Back to resultsNoninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy
Primary Purpose
Kidney Stone, Ureteral Calculi, Nephrolithiasis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone
Eligibility Criteria
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
Sites / Locations
- StanfordRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
TENS device
Arm Description
Participants will follow standard care until the ureteral stent is removed
Participants will use the TENS device until the ureteral stent is removed
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05153629
Brief Title
Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy
Official Title
Noninvasive Electrical Stimulator as an Adjunct for Pain Control After Ureteroscopic Stone Management
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Ureteral Calculi, Nephrolithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Participants will follow standard care until the ureteral stent is removed
Arm Title
TENS device
Arm Type
Experimental
Arm Description
Participants will use the TENS device until the ureteral stent is removed
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
TENS device used four times a day for 60 minutes each time
Primary Outcome Measure Information:
Title
Pain on 11-point Visual Analog Score scale for each day until Ureteral Stent removed
Description
VAS is a validated tool widely used to assess pain intensity. Possible scores range from 0 (no pain) to 10 (worst possible pain)
Time Frame
3-10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Conti
Phone
(650) 723-3391
Email
sconti@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Conti, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Conti, MD
Phone
650-723-3391
Email
sconti@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy
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