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

NCT05330117 | Completed

• 1 other identifier: STUDY00005257
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Overactive Bladder; Pain, Acute

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Mean pain measured by Likert scale

  before procedure

• Mean pain measured by Likert scale

  Approximately 2-5 minutes into the procedure

• Mean pain measured by Likert scale

  within 10 minutes after procedure

• Number of participants with side effects

  within 10 minutes after procedure

• Mean satisfaction with the procedure

  within 10 minutes after procedure

Study Arms (2)

Active TENS

EXPERIMENTAL

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

Control TENS

SHAM COMPARATOR

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

Interventions

TENS PROCEDURE

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.

Active TENS

Control TENS PROCEDURE

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.

Control TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Hernandez-Aranda D, Panza J, Eigg M, Greenstein M, Li D, O'Brien J, Warren G, Doyle PJ. Analgesia Using Transcutaneous Electric Nerve Stimulation in Office Bladder Chemodenervation, a Randomized Controlled Trial. Urogynecology (Phila). 2024 May 1;30(5):498-504. doi: 10.1097/SPV.0000000000001424. Epub 2023 Nov 6.

  PMID: 37930264 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive; Acute Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 15, 2022
• Study Start: December 14, 2020
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)