Recruiting

BOTOX®

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT04807920

Conditions

Urinary Bladder, Overactive

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OnabotulinumtoxinA 100 UNT

Injectable saline

Study Details

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.

Conditions

Urinary Bladder, Overactive

Pelvic Organ Prolapse

Study ID

NCT04807920

Start date

Sep 23, 2021

Status verified date

Mar, 2021

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

OnabotulinumtoxinA 100 UNT

Intravesical injection

Injectable saline

Intravesical injection

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Joy E Wheat, MD

201-710-5109joy.e.wheat.mil@mail.mil

Christine Vaccaro, DO

301-400-2468christine.m.vaccaro.mil@mail.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-560

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Oct 14, 2021

Last verified

Mar, 2021

Keywords

  • Botulinum Toxins, Type A
  • Mixed Urinary Incontinence
  • Urgency urinary incontinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2021-10-14.