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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | TENS device used four times a day for 60 minutes each time |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| Assessed daily until removal of stent, approximately 3-10 days after placement |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire. | Until stent removal (up to 10 days) |
| Difference in Total Opioid Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Conti, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Stanford | California | 94305 | United States |
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41 participant signed consent; 30 were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | TENS Device | Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed |
| FG001 | Standard Care | Participants follow standard care until the ureteral stent is removed |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | TENS Device | Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed |
| BG001 | Standard Care | Participants follow standard care until the ureteral stent is removed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Participants who completed the protocol | Posted | Mean | Standard Deviation | score on a scale | Assessed daily until removal of stent, approximately 3-10 days after placement |
|
Up to 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TENS Device | Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon Conti, MD | Stanford University | 650-723-3391 | sconti@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2022 | Sep 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D014514 | Ureteral Calculi |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire.
| 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. | 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. | End of study (day 3 to 10) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Surgical Laterality | Count of Participants | Participants |
|
| Stone Location | Count of Participants | Participants |
|
| Stent Length in cm | Count of Participants | Participants |
|
| Concomitant Anxiety/Depression | Count of Participants | Participants |
|
| Standard Care |
Participants follow standard care until the ureteral stent is removed |
|
|
|
| Primary | 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:
| Participants who completed the protocol | Posted | Mean | Standard Deviation | score on a scale | Assessed daily until removal of stent, approximately 3-10 days after placement |
|
|
|
|
| Secondary | Total Opioid Consumption | Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire. | Participants who completed the protocol | Posted | Mean | Standard Deviation | MME | Until stent removal (up to 10 days) |
|
|
|
|
| Secondary | Difference in Total Opioid Consumption | Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire. | Participants who completed the protocol | Posted | Mean | Standard Deviation | MME | Until stent removal (up to 10 days) |
|
|
|
|
| Secondary | 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. | Participants who completed the USDT | Posted | Mean | Standard Deviation | score on a scale | Assessed at removal of stent, approximately 3-10 days after placement |
|
|
|
|
| Secondary | 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. | Participants who received the TENS device and completed the survey questions | Posted | Count of Participants | Participants | End of study (day 3 to 10) |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Standard Care | Participants follow standard care until the ureteral stent is removed | 0 | 13 | 0 | 13 | 0 | 13 |
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| Pain Frequency |
|
| Nausea Intensity |
|
| t-test, 2 sided |
| 0.28 |
A p-value less than the a priori threshold of 0.05 is considered statistically significant. |
| Other |
| Analysis of difference in pain frequency. | t-test, 2 sided | 0.39 | A p-value less than the a priori threshold of 0.05 is considered statistically significant. | Other |
| Analysis of difference in nausea intensity. | t-test, 2 sided | 0.26 | A p-value less than the a priori threshold of 0.05 is considered statistically significant. | Other |
| Pain |
|
| Daily life |
|
| Sexual life |
|
| Medical care/analgesic use |
|
| Overall Quality of Life |
|
| t-test, 2 sided |
| 0.72 |
A p-value less than the a priori threshold of 0.05 is considered statistically significant. |
| Other |
| Analysis of pain. | t-test, 2 sided | 0.45 | A p-value less than the a priori threshold of 0.05 is considered statistically significant. | Other |
| Analysis of daily life. | t-test, 2 sided | 0.42 | A p-value less than the a priori threshold of 0.05 is considered statistically significant. | Other |
| Analysis of sexual life. | t-test, 2 sided | 0.36 | A p-value less than the a priori threshold of 0.05 is considered statistically significant. | Other |
| Analysis of medical care/analgesic use. | t-test, 2 sided | 0.49 | A p-value less than the a priori threshold of 0.05 is considered statistically significant. | Other |
| Analysis of overall quality of life. | t-test, 2 sided | 0.88 | A p-value less than the a priori threshold of 0.05 is considered statistically significant. | Other |