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Completed

NCT Number: NCT05153629

Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Device

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

Primary outcomes

  1. Pain on 11-point Visual Analog Score Scale (VAS)

    Time frame: Assessed daily until removal of stent, approximately 3-10 days after placement

    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)

  2. Difference in Pain on 11-point Visual Analog Score Scale (VAS)

    Time frame: Assessed daily until removal of stent, approximately 3-10 days after placement

    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)

Secondary outcomes

  1. Total Opioid Consumption

    Time frame: Until stent removal (up to 10 days)

    Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire.

  2. Difference in Total Opioid Consumption

    Time frame: Until stent removal (up to 10 days)

    Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire.

  3. Ureteral Stent Discomfort Test (USDT) Scale Score

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

    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.

  4. Patient Satisfaction Survey

    Time frame: End of study (day 3 to 10)

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2021
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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