Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

Kidney Stone Clinical Trial

Official title:

Noninvasive Electrical Stimulator as an Adjunct for Pain Control After Ureteroscopic Stone Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153629
• Other study ID #: IRB-62416
• Status: Completed
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will assess the use of Transcutaneous Neurostimulation (TENS), a pharmacological alternative, for treatment of ureteral stent pain post-ureteroscopy. The primary aim for the investigators is to determine if use of a TENS unit will reduce post-operative pain and nausea associated with the ureteral stent. Secondary aim will be to assess if it can help minimize narcotic use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult patients undergoing standard of care ureteroscopy and laser lithotripsy for urinary stone disease
• Patients receiving a stent following their ureteroscopy and laser lithotripsy

Exclusion Criteria:

• Children
• Pregnant patients
• Patients unable to answer pain questionnaire
• Patients undergoing PCNL
• Patients being treated for Urologic malignancy with ureteroscopy
• Patients who require long term or chronic ureteral stent management
• Patient with implantable stimulators
• Patient with epilepsy
• Patients undergoing laser lithotripsy without stent placement

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis

Intervention

Device:
• TENS
TENS device used four times a day for 60 minutes each time

Locations

Country	Name	City	State
United States	Stanford	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on 11-point Visual Analog Score scale for each day until Ureteral Stent removed	VAS is a validated tool widely used to assess pain intensity. Possible scores range from 0 (no pain) to 10 (worst possible pain)	3-10 days