Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

NCT05153629 | Completed Results FDA Device

• 1 other identifier: IRB-62416
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone; Ureteral Calculi; Nephrolithiasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Total Opioid Consumption

  Until stent removal (up to 10 days)

• Difference in Total Opioid Consumption

  Until stent removal (up to 10 days)

• Ureteral Stent Discomfort Test (USDT) Scale Score

  Assessed at removal of stent, approximately 3-10 days after placement

• Patient Satisfaction Survey

  End of study (day 3 to 10)

Study Arms (2)

Standard care

NO INTERVENTION

Participants will follow standard care until the ureteral stent is removed

TENS device

EXPERIMENTAL

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

Device: TENS

Interventions

TENS DEVICE

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

TENS device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Ureteral Calculi; Nephrolithiasis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Simon Conti, MD
• Organization: Stanford University

sconti@stanford.edu

650-723-3391

Study Officials

• Simon Conti, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Urology

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 10, 2021
• Study Start: January 10, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 22, 2024
• Results First Posted: October 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)