Trial Outcomes & Findings for Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy (NCT NCT05153629)

Last Updated: 2024-10-22

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

Assessed daily until removal of stent, approximately 3-10 days after placement

Results posted on

2024-10-22

Participant Flow

41 participant signed consent; 30 were randomized

Participant milestones

Participant milestones
Measure	TENS Device Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care Participants follow standard care until the ureteral stent is removed
Overall Study STARTED	17	13
Overall Study COMPLETED	17	11
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TENS Device Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care Participants follow standard care until the ureteral stent is removed
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TENS Device n=17 Participants Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care n=11 Participants Participants follow standard care until the ureteral stent is removed	Total n=28 Participants Total of all reporting groups
Age, Continuous	52.94 years STANDARD_DEVIATION 14.38 • n=5 Participants	63.09 years STANDARD_DEVIATION 15.79 • n=7 Participants	56.92 years STANDARD_DEVIATION 15.50 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Surgical Laterality Right	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Surgical Laterality Left	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Stone Location Ureteral	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Stone Location Renal	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Stone Location Both	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Stent Length in cm 20	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Stent Length in cm 22	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Stent Length in cm 24	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Stent Length in cm 26	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Stent Length in cm 28	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Concomitant Anxiety/Depression	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed daily until removal of stent, approximately 3-10 days after placement

Population: Participants who completed the protocol

Outcome measures

Outcome measures
Measure	TENS Device n=17 Participants Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care n=11 Participants Participants follow standard care until the ureteral stent is removed
Pain on 11-point Visual Analog Score Scale (VAS) Back Pain	3.52 score on a scale Standard Deviation 3.08	3.42 score on a scale Standard Deviation 2.85
Pain on 11-point Visual Analog Score Scale (VAS) Abdominal/Groin Pain	4.44 score on a scale Standard Deviation 2.59	4.02 score on a scale Standard Deviation 2.44
Pain on 11-point Visual Analog Score Scale (VAS) Pain Frequency	4.70 score on a scale Standard Deviation 2.33	5.22 score on a scale Standard Deviation 2.28
Pain on 11-point Visual Analog Score Scale (VAS) Nausea Intensity	1.18 score on a scale Standard Deviation 1.63	1.98 score on a scale Standard Deviation 2.01

PRIMARY outcome

Timeframe: Assessed daily until removal of stent, approximately 3-10 days after placement

Population: Participants who completed the protocol

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)

Outcome measures

Outcome measures
Measure	TENS Device n=17 Participants Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care n=11 Participants Participants follow standard care until the ureteral stent is removed
Difference in Pain on 11-point Visual Analog Score Scale (VAS) Back Pain	-3.94 score on a scale Standard Deviation 6.59	-6.09 score on a scale Standard Deviation 10.29
Difference in Pain on 11-point Visual Analog Score Scale (VAS) Abdominal/Groin Pain	-4.88 score on a scale Standard Deviation 9.55	-8.54 score on a scale Standard Deviation 7.74
Difference in Pain on 11-point Visual Analog Score Scale (VAS) Pain Frequency	-5.64 score on a scale Standard Deviation 7.52	-8.63 score on a scale Standard Deviation 9.50
Difference in Pain on 11-point Visual Analog Score Scale (VAS) Nausea Intensity	-1.05 score on a scale Standard Deviation 4.97	-4.09 score on a scale Standard Deviation 7.58

SECONDARY outcome

Timeframe: Until stent removal (up to 10 days)

Population: Participants who completed the protocol

Consumption in morphine milligram equivalents (MME), based on patient-self-report in Daily Symptom Questionnaire.

Outcome measures

Outcome measures
Measure	TENS Device n=17 Participants Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care n=11 Participants Participants follow standard care until the ureteral stent is removed
Total Opioid Consumption	31.73 MME Standard Deviation 66.08	17.27 MME Standard Deviation 28.21

SECONDARY outcome

Timeframe: Until stent removal (up to 10 days)

Population: Participants who completed the protocol

Consumption (in MME), based on patient-self-report in Daily Symptom Questionnaire.

Outcome measures

Outcome measures
Measure	TENS Device n=17 Participants Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care n=11 Participants Participants follow standard care until the ureteral stent is removed
Difference in Total Opioid Consumption	-5.03 MME Standard Deviation 25.64	2.72 MME Standard Deviation 31.23

SECONDARY outcome

Timeframe: Assessed at removal of stent, approximately 3-10 days after placement

Population: Participants who completed the USDT

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.

Outcome measures

Outcome measures
Measure	TENS Device n=13 Participants Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care n=10 Participants Participants follow standard care until the ureteral stent is removed
Ureteral Stent Discomfort Test (USDT) Scale Score Overall score	30.23 score on a scale Standard Deviation 6.48	29.30 score on a scale Standard Deviation 11.02
Ureteral Stent Discomfort Test (USDT) Scale Score Urinary symptoms	16.92 score on a scale Standard Deviation 4.89	16.00 score on a scale Standard Deviation 7.20
Ureteral Stent Discomfort Test (USDT) Scale Score Pain	3.15 score on a scale Standard Deviation 1.52	2.70 score on a scale Standard Deviation 1.57
Ureteral Stent Discomfort Test (USDT) Scale Score Daily life	2.54 score on a scale Standard Deviation 1.39	3.10 score on a scale Standard Deviation 1.91
Ureteral Stent Discomfort Test (USDT) Scale Score Sexual life	0.08 score on a scale Standard Deviation 0.28	0.50 score on a scale Standard Deviation 1.58
Ureteral Stent Discomfort Test (USDT) Scale Score Medical care/analgesic use	4.23 score on a scale Standard Deviation 2.17	3.60 score on a scale Standard Deviation 2.07
Ureteral Stent Discomfort Test (USDT) Scale Score Overall Quality of Life	3.31 score on a scale Standard Deviation 1.32	3.40 score on a scale Standard Deviation 1.51

SECONDARY outcome

Timeframe: End of study (day 3 to 10)

Population: Participants who received the TENS device and completed the survey questions

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.

Outcome measures

Outcome measures
Measure	TENS Device n=13 Participants Participants use the TENS device (four times a day for 60 minutes each time) until the ureteral stent is removed	Standard Care Participants follow standard care until the ureteral stent is removed
Patient Satisfaction Survey Preferred TENS device over medication	9 Participants	—
Patient Satisfaction Survey Would use TENS device in the future	12 Participants	—

Adverse Events

TENS Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Simon Conti, MD

Stanford University

Phone: 650-723-3391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place