NCT06369922 TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
| NCT ID | NCT06369922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Stress Incontinence Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-07-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06369922 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Stress Incontinence Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06369922 currently recruiting?
Yes, NCT06369922 is actively recruiting participants. Contact the research team at jared_floch@urmc.rochester.edu for enrollment information.
Where is the NCT06369922 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06369922 clinical trial?
NCT06369922 is sponsored by University of Rochester. The trial plans to enroll 100 participants.