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Completed

NCT Number: NCT05330117

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Mean pain measured by Visual Analog Scale (VAS)

    Time frame: Baseline (Before 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.

  2. Mean pain measured by Visual Analog Scale (VAS)

    Time frame: Approximately 2-5 minutes into the 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.

  3. Mean pain measured by Visual Analog Scale (VAS)

    Time frame: 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 outcomes

  1. Mean pain measured by Likert scale

    Time frame: before 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

  2. Mean pain measured by Likert scale

    Time frame: Approximately 2-5 minutes into the 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

  3. Mean pain measured by Likert scale

    Time frame: 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

  4. Number of participants with side effects

    Time frame: 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.

  5. Mean satisfaction with the procedure

    Time frame: within 10 minutes after procedure

    A 1-10 point satisfaction scale will be used where 10 indicates higher satisfaction.

  6. Number of participants who guessed correctly whether they were given the active TENS or placebo TENS

    Time frame: within 10 minutes after procedure

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: TENSOB

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2022
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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