Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence
- Registration Number
- NCT04984317
- Lead Sponsor
- Northwell Health
- Brief Summary
The purpose of this study is to assess the effect of onabotulinumtoxin A (BOTOX) injection into the detrusor muscle on increasing bladder compliance to reduce urinary leakage in women suffering from stress urinary incontinence (SUI).
- Detailed Description
The study involves a single-time injection of 100 units of onabotulinumtoxin A into the detrusor muscle of the bladder. Cystoscopy, which is the insertion of a scope with a small camera inside a tube into the participant's urethra. Then the doctor fills the participant's bladder with water or saline and sees detailed images of the injection site in the bladder while administrating the injection.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 20
- Must be female sex and at least 18 years of age.
- Must be willing and able to complete all procedures and follow-up visits indicated in the protocol.
- Must have confirmed stress urinary incontinence (SUI) through urodynamic studies.
- Must have failed two non-invasive incontinence therapies (such as behavior modification, Kegel exercises, etc) for > 3 months.
- Currently suffering from active urogenital infection.
- Has incontinence due to neurogenic causes (such as multiple sclerosis, cerebrovascular accident, spinal cord/brain injury, Parkinson Disease, detrusor-external sphincter dyssynergia, or similar conditions).
- Having concomitant pelvic floor or cystoscopic procedure.
- Has had prior surgical SUI treatment.
- Has had prior radiation therapy or brachy therapy.
- Has an atonic bladder or post-void residual (PVR) above 100cc on two or more occasions.
- Is pregnant or planning to become pregnant during the study duration.
- Has a contraindication to therapeutic BOTOX injections or cystoscopic procedures.
- Is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect urinary continence or bladder function without the sponsor's approval.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Botox Injection onabotulinumtoxin A One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy.
- Primary Outcome Measures
Name Time Method Change in the amount of urinary leakage post-treatment compared to baseline. Baseline, 1-month, 3-month, 6-month 1-hour pad weight, in grams
- Secondary Outcome Measures
Name Time Method Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events. 6-month Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems
Change in patient-reported symptoms of stress incontinence symptoms via PGI-I. 1-month, 3-month, 6-month The Patient Global Impression of Improvement (PGI-I) scale is a scale that measures improvement in symptoms and ranges from 1-7, with 1 indicating very much improvement and higher scores indicating less improvement.
Assessment of patient satisfaction post-treatment via SSQ-8. 1-month The Surgical Satisfaction Questionnaire (SSQ-8) is a questionnaire about patient satisfaction after a surgery/procedure. Responses range from "Very unsatisfied" to "Very Satisfied".
Change in pain post-treatment compared to baseline via VAS. Baseline, Time of Procedure, 1-month Scores are measured on a 100mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain.
Change in quality of life impacted by urinary incontinence via UDI-6. Baseline, 1-month, 3-month, 6-month The Urinary Distress Inventory (UDI-6) is an inventory that assess symptoms and urinary incontinence and its severity on a scale of 0 to 3, with higher scores indicating greater symptom severity. IIQ-7 is a 30-item self-report questionnaire on the impact of urinary incontinence on activities roles and emotional states. Assigned values of the questionnaire are 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly.
Change in quality of life impacted by urinary incontinence via IIQ-7. Baseline, 1-month, 3-month, 6-month The Incontinence Impact Questionnaire (IIQ-7) is a 30-item self-report questionnaire on the impact of urinary incontinence on activities roles and emotional states. Assigned values of the questionnaire are 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly.
Trial Locations
- Locations (1)
Weill Cornell Medicine
🇺🇸New York, New York, United States