Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

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.