Clinical trial NCT04984317: Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence
Official title: Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence
Incontinence
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2021-07-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in the amount of urinary leakage post-treatment compared to baseline.
timeFrame: Baseline, 1-month, 3-month, 6-month
Secondary outcomes:
measure: Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
timeFrame: Time of Procedure
measure: Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
timeFrame: 1-month
measure: Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
timeFrame: 3-month
measure: Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.
timeFrame: 6-month
measure: Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.
timeFrame: 1-month, 3-month, 6-month
measure: Change in quality of life impacted by urinary incontinence via UDI-6.
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Change in quality of life impacted by urinary incontinence via IIQ-7.
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Assessment of patient satisfaction post-treatment via SSQ-8.
timeFrame: 1-month
measure: Change in pain post-treatment compared to baseline via VAS.
timeFrame: Baseline, Time of Procedure, 1-month
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Bilal Chughtai, MD
role: PRINCIPAL_INVESTIGATOR
References: