NCT04984317SuspendedEarly Phase 1
Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Suspended
- Sponsor
- Northwell Health
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in the amount of urinary leakage post-treatment compared to baseline.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Botox Injection
Experimental
One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy.
Intervention: onabotulinumtoxin A (Drug)
Outcomes
Primary Outcomes
Change in the amount of urinary leakage post-treatment compared to baseline.
Time Frame: Baseline, 1-month, 3-month, 6-month
1-hour pad weight, in grams
Secondary Outcomes
- Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.(6-month)
- Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.(1-month, 3-month, 6-month)
- Assessment of patient satisfaction post-treatment via SSQ-8.(1-month)
- Change in pain post-treatment compared to baseline via VAS.(Baseline, Time of Procedure, 1-month)
- Change in quality of life impacted by urinary incontinence via UDI-6.(Baseline, 1-month, 3-month, 6-month)
- Change in quality of life impacted by urinary incontinence via IIQ-7.(Baseline, 1-month, 3-month, 6-month)
- Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.(Time of Procedure)
- Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.(1-month)
- Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.(3-month)
Investigators
Study Sites (1)
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