Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence
Paused · Early Phase 1
Conditions studied: Stress Urinary Incontinence
In brief
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).
Key facts
- Study ID
- NCT04984317
- Run by
- Northwell Health
- People needed
- 20
- Starts
- 2022-02-14
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Weill Cornell Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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