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Active Not Recruiting NCT04731961

Reduction in Number of Botox Injections for Urgency Urinary Incontinence

Conditions: Urgency Urinary Incontinence

Sex: Female
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: University of Virginia

Location: University of Virginia Charlottesville Virginia

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04731961). StuddyBuddy aggregates publicly available trial information.