Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Registration Number
- NCT04984317
- Lead Sponsor
- Northwell Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria:<br><br> - Must be female sex and at least 18 years of age.<br><br> - Must be willing and able to complete all procedures and follow-up visits indicated<br> in the protocol.<br><br> - Must have confirmed stress urinary incontinence (SUI) through urodynamic studies.<br><br> - Must have failed two non-invasive incontinence therapies (such as behavior<br> modification, Kegel exercises, etc) for > 3 months.<br><br>Exclusion Criteria:<br><br> - Currently suffering from active urogenital infection.<br><br> - Has incontinence due to neurogenic causes (such as multiple sclerosis,<br> cerebrovascular accident, spinal cord/brain injury, Parkinson Disease,<br> detrusor-external sphincter dyssynergia, or similar conditions).<br><br> - Having concomitant pelvic floor or cystoscopic procedure.<br><br> - Has had prior surgical SUI treatment.<br><br> - Has had prior radiation therapy or brachy therapy.<br><br> - Has an atonic bladder or post-void residual (PVR) above 100cc on two or more<br> occasions.<br><br> - Is pregnant or planning to become pregnant during the study duration.<br><br> - Has a contraindication to therapeutic BOTOX injections or cystoscopic procedures.<br><br> - Is enrolled in a concurrent clinical trial of any treatment (drug or device) that<br> could affect urinary continence or bladder function without the sponsor's approval.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the amount of urinary leakage post-treatment compared to baseline.
- Secondary Outcome Measures
Name Time Method Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.;Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.;Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.;Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.;Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.;Change in quality of life impacted by urinary incontinence via UDI-6.;Change in quality of life impacted by urinary incontinence via IIQ-7.;Assessment of patient satisfaction post-treatment via SSQ-8.;Change in pain post-treatment compared to baseline via VAS.