Kidney Stone, Nephrolithiasis, Ureteral Calculi
Conditions
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.
Interventions
DEVICETENS
TENS device used four times a day for 60 minutes each time
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
41 participant signed consent; 30 were randomized
Participants by arm
| Arm | Count |
|---|---|
| TENS Device Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed | 17 |
| Standard Care Participants follow standard care until the ureteral stent is removed | 11 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | TENS Device | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 52.94 years STANDARD_DEVIATION 14.38 | 63.09 years STANDARD_DEVIATION 15.79 | 56.92 years STANDARD_DEVIATION 15.5 |
| Concomitant Anxiety/Depression | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 9 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 9 Participants | 17 Participants |
| Region of Enrollment United States | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
| Stent Length in cm 20 | 3 Participants | 1 Participants | 4 Participants |
| Stent Length in cm 22 | 4 Participants | 0 Participants | 4 Participants |
| Stent Length in cm 24 | 5 Participants | 5 Participants | 10 Participants |
| Stent Length in cm 26 | 5 Participants | 4 Participants | 9 Participants |
| Stent Length in cm 28 | 0 Participants | 1 Participants | 1 Participants |
| Stone Location Both | 1 Participants | 3 Participants | 4 Participants |
| Stone Location Renal | 8 Participants | 5 Participants | 13 Participants |
| Stone Location Ureteral | 8 Participants | 3 Participants | 11 Participants |
| Surgical Laterality Left | 11 Participants | 6 Participants | 17 Participants |
| Surgical Laterality Right | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 13 |
| other Total, other adverse events | 0 / 17 | 0 / 13 |
| serious Total, serious adverse events | 0 / 17 | 0 / 13 |
Outcome results
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: * 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
Population: Participants who completed the protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENS Device | Difference in Pain on 11-point Visual Analog Score Scale (VAS) | Back Pain | -3.94 score on a scale | Standard Deviation 6.59 |
| TENS Device | Difference in Pain on 11-point Visual Analog Score Scale (VAS) | Pain Frequency | -5.64 score on a scale | Standard Deviation 7.52 |
| TENS Device | Difference in Pain on 11-point Visual Analog Score Scale (VAS) | Nausea Intensity | -1.05 score on a scale | Standard Deviation 4.97 |
| TENS Device | Difference in Pain on 11-point Visual Analog Score Scale (VAS) | Abdominal/Groin Pain | -4.88 score on a scale | Standard Deviation 9.55 |
| Standard Care | Difference in Pain on 11-point Visual Analog Score Scale (VAS) | Nausea Intensity | -4.09 score on a scale | Standard Deviation 7.58 |
| Standard Care | Difference in Pain on 11-point Visual Analog Score Scale (VAS) | Back Pain | -6.09 score on a scale | Standard Deviation 10.29 |
| Standard Care | Difference in Pain on 11-point Visual Analog Score Scale (VAS) | Abdominal/Groin Pain | -8.54 score on a scale | Standard Deviation 7.74 |
| Standard Care | Difference in Pain on 11-point Visual Analog Score Scale (VAS) | Pain Frequency | -8.63 score on a scale | Standard Deviation 9.5 |
Comparison: Analysis of difference in back pain.p-value: 0.55t-test, 2 sided
Comparison: Analysis of difference in abdominal/groin pain.p-value: 0.28t-test, 2 sided
Comparison: Analysis of difference in pain frequency.p-value: 0.39t-test, 2 sided
Comparison: Analysis of difference in nausea intensity.p-value: 0.26t-test, 2 sided
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: * 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
Population: Participants who completed the protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENS Device | Pain on 11-point Visual Analog Score Scale (VAS) | Back Pain | 3.52 score on a scale | Standard Deviation 3.08 |
| TENS Device | Pain on 11-point Visual Analog Score Scale (VAS) | Abdominal/Groin Pain | 4.44 score on a scale | Standard Deviation 2.59 |
| TENS Device | Pain on 11-point Visual Analog Score Scale (VAS) | Pain Frequency | 4.70 score on a scale | Standard Deviation 2.33 |
| TENS Device | Pain on 11-point Visual Analog Score Scale (VAS) | Nausea Intensity | 1.18 score on a scale | Standard Deviation 1.63 |
| Standard Care | Pain on 11-point Visual Analog Score Scale (VAS) | Nausea Intensity | 1.98 score on a scale | Standard Deviation 2.01 |
| Standard Care | Pain on 11-point Visual Analog Score Scale (VAS) | Back Pain | 3.42 score on a scale | Standard Deviation 2.85 |
| Standard Care | Pain on 11-point Visual Analog Score Scale (VAS) | Pain Frequency | 5.22 score on a scale | Standard Deviation 2.28 |
| Standard Care | Pain on 11-point Visual Analog Score Scale (VAS) | Abdominal/Groin Pain | 4.02 score on a scale | Standard Deviation 2.44 |
Comparison: Analysis of back pain.p-value: 0.93t-test, 2 sided
Comparison: Analysis of abdominal/groin pain.p-value: 0.76t-test, 2 sided
Comparison: Analysis of pain frequency.p-value: 0.56t-test, 2 sided
Comparison: Analysis of nausea intensity.p-value: 0.26t-test, 2 sided
Secondary
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)
Population: Participants who completed the protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TENS Device | Difference in Total Opioid Consumption | -5.03 MME | Standard Deviation 25.64 |
| Standard Care | Difference in Total Opioid Consumption | 2.72 MME | Standard Deviation 31.23 |
p-value: 0.5t-test, 2 sided
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.
