Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis; Ureteral Calculi; Kidney Stone
• Intervention / Treatment: Device: TENS

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on 11-point Visual Analog Score Scale (VAS)	Cumulative average pain score using an 11-point VAS. The VAS is a validated tool widely used to assess pain intensity. Possible score ranges: Scale for back pain: 0 (no pain) - 10 (worst pain); Abdominal/Groin Pain: 0 (no pain) - 10 (worst pain); Pain Frequency: 0 (not at all) - 10 (All day or night long); Nausea intensity: 0 (No nausea) - 10 (Worst possible nausea)	Assessed daily until removal of stent, approximately 3-10 days after placement
Difference in Pain on 11-point Visual Analog Score Scale (VAS)	Cumulative average difference in pain score using an 11-point VAS. The VAS is a validated tool widely used to assess pain intensity. Possible score ranges: Scale for back pain: 0 (no pain) - 10 (worst pain); Abdominal/Groin Pain: 0 (no pain) - 10 (worst pain); Pain Frequency: 0 (not at all) - 10 (All day or night long); Nausea intensity: 0 (No nausea) - 10 (Worst possible nausea)	Assessed daily until removal of stent, approximately 3-10 days after placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption	Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire.	Until stent removal (up to 10 days)
Difference in Total Opioid Consumption	Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire.	Until stent removal (up to 10 days)
Ureteral Stent Discomfort Test (USDT) Scale Score	Overall score scale:0 to 61 points; subdomain scales: urinary symptoms: 0 to 30; pain: 0 to 6: daily life: 0 to 5; sexual life: 0 to 5; medical care/analgesic use: 0 to 10; and overall quality of life: 0 to 5. Subscale scores are totaled to calculate the overall score. Higher scores correspond to more severe symptoms for the overall score and all subscale scores.	Assessed at removal of stent, approximately 3-10 days after placement
Patient Satisfaction Survey	Participants were asked if they would prefer using TENS over pain medication during a pain episode, and whether they would consider using TENS over pain medication in the future. This outcome was assessed only in participants who were randomized to the TENS device group.	End of study (day 3 to 10)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Simon Conti, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: November 28, 2021
• First Submitted That Met QC Criteria: November 28, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Ureteral Diseases; Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Calculi
• Other Study ID Numbers: IRB-62416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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