An interventional study of TENS in Kidney Stone, Ureteral Calculi and Nephrolithiasis, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
Among 193 studies in Kidney Calculi with a site in United States — 42 open to participants now, 58 under way, none of them phase 3. Kidney Calculi · United States.
Among the 193 studies in Kidney Calculi with a site in United States, this one is the 87th largest by enrollment of the 165 interventional ones that give a count, is one of 15 that started in 2021, is one of 113 with no phase, and was the 127th registered.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
Browse Kidney Calculi studies →42 of the 193 studies in Kidney Calculi with a site in United States are open now. Recruiting first, the newest first:
Calyxo, Inc. · Sites in United States
Ages 18+
YolTech Therapeutics Co., Ltd · Sites in United States
Ages 6+
Children's Hospital of Philadelphia · Sites in United States
Ages 6+
Ohio State University · Sites in United States
Ages 18+
Calyxo, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 88 Kidney Calculi studies recruiting now, 48 (55%) set no upper age limit and 23 (26%) stop at 75 or younger; 6 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
193 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 23 · Phase 3 9 · Phase 4 13
First in 1998; this study’s year is marked. 15 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 41 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Median enrollment 47 across the 165 interventional studies, 122 across the 28 observational. Of the 116 that completed or were terminated, 51 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 193 have an industry lead sponsor. The 10 most frequent:
Stanford University is the lead sponsor of 2,170 studies on the registry; 433 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Stanford University has 1 study filed under Kidney Calculi — fewer than ten, so there is no comparison to draw.
17 of the studies in Kidney Calculi with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07296835University of Kansas Medical CenterSurgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope | 2026-11 |
| NCT04651088University of Texas Southwestern Medical CenterComparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet | 2026-12 |
| NCT05993546The Cleveland ClinicRandomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis | 2026-12 |
| NCT04333745University of Alabama at BirminghamInfluence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers | 2026-12-01 |
| NCT04603898University of Alabama at BirminghamOxalate Formation From Ascorbic Acid | 2026-12-01 |
Add all 17 to your calendar (.ics) → With an account.
Among the 193 studies in Kidney Calculi with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will follow standard care until the ureteral stent is removed
Participants will use the TENS device until the ureteral stent is removed
Device: TENS
TENS device used four times a day for 60 minutes each time
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)
Time frame: 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)
Time frame: Assessed daily until removal of stent, approximately 3-10 days after placement
Total Opioid Consumption
Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire.
Time frame: Until stent removal (up to 10 days)
Difference in Total Opioid Consumption
Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: End of study (day 3 to 10)
| Milestone | TENS Device | Standard Care |
|---|---|---|
| Started | 17 | 13 |
| Completed | 17 | 11 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
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)
| score on a scale | TENS Device | Standard Care |
|---|---|---|
| Back Pain | 3.52 ± 3.08 | 3.42 ± 2.85 |
| Abdominal/Groin Pain | 4.44 ± 2.59 | 4.02 ± 2.44 |
| Pain Frequency | 4.70 ± 2.33 | 5.22 ± 2.28 |
| Nausea Intensity | 1.18 ± 1.63 | 1.98 ± 2.01 |
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)
| score on a scale | TENS Device | Standard Care |
|---|---|---|
| Back Pain | -3.94 ± 6.59 | -6.09 ± 10.29 |
| Abdominal/Groin Pain | -4.88 ± 9.55 | -8.54 ± 7.74 |
| Pain Frequency | -5.64 ± 7.52 | -8.63 ± 9.50 |
| Nausea Intensity | -1.05 ± 4.97 | -4.09 ± 7.58 |
Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire.
| MME | TENS Device | Standard Care |
|---|---|---|
| Total Opioid Consumption | 31.73 ± 66.08 | 17.27 ± 28.21 |
Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire.
| MME | TENS Device | Standard Care |
|---|---|---|
| Difference in Total Opioid Consumption | -5.03 ± 25.64 | 2.72 ± 31.23 |
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.
| score on a scale | TENS Device | Standard Care |
|---|---|---|
| Overall score | 30.23 ± 6.48 | 29.30 ± 11.02 |
| Urinary symptoms | 16.92 ± 4.89 | 16.00 ± 7.20 |
| Pain | 3.15 ± 1.52 | 2.70 ± 1.57 |
| Daily life | 2.54 ± 1.39 | 3.10 ± 1.91 |
| Sexual life | 0.08 ± 0.28 | 0.50 ± 1.58 |
| Medical care/analgesic use | 4.23 ± 2.17 | 3.60 ± 2.07 |
| Overall Quality of Life | 3.31 ± 1.32 | 3.40 ± 1.51 |
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.
| Participants | TENS Device |
|---|---|
| Preferred TENS device over medication | 9 |
| Would use TENS device in the future | 12 |
Collected over Up to 10 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TENS Device | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Standard Care | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
Participants who completed the protocol
| Age, Continuous(years) | TENS Device | Standard Care | Total |
|---|---|---|---|
| Mean | 52.94 ± 14.38 | 63.09 ± 15.79 | 56.92 ± 15.50 |
| Sex: Female, Male(Participants) | TENS Device | Standard Care | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 8 | 6 | 14 |
| Ethnicity (NIH/OMB)(Participants) | TENS Device | Standard Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 16 | 9 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | TENS Device | Standard Care | Total |
|---|---|---|---|
| Asian | 5 | 0 | 5 |
| African American | 1 | 0 | 1 |
| White | 8 | 9 | 17 |
| Other | 3 | 2 | 5 |
| Region of Enrollment(Participants) | TENS Device | Standard Care | Total |
|---|---|---|---|
| United States | 17 | 11 | 28 |
| Surgical Laterality(Participants) | TENS Device | Standard Care | Total |
|---|---|---|---|
| Right | 6 | 5 | 11 |
| Left | 11 | 6 | 17 |
| Stone Location(Participants) | TENS Device | Standard Care | Total |
|---|---|---|---|
| Ureteral | 8 | 3 | 11 |
| Renal | 8 | 5 | 13 |
| Both | 1 | 3 | 4 |
| Stent Length in cm(Participants) | TENS Device | Standard Care | Total |
|---|---|---|---|
| 20 | 3 | 1 | 4 |
| 22 | 4 | 0 | 4 |
| 24 | 5 | 5 | 10 |
| 26 | 5 | 4 | 9 |
| 28 | 0 | 1 | 1 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Oct 2023, 32 months.
Results were first posted in Oct 2024, 1 year after primary completion.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's 32 months is close to that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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