Status:
RECRUITING
Reduction in Number of Botox Injections for Urgency Urinary Incontinence
Lead Sponsor:
University of Virginia
Conditions:
Urgency Urinary Incontinence
Eligibility:
FEMALE
21+ years
Phase:
NA
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 Incontine...
Detailed Description
English speaking women ≥21 years old with idiopathic refractory urgency urinary incontinence who have failed first and second line treatment (life style modifications and antispasmodic medications) wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04731961
Start Date
February 23 2021
End Date
December 31 2026
Last Update
January 28 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903