Actively Recruiting
Reduction in Number of Botox Injections for Urgency Urinary Incontinence
Led by University of Virginia · Updated on 2025-01-28
56
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Reduction in Number of Botox Injections for Urgency Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 21 years or older
- English speaking
- Five or more urge urinary incontinence episodes recorded on a three-day voiding diary
- Urge predominant urinary incontinence (urge more than 50% of total episodes) based on self-report
- Willingness to perform clean intermittent catheterization or have an indwelling catheter if required
- Requesting treatment for urgency urinary incontinence
- Previous trial and failure of lifestyle modifications and at least one antispasmodic medication
- Completed a 3-week washout period if previously on anticholinergic therapy
- Able to complete all study-related tasks and interviews
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- Current symptomatic urinary tract infection not resolved before enrollment
- Need for intermittent self-catheterization at baseline
- Post-void residual volume greater than 150 mL on two occasions with voids over 150 mL
- Planned or recommended surgical treatment for stress incontinence or pelvic organ prolapse
- Prior intra-detrusor botulinum toxin A injections
- Previous or current neuromodulation implants
- Surgically altered bladder muscle such as augmentation cystoplasty
- Known allergy to botulinum toxin A or lidocaine
- Known neurologic diseases affecting urinary function (e.g., stroke, Parkinson's, multiple sclerosis)
- Pregnant, lactating, or planning pregnancy within one year
- Sexually active premenopausal women with a uterus not using approved contraception or without tubal ligation
- Cystoscopic findings preventing injection
- Current or prior bladder cancer
- Inability to complete a 3-day voiding diary
- Diagnosis of interstitial cystitis or chronic pelvic pain syndrome
- Uninvestigated hematuria
- Serum creatinine over twice the upper normal limit within the past year
- Two or more hospitalizations for medical conditions in the past year
- Plans to move away within the next 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
M
Monique Vaughan, MD
CONTACT
A
amanda r urban, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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