Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05153629

Collaborator

(none)

Enrollment

Location

Arms

16.7

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone Ureteral Calculi Nephrolithiasis	Device: TENS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard care Participants will follow standard care until the ureteral stent is removed
Experimental: TENS device Participants will use the TENS device until the ureteral stent is removed	Device: TENS TENS device used four times a day for 60 minutes each time

Arm

Intervention/Treatment

No Intervention: Standard care

Participants will follow standard care until the ureteral stent is removed

Experimental: TENS device

Participants will use the TENS device until the ureteral stent is removed

Device: TENS

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Simon Conti, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Simon Conti, Clinical Assistant Professor, Urology, Stanford University

ClinicalTrials.gov Identifier:

NCT05153629

Other Study ID Numbers:

IRB-62416

First Posted:

Dec 10, 2021

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022