Nerve Stimulation Using a TENS to Provide Pain Relief During Surgery for Overactive Bladder

Not Applicable

Completed

• Conditions: Urinary Incontinence; Overactive Bladder; Pain, Acute
• Interventions: Procedure: Control TENS; Procedure: TENS

• Registration Number: NCT05330117
• Lead Sponsor: University of Rochester

Brief Summary

This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Subjects will be identified by the University of Rochester Urologists and Urogynecologists participating in the study who currently oversee urinary urge 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 cystoscopy with placebo TENS.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-14
• Primary Completion: 2022-03-03
• Study Completion: 2022-03-03
• Status Verified: 2022-04
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-14
• Last Update Submitted: 2022-04-14
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Men and Women, Age ≥18 years
• Diagnosis of OAB/UUI,
• Scheduled to undergo intravesical Botox injections in the office
• Able to read/write English

Exclusion criteria:

• Currently undergoing Sacral Neuromodulation
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
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).

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
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
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.
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 who guessed correctly whether they were given the active TENS or placebo TENS	within 10 minutes after procedure

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States