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

Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Operative Cystoscopy for Overactive Bladder: A Randomized Control Trial (TENSOB Study)

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Urinary Incontinence; Pain, Acute
• Intervention / Treatment: Procedure: TENS; Procedure: Control TENS

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active 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).	Procedure: TENS; This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (procedure typically will take from 5-15 minutes). The TENS units have pre-program settings improving convenience, reproducibility and reliability. Study staff will be instructed to perform TENS using an "Acupuncture" mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.
Sham Comparator: 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.	Procedure: Control TENS; This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (procedure typically will take from 5-15 minutes). The TENS units have pre-program settings improving convenience, reproducibility and reliability. Study staff will be instructed to perform TENS using an "Acupuncture" mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pain measured by Visual Analog Scale (VAS)	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.	Baseline (Before procedure)
Mean pain measured by Visual Analog Scale (VAS)	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.	Approximately 2-5 minutes into the procedure
Mean pain measured by Visual Analog Scale (VAS)	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.	within 10 minutes after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pain measured by Likert scale	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	before procedure
Mean pain measured by Likert scale	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	Approximately 2-5 minutes into the procedure
Mean pain measured by Likert scale	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	within 10 minutes after procedure
Number of participants with side effects	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.	within 10 minutes after procedure
Mean satisfaction with the procedure	A 1-10 point satisfaction scale will be used where 10 indicates higher satisfaction.	within 10 minutes after procedure
Number of participants who guessed correctly whether they were given the active TENS or placebo TENS		within 10 minutes after procedure

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Pain; Neurologic Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Acute Pain
• Other Study ID Numbers: STUDY00005257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No