Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

  • STATUS
    Recruiting
  • End date
    Aug 14, 2023
  • participants needed
    20
  • sponsor
    Weill Medical College of Cornell University
Updated on 14 March 2022
Accepts healthy volunteers

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).

Details
Condition Stress Urinary Incontinence
Treatment Onabotulinumtoxin A
Clinical Study IdentifierNCT04984317
SponsorWeill Medical College of Cornell University
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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