RECRUITING

TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Quick Facts

Study Start:2024-07-01
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06369922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Women, Age ≥18 years
  2. * Diagnosis of SUI
  3. * Scheduled to undergo transurethral bulking in the office
  4. * Able to read/write English
  1. * • Cutaneous damage such as ulcers or broken skin on target treatment area
  2. * Currently implanted cardiac pacemaker or defibrillator
  3. * Pre-procedural use of opioids for pain management, less than 8 hours from last dose
  4. * Participants with altered sensation below the umbilicus

Contacts and Locations

Study Contact

Jared M Floch, DO, MS
CONTACT
585-895-9301
jared_floch@urmc.rochester.edu
Diego Hernandez-Aranda, MD
CONTACT
585-487-3400
diego_hernandezaranda@urmc.rochester.edu

Study Locations (Sites)

Pelvic Health and Continence Specialties
Rochester, New York, 14623
United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • TENS
  • pain
  • Transcutaneous Electrical Nerve Stimulation Analgesia

Additional Relevant MeSH Terms

  • Stress Incontinence Female
  • Urinary Incontinence
  • Urinary Incontinence,Stress
  • Pain
  • Pain Acute