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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05153629
Other study ID # IRB-62416
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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