Actively Recruiting
Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence
Led by University of Rochester · Updated on 2026-05-13
100
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Diagnosis of stress urinary incontinence (SUI)
- Scheduled to undergo transurethral bulking procedure in the office
- Able to read and write English
You will not qualify if you...
- Cutaneous damage such as ulcers or broken skin on the target treatment area
- Implanted cardiac pacemaker or defibrillator
- Use of opioids for pain management within 8 hours before the procedure
- Altered sensation below the umbilicus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Same day procedure
Participants undergo a transurethral bulking procedure with either active TENS for analgesia or placebo TENS. The TENS device is applied 5 to 10 minutes before and remains active during the procedure, which typically takes 5 to 15 minutes. Participants complete pain and satisfaction questionnaires before, during, and after the procedure.
1 outpatient procedure visit
Trial Site Locations
Total: 1 location
1
Pelvic Health and Continence Specialties
Rochester, New York, United States, 14623
Actively Recruiting
Research Team
J
Jared M Floch, DO, MS
D
Diego Hernandez-Aranda, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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