RecruitingNot Applicable

TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

United States100 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Women, Age ≥18 years * Diagnosis of SUI * Scheduled to undergo transurethral bulking in the office * Able to read/write English Exclusion Criteria: * • Cutaneous damage such as ulcers or broken skin on target treatment area * Currently implanted cardiac pacemaker or defibrillator * Pre-procedural use of opioids for pain management, less than 8 hours from last dose * Participants with altered sensation below the umbilicus

What they're measuring

Mean pain measured by Visual Analog Scale (VAS)

Timeframe: Before procedure

Mean pain measured by Visual Analog Scale (VAS)

Timeframe: Approximately 2-5 minutes into the procedure

Mean pain measured by Visual Analog Scale (VAS)

Timeframe: within 10 minutes after procedure

Trial details

NCT IDNCT06369922

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-31

Contact for this trial

Jared M Floch, DO, MS

585-895-9301 jared_floch@urmc.rochester.edu

View on ClinicalTrials.gov More Stress Incontinence Female trials