BOTOX® at the Time of Prolapse Surgery for OAB

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed National Military Medical Center
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

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