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BOTOX® at the Time of Prolapse Surgery for OAB

NCT04807920 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2021-10-14

No results posted yet for this study

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.

Conditions

  • Urinary Bladder, Overactive
  • Pelvic Organ Prolapse

Interventions

DRUG

OnabotulinumtoxinA 100 UNT

Intravesical injection

OTHER

Injectable saline

Intravesical injection

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04807920 on ClinicalTrials.gov