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Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Phase 1
Suspended
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

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.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in the amount of urinary leakage post-treatment compared to baseline.
Secondary Outcome Measures
NameTimeMethod
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.
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