Reduction in Number of Botox Injections for Urgency Urinary Incontinence

Description

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 Overview

Study Details

Study overview

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.

Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence

Reduction in Number of Botox Injections for Urgency Urinary Incontinence

Condition
Urgency Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22903

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Virginia,

Monique J Vaughan, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

2025-12-31