Reducing Botox injections for treating urgency urinary incontinence
Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence
This study is testing if using fewer Botox injection sites can still help women with tough-to-treat bladder issues feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT04731961 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether a reduced injection site protocol using five Botox injection sites can provide similar relief from urgency urinary incontinence (UUI) symptoms as the standard protocol, which uses 15-20 injection sites. The participants will be English-speaking women aged 21 and older who have idiopathic refractory UUI and have not responded to previous treatments. They will complete a voiding diary and questionnaires before receiving their first Botox injection, and the effectiveness will be measured by the reduction in UUI episodes per day. The study will compare outcomes between the standard and experimental injection protocols.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women aged 21 and older with refractory urgency urinary incontinence who have failed previous treatments.
Not a fit: Patients who have not experienced urgency urinary incontinence or those who have not tried first and second line treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer injections needed for effective treatment of urgency urinary incontinence, improving patient comfort and convenience.
How similar studies have performed: While similar approaches have been explored, this specific reduced injection site protocol is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Monique J Vaughan, MD — University of Virginia
- Study coordinator: Monique Vaughan, MD
- Email: MV4W@hscmail.mcc.virginia.edu
- Phone: 4349241955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.