Urgency Urinary Incontinence Clinical Trial
Official title:
Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence
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.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quality of life improvement in standard of care (15 injections) versus modified treatment (5 injections) | To compare quality of life and treatment satisfaction scores between the reduced injection site group and the standard injection site group using validated questionnaires. This endpoint will be measured by improvements in numerical scores of patient's perceived quality of life and treatment satisfaction after completion of the procedure. | 6 months | |
Secondary | Complications rates in standard of care (15 injections) versus modified treatment (5 injections) | To determine if the reduced site injection protocol has similar complication rates compared to the standard injection site protocol, specifically: urinary tract infection, post procedure urinary retention, hematuria, pain, and transient weakness. This endpoint will be measured by frequency of complications encountered among each treatment arm. | 6 months |
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