Time frame: End of study (day 3 to 10)
Population: Participants who received the TENS device and completed the survey questions
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TENS Device | Patient Satisfaction Survey | Preferred TENS device over medication | 9 Participants |
| TENS Device | Patient Satisfaction Survey | Would use TENS device in the future | 12 Participants |
Secondary
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)
Population: Participants who completed the protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TENS Device | Total Opioid Consumption | 31.73 MME | Standard Deviation 66.08 |
| Standard Care | Total Opioid Consumption | 17.27 MME | Standard Deviation 28.21 |
p-value: 0.5t-test, 2 sided
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.
Time frame: Assessed at removal of stent, approximately 3-10 days after placement
Population: Participants who completed the USDT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENS Device | Ureteral Stent Discomfort Test (USDT) Scale Score | Overall Quality of Life | 3.31 score on a scale | Standard Deviation 1.32 |
| TENS Device | Ureteral Stent Discomfort Test (USDT) Scale Score | Overall score | 30.23 score on a scale | Standard Deviation 6.48 |
| TENS Device | Ureteral Stent Discomfort Test (USDT) Scale Score | Urinary symptoms | 16.92 score on a scale | Standard Deviation 4.89 |
| TENS Device | Ureteral Stent Discomfort Test (USDT) Scale Score | Pain | 3.15 score on a scale | Standard Deviation 1.52 |
| TENS Device | Ureteral Stent Discomfort Test (USDT) Scale Score | Daily life | 2.54 score on a scale | Standard Deviation 1.39 |
| TENS Device | Ureteral Stent Discomfort Test (USDT) Scale Score | Sexual life | 0.08 score on a scale | Standard Deviation 0.28 |
| TENS Device | Ureteral Stent Discomfort Test (USDT) Scale Score | Medical care/analgesic use | 4.23 score on a scale | Standard Deviation 2.17 |
| Standard Care | Ureteral Stent Discomfort Test (USDT) Scale Score | Overall Quality of Life | 3.40 score on a scale | Standard Deviation 1.51 |
| Standard Care | Ureteral Stent Discomfort Test (USDT) Scale Score | Daily life | 3.10 score on a scale | Standard Deviation 1.91 |
| Standard Care | Ureteral Stent Discomfort Test (USDT) Scale Score | Overall score | 29.30 score on a scale | Standard Deviation 11.02 |
| Standard Care | Ureteral Stent Discomfort Test (USDT) Scale Score | Medical care/analgesic use | 3.60 score on a scale | Standard Deviation 2.07 |
| Standard Care | Ureteral Stent Discomfort Test (USDT) Scale Score | Urinary symptoms | 16.00 score on a scale | Standard Deviation 7.2 |
| Standard Care | Ureteral Stent Discomfort Test (USDT) Scale Score | Sexual life | 0.50 score on a scale | Standard Deviation 1.58 |
| Standard Care | Ureteral Stent Discomfort Test (USDT) Scale Score | Pain | 2.70 score on a scale | Standard Deviation 1.57 |
Comparison: Analysis of overall USDT score.p-value: 0.8t-test, 2 sided
Comparison: Analysis of urinary symptoms.p-value: 0.72t-test, 2 sided
Comparison: Analysis of pain.p-value: 0.45t-test, 2 sided
Comparison: Analysis of daily life.p-value: 0.42t-test, 2 sided
Comparison: Analysis of sexual life.p-value: 0.36t-test, 2 sided
Comparison: Analysis of medical care/analgesic use.p-value: 0.49t-test, 2 sided
Comparison: Analysis of overall quality of life.p-value: 0.88t-test, 2 sided