TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Not Applicable

Recruiting

• Conditions: Pain Acute; Urinary Incontinence,Stress; Stress Incontinence Female; Urinary Incontinence; Pain
• Interventions: Procedure: TENS; Procedure: Control TENS

• Registration Number: NCT06369922
• Lead Sponsor: University of Rochester

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Study Start: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active TENS	TENS	In the active treatment group, the TENS unit will remain on up to 30 minutes (10 minutes pre-procedure, during the procedure and during the questionnaires).
Control TENS	Control TENS	The sham stimulation group will undergo the same procedure; however, the TENS stimulation current will be reduced to a minimal detectable level and turned off after 20 seconds.

Primary Outcome Measures

Name	Time	Method
Mean pain measured by Visual Analog Scale (VAS)	within 10 minutes after procedure	The VAS for pain consists of a 100-mm-long horizontal line where 0-mm equals no pain and 100-mm equals worst possible pain.

Secondary Outcome Measures

Name	Time	Method
TENS or NO TENS	within 10 minutes after procedure	Number of participants who guessed correctly whether they were given the active TENS or placebo TENS
Mean pain measured by Likert scale	within 10 minutes after procedure	A discrete, 5-point verbal Likert scale including the following options: "no pain", "minimal pain", "moderate pain", "severe pain" and "worst pain possible" will be asked to patients
Mean satisfaction with the procedure	within 10 minutes after procedure	A 1-10 point satisfaction scale will be used where 10 indicates higher satisfaction.
Number of participants with side effects	within 10 minutes after procedure	A check list of vasovagal symptoms will be handed to the study team member to complete if the subject reports any light headedness, nausea or sweating.

Trial Locations

Locations (1)

Pelvic Health and Continence Specialties; 🇺🇸 Rochester, New York, United States