Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• • Women, Age ≥18 years
‣ Diagnosis of SUI
⁃ Scheduled to undergo transurethral bulking in the office
⁃ Able to read/write English
Locations
United States
New York
Pelvic Health and Continence Specialties
RECRUITING
Rochester
Contact Information
Primary
Jared M Floch, DO, MS
jared_floch@urmc.rochester.edu
585-895-9301
Backup
Diego Hernandez-Aranda, MD
diego_hernandezaranda@urmc.rochester.edu
585-487-3400
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 100
Treatments
Experimental: Active TENS
In the active treatment group, the TENS unit will remain on up to 30 minutes (10 minutes pre-procedure, during the procedure and during the questionnaires).
Sham_comparator: Control TENS
The sham stimulation group will undergo the same procedure; however, the TENS stimulation current will be reduced to a minimal detectable level and turned off after 20 seconds.
Related Therapeutic Areas
Sponsors
Leads: University of Rochester