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

Urinary Incontinence Clinical Trial

— TENSOB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05330117
• Other study ID #: STUDY00005257
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: March 3, 2022

Study information

• Verified date: April 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Overactive Bladder
• Pain, Acute
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean satisfaction with the procedure	A 1-10 point satisfaction scale will be used where 10 indicates higher satisfaction.	within 10 minutes after procedure
Secondary	Number of participants who guessed correctly whether they were given the active TENS or placebo TENS		within 10 minutes after procedure