Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

NCT ID: NCT05153629

Last Updated: 2024-10-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2023-10-01

Brief Summary

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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

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Conditions

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Kidney Stone Ureteral Calculi Nephrolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard care

Participants will follow standard care until the ureteral stent is removed

Group Type NO_INTERVENTION

No interventions assigned to this group

TENS device

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

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

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

Interventions

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TENS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Simon Conti

Clinical Assistant Professor, Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Conti, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-62416

Identifier Type: -

Identifier Source: org_study_id

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