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Recruiting NCT06369922

TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Trial Parameters

Condition Stress Incontinence Female
Sponsor University of Rochester
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-07-01
Completion 2026-01-31
Interventions
TENSControl TENS

Brief 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 Criteria

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

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