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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05330117
Other study ID # STUDY00005257
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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