Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

Not Applicable

Completed

• Conditions: Ureteral Calculi; Kidney Stone; Nephrolithiasis
• Interventions: Device: TENS

• Registration Number: NCT05153629
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-10
• Study First Submitted: 2021-11-28
• Study First Submitted QC: 2021-11-28
• Study First Posted: 2021-12-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-09
• Results First Submitted: 2024-09-30
• Results First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Results First Posted: 2024-10-22
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS device	TENS	Participants will use the TENS device until the ureteral stent is removed

Primary Outcome Measures

Name	Time	Method
Pain on 11-point Visual Analog Score Scale (VAS)	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)
Difference in Pain on 11-point Visual Analog Score Scale (VAS)	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 Outcome Measures

Name	Time	Method
Total Opioid Consumption	Until stent removal (up to 10 days)	Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire.
Difference in Total Opioid Consumption	Until stent removal (up to 10 days)	Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire.
Ureteral Stent Discomfort Test (USDT) Scale Score	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.
Patient Satisfaction Survey	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.

Trial Locations

Locations (1)

Stanford; 🇺🇸 Stanford, California, United States