N/A
N=30
Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy
Kidney Stone · Ureteral Calculi · Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT05153629 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Pain on 11-point Visual Analog Score Scale (VAS) — 3.52; 3.42; 4.44; 4.02 score on a scale — p=0.93
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TENS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain on 11-point Visual Analog Score Scale (VAS) |
3.52; 3.42; 4.44; 4.02; 4.70; 5.22 | 0.93 |
| PRIMARY Difference in Pain on 11-point Visual Analog Score Scale (VAS) |
-3.94; -6.09; -4.88; -8.54; -5.64; -8.63 | 0.55 |
| SECONDARY Total Opioid Consumption |
31.73; 17.27 | 0.50 |
| SECONDARY Difference in Total Opioid Consumption |
-5.03; 2.72 | 0.50 |
| SECONDARY Ureteral Stent Discomfort Test (USDT) Scale Score |
30.23; 29.30; 16.92; 16.00; 3.15; 2.70 | 0.80 |
| SECONDARY Patient Satisfaction Survey |
9; 12 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05153629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.