TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Pain Clinical Trial

— TENSUB  

Official title:

Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369922
• Other study ID #: STUDY00009315
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Jared M Floch, DO, MS
• Phone: 585-895-9301
• Email: jared_floch[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress 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 the cystoscopy with placebo TENS.

Description:

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing outpatient transurethral bulking procedures. These subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study, who oversee the patient's stress urinary incontinence management. The subjects will be asked to participate in this research project when the doctor is offering options for their SUI treatment.

Subjects will be randomized into two groups. One group will undergo transurethral bulking with TENS for analgesia, and the second group will have the procedure performed with placebo TENS. The application of the TENS device will be performed by a study team member who will know to what group the patient was randomized. Both groups will be given the VAS, satisfaction scale, and 5-point Likert scale questionnaires to be answered before, during, and after they undergo treatment on the scheduled day of the procedure.

The primary outcome will be a change in the VAS pain measurement. Investigators hypothesized that TENS used during transurethral bulking injections would result in a 10-mm decrease in VAS compared to placebo TENS.

Secondary outcomes will be:

1. A discrete 5-point Likert Scale to assess the internal consistency of the pain rating within the study

2. A satisfaction 10-point scale questionnaire

3. Rate of side effects to the use of TENS (skin irritation, pain or burning at electrode site) and transurethral bulking injections (vasovagal symptoms: dizziness, nausea, vomiting, shoulder pain, vertigo, sweating, fainting),

4. Length of procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Women, Age =18 years

• Diagnosis of SUI

• Scheduled to undergo transurethral bulking in the office

• Able to read/write English

Exclusion Criteria:

• • 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

• Enuresis
• Pain
• Pain Acute
• Stress Incontinence Female
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

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 (the procedure typically takes 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 (the procedure typically takes 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	Pelvic Health and Continence Specialties	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.	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	TENS or NO TENS	Number of participants who guessed correctly whether they were given the active TENS or placebo TENS	within 10 minutes after procedure