TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Recruiting now · Not applicable
Conditions studied: Stress Incontinence Female, Urinary Incontinence, Urinary Incontinence,Stress, Pain, Pain Acute
In brief
This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.
Key facts
- Study ID
- NCT06369922
- Run by
- University of Rochester
- People needed
- 100
- Starts
- 2024-07-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- • Women, Age ≥18 years
- Diagnosis of SUI
- Scheduled to undergo transurethral bulking in the office
- Able to read/write English
You may not qualify if…
- • 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 is running
- Pelvic Health and Continence Specialties — Rochester, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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