Using TENS for pain relief during outpatient urethral bulking in women with stress urinary incontinence.
Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT06369922 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older diagnosed with stress urinary incontinence who are scheduled for a transurethral bulking procedure.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rochester, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.