BOTOX® at the Time of Prolapse Surgery for OAB

Sponsor
Walter Reed National Military Medical Center (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT04807920
Collaborator
(none)
138
1
2
20.2
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: OnabotulinumtoxinA 100 UNT
  • Other: Injectable saline
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Intravesical OnabotulinumtoxinA Injection at the Time of Prolapse Surgery for the Treatment of Overactive Bladder Syndrome: a Randomized Controlled Trial
Actual Study Start Date :
Sep 23, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [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.

    Secondary Outcome Measures

    1. Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12). [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.

    2. Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S). [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.

    3. Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively. [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.

    4. Urinary tract infection [From time of treatment to 12 weeks postoperative]

      Rate of urinary tract infections based on clinical suspicion and urine culture results

    5. Urinary retention [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-560

    Sponsors and Collaborators

    • Walter Reed National Military Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walter Reed National Military Medical Center
    ClinicalTrials.gov Identifier:
    NCT04807920
    Other Study ID Numbers:
    • 3-2021
    First Posted:
    Mar 19, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Walter Reed National Military Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2021