Reduction in Number of Botox Injections for Urgency Urinary Incontinence

NCT04731961 | Recruiting

• 1 other identifier: HSR200175
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reducton of Urgency Urinary Incontinence episodes in standard of care versus modified treatment group

  To determine if a reduced injection site protocol (5 injection sites) of intra-detrusor Onabotulinumtoxin-A is non-inferior in the treatment of refractory urgency urinary incontinence as compared to the standard injection site protocol (15 injection sites). This endpoint will be measured by reduction in the number of UUI episodes per day.

  6 months

Secondary Outcomes (2)

• Quality of life improvement in standard of care (15 injections) versus modified treatment (5 injections)

  6 months

• Complications rates in standard of care (15 injections) versus modified treatment (5 injections)

  6 months

Study Arms (2)

Controls

ACTIVE COMPARATOR

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

Procedure: Standard of care (15 Botox injections)

Experimental

EXPERIMENTAL

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

Procedure: Experimental Arm (5 Botox injections)

Interventions

Standard of care (15 Botox injections) PROCEDURE

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

Controls

Experimental Arm (5 Botox injections) PROCEDURE

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.

Experimental

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Monique J Vaughan, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monique Vaughan, MD

CONTACT

4349241955; MV4W@hscmail.mcc.virginia.edu

amanda r urban, MS

CONTACT

14344093100; amandareeferurban@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will not be informed of which arm they are assigned to before the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be assigned to arms with either 5 or 15 injections.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: February 23, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)