BOTOX at the Time of Prolapse Surgery for OAB

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    138
  • sponsor
    Walter Reed National Military Medical Center
Updated on 22 October 2021
brimonidine tartrate ophthalmic solution
botox
urinary urgency
onabotulinumtoxina
intravesical injections
bladder symptoms
intermittent catheterization

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.

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.

Details
Condition Ptosis, Vaginal Vault Prolapse, Genitourinary Prolapse, Overactive Bladder, pelvic organ prolapse
Treatment OnabotulinumtoxinA 100 UNT, injectable saline
Clinical Study IdentifierNCT04807920
SponsorWalter Reed National Military Medical Center
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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