Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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.

More Urinary Incontinence trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment100 (estimated)
SponsorUniversity of Rochester
Academic / other
Locations1 site (Rochester, New York)
StatusRecruiting
StartedJuly 1, 2024
Main results expectedJanuary 31, 2027
Study endsJune 1, 2027
Registry record updatedMay 13, 2026
Trial IDNCT06369922 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.