Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence

20-04021756

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).

2022-02-14

2024-08-01

2025-08-01

Early phase I

20

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2023-10-16