Recruiting

Botox

Sponsor:

University of Virginia

Code:

NCT04731961

Conditions

Urgency Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Standard of care (15 Botox injections)

Experimental Arm (5 Botox injections)

Study Details

Brief summary:

The overall objective of this study is to determine if a reduced injection site protocol (5 injection sites) using an equivalent amount of Botox provides comparable relief of Urgency Urinary Incontinence (UUI) symptoms compared to the standard injection site protocol (15-20 injection sites). Our central hypothesis is that the 5-site injection protocol is non-inferior in terms of relief of UUI symptoms compared to the standard injection site protocol, measured by a non-inferior reduction in the number of UUI episodes per day.

Conditions

Urgency Urinary Incontinence

Study ID

NCT04731961

Start date

Feb 23, 2021

Status verified date

Jan, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Females at least 21 years of age
  • English speaking
  • Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing for self-characterization of incontinence type
  • Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary
  • Patient or caregiver willing to perform clean intermittent catheterization, or patient willing to have indwelling Foley catheter in the event this would be required
  • Request for treatment for urgency urinary incontinence. The patient may have tried other pharmacologic treatments for urge incontinence, such as antispasmodic agents or non-pharmacologic treatments, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
  • Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment
  • Subject is able to complete all study related items and interviews
  • Willingness and ability to comply with scheduled visits and study procedures.

Exclusion Criteria:

  • Current symptomatic urinary tract infection that has not resolved prior to randomization.
  • Baseline need for intermittent self-catheterization
  • PVR (Post void residual) >150 mL on 2 occasions with void(s) of greater than 150 mL
  • Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
  • Any prior intra-detrusor botulinum toxin A injections
  • Previous or currently implanted neuromodulation (sacral or tibial).
  • Surgically altered detrusor muscle, such as augmentation cystoplasty.
  • Known allergy to botulinum toxin A.
  • Women with known neurologic disease believed to potentially affect urinary function (history of stroke, Parkinson's disease, multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
  • Known allergy to lidocaine.
  • Currently pregnant or lactating patients or patients planning pregnancy within the next year.
  • Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study.
  • Cystoscopic findings that preclude injection, in the opinion of the investigator.
  • Current or prior bladder malignancy.
  • Inability to understand diary instructions and complete 3-day voiding diary.
  • Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
  • Subjects with hematuria who have not undergone a clinically appropriate evaluation.
  • Serum creatinine level greater than twice the upper limit of normal within the previous year.
  • Two or more hospitalizations for medical conditions in the previous years
  • Plans to move out of area in the next 6 months

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Controls

Subjects in this arm will be administered the standard injection site protocol (15 sites).

experimental: Experimental

Subjects in this arm will be administered the same amount of Botox in 5 injection sites.

Interventions

Standard of care (15 Botox injections)

The controls will be given the standard of care of 15 Botox injections.

Experimental Arm (5 Botox injections)

5 Botox injections will be given, with each injection containing three times the amount of Botox than each of the 15 injections given in the standard of care arm.

Primary outcome measure

  • Reducton of Urgency Urinary Incontinence episodes in standard of care versus modified treatment group [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Monique Vaughan, MD

4349241955MV4W@hscmail.mcc.virginia.edu

amanda r urban, MS

14344093100amandareeferurban@gmail.com

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Monique Vaughan, MD

4349242103mv4w@UVAHEALTH.ORG

More Information

Sponsor

University of Virginia

Last update posted

Jan 28, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-01-28.