Status:
UNKNOWN
BOTOX® at the Time of Prolapse Surgery for OAB
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Urinary Bladder, Overactive
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04807920
Start Date
September 23 2021
End Date
June 1 2023
Last Update
October 14 2021
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-560