BOTOX® at the Time of Prolapse Surgery for OAB

October 5, 2021 updated by: Walter Reed National Military Medical Center

Intravesical OnabotulinumtoxinA Injection at the Time of Prolapse Surgery for the Treatment of Overactive Bladder Syndrome: a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889-560
        • Recruiting
        • Walter Reed National Military Medical Center
        • Contact:
          • Walter Reed National Military M Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravesical OnabotulinumtoxinA
The treatment group will receive 100 units of BOTOX® reconstituted in 10mL of injectable preservative-free normal saline at the time of cystoscopy. An injection cystoscopy needle will be set to 3mm and used to inject 0.5mL reconstituted OnabotulinumtoxinA at each injection site, approximately 1cm apart along the posterior bladder wall, for a total of 20 injection sites (4 rows of 5 injection sites). This will be the only treatment.
Drug: OnabotulinumtoxinA 100 UNT
Intravesical injection
Placebo Comparator: Placebo
Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment.
Other: Injectable saline
Intravesical injection
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
From baseline (time of enrollment) to 6-12 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12).
Time Frame: 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.
From baseline (time of enrollment) to 6-12 weeks postoperatively
Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S).
Time Frame: 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.
From baseline (time of enrollment) to 6-12 weeks postoperatively
Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively.
Time Frame: 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.
At 6-12 weeks postoperatively
Urinary tract infection
Time Frame: From time of treatment to 12 weeks postoperative
Rate of urinary tract infections based on clinical suspicion and urine culture results
From time of treatment to 12 weeks postoperative
Urinary retention
Time Frame: 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.
From 2 weeks postoperatively to 12 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed National Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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