TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Rochester
About this trial
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
Qualifiers
• Women, Age ≥18 years
Diagnosis of SUI
Scheduled to undergo transurethral bulking in the office
Able to read/write English
Disqualifiers
• 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
Trial design
Treatments tested in this trial
- TENS
- Control TENS
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov