | From time of treatment to 12 weeks postoperative | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum Toxins, Type A, Mixed Urinary Incontinence, Urgency urinary incontinence