TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence. — TENSUB  

Pain Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06369922
• Study type: Interventional
• Source: University of Rochester
• Contact: Jared M Floch, DO, MS
• Phone: 585-895-9301
• Email: jared_floch@urmc.rochester.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Completion date: June 1, 2026