Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Northwell Health

Status and phase

Suspended

Early Phase 1

Conditions

Stress Urinary Incontinence

Treatments

Drug: onabotulinumtoxin A

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04984317

20-04021756

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.