Reduction in Number of Botox Injections for Urgency Urinary Incontinence

Launched by UNIVERSITY OF VIRGINIA · Jan 26, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether a new method of giving Botox injections can effectively reduce symptoms of urgency urinary incontinence (UUI), which is when you have a sudden, strong urge to urinate. The study aims to see if giving Botox at just five sites instead of the usual 15 to 20 sites can provide similar relief from UUI symptoms. Researchers believe that using fewer injection sites will still help reduce the number of times participants experience urgent urination throughout the day.

To participate, women must be at least 21 years old, speak English, and experience frequent episodes of urgency urinary incontinence, confirmed by a diary they keep for three days. They should also be willing to perform certain medical procedures if needed. Participants can expect to receive Botox injections and will need to attend scheduled study visits to monitor their progress. It's important to note that individuals currently experiencing a urinary tract infection, or those with specific medical conditions, may not be eligible for the study. If you're interested in learning more or think you may qualify, please reach out to the study team!

Gender

FEMALE

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