Kidney StoneNCT05153629
Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy
A study testing TENS in people with Kidney Stone and Ureteral Calculi, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Stone, Ureteral Calculi, Nephrolithiasis
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2021to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing standard of care ureteroscopy and laser lithotripsy for urinary stone disease
- Patients receiving a stent following their ureteroscopy and laser lithotripsy
Who cannot join
- 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
Show all 9Show fewer
- Patient with implantable stimulators
- Patient with epilepsy
- Patients undergoing laser lithotripsy without stent placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kidney Stone, Ureteral Calculi, Nephrolithiasis
- Being tested
- TENS
- Medical subject headings
- Kidney Calculi, Ureteral Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS device used four times a day for 60 minutes each time
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Assessed daily until removal of stent, approximately 3-10 days after placement
Secondary outcomes (4)
Total Opioid Consumption
Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire.
Measured: Until stent removal (up to 10 days)
Difference in Total Opioid Consumption
Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire.
Measured: 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.
Measured: 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.
Measured: End of study (day 3 to 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start10 Jan 2021
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Conti, Stanford University
- Investigators
- Simon Conti, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153629
- Sponsor's protocol ID
- IRB-62416
- Status last verified
- Sep 2024
- First submitted
- 28 Nov 2021
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Electrical Stimulator as an Adjunct for Pain Control After Ureteroscopic Stone Management
- ClinicalTrials.gov ID
- NCT05153629
- Acronym / sponsor ID
- IRB-62416
- Conditions
- Kidney Stone, Ureteral Calculi, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Posted 22 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Participants will follow standard care until the ureteral stent is removed |
| TENS device | Experimental | Device: TENSParticipants will use the TENS device until the ureteral stent is removed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing standard of care ureteroscopy and laser lithotripsy for urinary stone disease
- Patients receiving a stent following their ureteroscopy and laser lithotripsy
Key exclusion criteria (9 listed)
- Children
- Pregnant patients
- Patients unable to answer pain questionnaire
- Patients undergoing PCNL
- Patients being treated for Urologic malignancy with ureteroscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSTENS device used four times a day for 60 minutes each time | Device | TENS device |
Primary outcome
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)
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)
4 secondary outcomes
Total Opioid Consumption
Time frame: Until stent removal (up to 10 days)
Difference in Total Opioid Consumption
Time frame: Until stent removal (up to 10 days)
Ureteral Stent Discomfort Test (USDT) Scale Score
Time frame: Assessed at removal of stent, approximately 3-10 days after placement
Patient Satisfaction Survey
Time frame: End of study (day 3 to 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Conti, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Kidney Stone and Ureteral Calculi, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on 11-point Visual Analog Score Scale (VAS) (time frame: Assessed daily until removal of stent, approximately 3-10 days after placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.