Using TENS for Pain Relief During Outpatient Urethral Bulking Treatment in Women with Stress Urinary Incontinence

What this Trial Is About

Researchers are evaluating the use of transcutaneous electrical nerve stimulation TENS for pain relief during outpatient transurethral bulking procedures in women with stress urinary incontinence SUI. This double-blind randomized controlled trial compares TENS analgesia to a placebo TENS during the procedure to understand if TENS can reduce pain experienced by patients. The study is led by urologists and urogynecologists at the University of Rochester who manage stress urinary incontinence care. Participants will be randomized into two groups. One group will receive active TENS applied 5 minutes before and during the transurethral bulking procedure, with electrodes placed on bilateral paraspinal muscles to deliver nerve stimulation. The other group will have a sham TENS with minimal current applied briefly before being turned off during the procedure. The procedure typically lasts 5 to 15 minutes, and the TENS device settings are adjusted for comfortable sensation without pain. Both groups will complete pain and satisfaction questionnaires before, during, and after the procedure. Participants will be asked to complete pain assessments using the Visual Analog Scale VAS, a 5-point Likert scale for pain consistency, and a 10-point satisfaction scale on the day of their procedure. Researchers will monitor for side effects such as skin irritation or vasovagal symptoms and record procedure length. The main outcome measured is the change in pain levels during and after the procedure. The study will continue until June 2027, with careful monitoring throughout the treatment day.

TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.