TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Launched by UNIVERSITY OF ROCHESTER · Apr 12, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a method called transcutaneous electrical nerve stimulation (TENS) to help manage pain during a specific treatment for women with stress urinary incontinence (SUI). The treatment being studied is called transurethral bulking, which is done in a doctor's office to help improve bladder control. In this trial, participants will be randomly assigned to one of two groups: one group will receive TENS therapy to help with pain, while the other group will receive a placebo, which means they will not get the actual TENS treatment. This trial aims to find out if TENS can effectively reduce pain during the procedure.
To be eligible for the study, women must be at least 18 years old, have a diagnosis of stress urinary incontinence, and be scheduled for the transurethral bulking procedure. Participants should be able to read and write in English. However, women with certain conditions, such as skin damage in the treatment area or those with implanted heart devices, cannot participate. If you join the trial, you can expect to receive care from experienced doctors and be part of an important study that could help improve pain management for future patients undergoing this procedure.
Gender
FEMALE
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
About University Of Rochester
The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported