PBM Patch for Postoperative Pain Relief After Urological Surgery
A Double-blind Randomized Controlled Clinical Study of the PBM Patch for Postoperative Pain Relief After Urological Surgery
1 other identifier
interventional
300
1 country
2
Brief Summary
This study is a prospective, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of a photobiomodulation (PBM) patch (Super Vi PBM Patch - Soothing) and an enhanced PBM patch (Super Vi PBM Patch - Soothing EX), compared with a placebo patch, for postoperative pain relief following urological surgery, including nephroureterectomy with bladder cuff resection (NU+BCR) and adrenalectomy (ADRX).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
June 26, 2026
June 1, 2026
1.7 years
June 18, 2026
June 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest
The preoperative baseline VAS pain score at rest will be recorded before surgery. Postoperative VAS pain scores at rest will be assessed at 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours after surgery. The time-weighted mean VAS pain score at rest (Scale: 0-100 mm; higher scores indicate worse pain) during the first 24 hours postoperatively will be analyzed using a mixed model for repeated measures (MMRM). Sensitivity analysis will be performed using the area under the curve from baseline to 120 hours (AUC₀-₁₂₀h) with an analysis of covariance (ANCOVA) model.
Baseline (preoperatively), and 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours postoperatively
Secondary Outcomes (5)
Total Postoperative Analgesic Consumption
Up to 120 hours postoperatively
Proportion of Patients Achieving Patient Acceptable Symptom State (PASS)
1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, 24±2 hours, 48±2 hours, 72±2 hours, 96±2 hours, and 120±2 hours postoperatively
Clinical Recovery Progress
From end of surgery to hospital discharge, assessed up to 5 days postoperatively
Quality of Life Improvement
Baseline (preoperative) to 120 hours postoperatively
Safety Assessment
Up to 120 hours postoperatively
Study Arms (3)
Super Vi PBM Patch - Soothing
EXPERIMENTALThe Super Vi PBM Patch - Soothing will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery.
Super Vi PBM Patch - Soothing EX
EXPERIMENTALThe Super Vi PBM Patch - Soothing EX will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery.
Placebo Patch
PLACEBO COMPARATORThe Placebo Patch will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery.
Interventions
A photobiomodulation (PBM) patch designed for postoperative pain relief. The patch will be applied immediately upon arrival in the post-anesthesia care unit (PACU) after urological surgery.
A photobiomodulation (PBM) patch designed for postoperative pain relief. The patch will be applied immediately upon arrival in the post-anesthesia care unit (PACU) after urological surgery.
An placebo patch visually identical to the study patches but without therapeutic photobiomodulation delivery. The patch will be applied immediately upon arrival in the post-anesthesia care unit (PACU) after urological surgery.
Eligibility Criteria
You may qualify if:
- Patients aged 18 years or older undergoing unilateral nephroureterectomy with bladder cuff excision, or adrenalectomy (tumor size \< 3.5 cm).
- Patients who are capable of clear verbal communication.
- Patients who are able to provide written informed consent.
You may not qualify if:
- Individuals with photosensitive constitution or those currently using photosensitizing medications.
- Individuals with a known history of severe allergy or contact dermatitis to medical adhesive patches or tapes.
- Patients with severe psychiatric illness or cognitive impairment.
- Long-term or high-dose opioid users.
- Patients utilizing a Patient-Controlled Analgesia (PCA) pump.
- Individuals with severe hepatic insufficiency or active liver disease.
- Vulnerable populations, individuals with restricted legal capacity, or those who are unable or unwilling to undergo clinical evaluations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Taiwan University Hospital
Taipei, Taipei City, 100, Taiwan
National Taiwan University Cancer Center
Taipei, Taipei City, 106, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 26, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
June 26, 2026
Record last verified: 2026-06