TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Last updated: November 4, 2024
Sponsor: University of Rochester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Pain

Treatment

TENS

Control TENS

Clinical Study ID

NCT06369922
STUDY00009315
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • • Women, Age ≥18 years

  • Diagnosis of SUI

  • Scheduled to undergo transurethral bulking in the office

  • Able to read/write English

Exclusion

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 lastdose

  • Participants with altered sensation below the umbilicus

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: TENS
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
June 01, 2026

Study Description

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing outpatient transurethral bulking procedures. These subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study, who oversee the patient's stress urinary incontinence management. The subjects will be asked to participate in this research project when the doctor is offering options for their SUI treatment.

Subjects will be randomized into two groups. One group will undergo transurethral bulking with TENS for analgesia, and the second group will have the procedure performed with placebo TENS. The application of the TENS device will be performed by a study team member who will know to what group the patient was randomized. Both groups will be given the VAS, satisfaction scale, and 5-point Likert scale questionnaires to be answered before, during, and after they undergo treatment on the scheduled day of the procedure.

The primary outcome will be a change in the VAS pain measurement. Investigators hypothesized that TENS used during transurethral bulking injections would result in a 10-mm decrease in VAS compared to placebo TENS.

Secondary outcomes will be:

  1. A discrete 5-point Likert Scale to assess the internal consistency of the pain rating within the study

  2. A satisfaction 10-point scale questionnaire

  3. Rate of side effects to the use of TENS (skin irritation, pain or burning at electrode site) and transurethral bulking injections (vasovagal symptoms: dizziness, nausea, vomiting, shoulder pain, vertigo, sweating, fainting),

  4. Length of procedure.

Connect with a study center

  • Pelvic Health and Continence Specialties

    Rochester, New York 14623
    United States

    Active - Recruiting

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