Using TENS for pain relief during outpatient urethral bulking in women with stress urinary incontinence.
Official title: Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Run by University of Rochester · NCT06369922 · Data updated 2026-11-12
This study is testing if using a TENS machine can help reduce pain for women undergoing a specific procedure for stress urinary incontinence.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | January 31, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT06369922 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older diagnosed with stress urinary incontinence who are scheduled for a transurethral bulking procedure.
✕Probably not a fit
Patients with skin damage at the treatment site, those with implanted cardiac devices, or those who have used opioids shortly before the procedure may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a double-blind randomized control study focusing on women with stress urinary incontinence who are scheduled for an outpatient transurethral bulking procedure. Participants will be randomly assigned to receive either transcutaneous electrical nerve stimulation (TENS) for pain relief or a placebo TENS during the procedure. The study aims to evaluate the effectiveness of TENS in reducing pain as measured by a visual analog scale (VAS) and will also assess patient satisfaction and side effects. The outcomes will be measured before, during, and after the procedure to determine the impact of TENS on pain management.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain during outpatient procedures for women suffering from stress urinary incontinence.
How similar studies have gone: While the use of TENS for pain management is established, this specific application during urethral bulking procedures is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Pelvic Health and Continence Specialties
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Jared M Floch, DO, MS
- Email: jared_floch@urmc.rochester.edu
- Phone: 585-895-9301
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.