Urinary Bladder, Overactive, Pelvic Organ Prolapse
Conditions
Keywords
Botulinum Toxins, Type A, Mixed Urinary Incontinence, Urgency urinary incontinence
Brief summary
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
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.
Interventions
Intravesical injection
OTHERInjectable saline
Intravesical injection
Sponsors
Walter Reed National Military Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From baseline (time of enrollment) to 6-12 weeks postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12). | From baseline (time of enrollment) to 6-12 weeks postoperatively | 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. |
| Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S). | From baseline (time of enrollment) to 6-12 weeks postoperatively | The PGI-S is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating greater severity. |
| Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively. | At 6-12 weeks postoperatively | The PGI-I is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating less improvement. |
| Urinary tract infection | From time of treatment to 12 weeks postoperative | Rate of urinary tract infections based on clinical suspicion and urine culture results |
| Urinary retention | From 2 weeks postoperatively to 12 weeks postoperatively | 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. |
Countries
United States
Contacts
Primary ContactJoy E Wheat, MD
Backup ContactChristine Vaccaro, DO
Outcome results
None listed