Urological SurgeryNCT07671612
PBM Patch for Postoperative Pain Relief After Urological Surgery
A study testing Super Vi PBM Patch - Soothing and Super Vi PBM Patch - Soothing EX in people with Urological Surgery and Photobiomodulation (PBM), run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urological Surgery, Photobiomodulation (PBM), Non-pharmacological Intervention
- What is being tested?
- Super Vi PBM Patch - Soothing and Super Vi PBM Patch - Soothing EX
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jul 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites
National Taiwan University Hospital
Taipei, Taipei City, 100
Shih-Chieh Chueh, M.D., +886-2-3123456 ext. 62135, scchueh@ntu.edu.tw
National Taiwan University Cancer Center
Taipei, Taipei City, 106
Wei-Che Wu, M.D., +886972652979, A01827@ntucc.gov.tw
About this study
Official title: A Double-blind Randomized Controlled Clinical Study of the PBM Patch for Postoperative Pain Relief After Urological Surgery
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).
- Conditions
- Urological Surgery, Photobiomodulation (PBM), Non-pharmacological Intervention, Double-blind Randomized Controlled Study, Postoperative Pain Relief
- Being tested
- Super Vi PBM Patch - Soothing, Super Vi PBM Patch - Soothing EX, Placebo Patch
- Keywords
- Postoperative Pain Relief, Photobiomodulation (PBM), Urological Surgery, Double-blind Randomized Controlled Study, Non-pharmacological Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Vi PBM Patch - SoothingDevice
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.
Super Vi PBM Patch - Soothing EXDevice
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.
Placebo PatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Super Vi PBM Patch - Soothing | Experimental | The Super Vi PBM Patch - Soothing will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery. Receives: Device: Super Vi PBM Patch - Soothing |
| Super Vi PBM Patch - Soothing EX | Experimental | The Super Vi PBM Patch - Soothing EX will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery. Receives: Device: Super Vi PBM Patch - Soothing EX |
| Placebo Patch | Placebo comparator | The Placebo Patch will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery. Receives: Device: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Comparison of the frequency and total dosage of analgesic use among the three groups within 120 hours postoperatively. Analgesics include non-opioids (e.g., Acetaminophen, NSAIDs) and opioids (e.g., Morphine, Tramadol). Opioid use will be converted to Morphine Milligram Equivalents (MME) for standardized comparison, in order to evaluate and verify the opioid-sparing effect of the study patch.
Measured: Up to 120 hours postoperatively
Proportion of Patients Achieving Patient Acceptable Symptom State (PASS)
Proportion of participants in each group achieving Patient Acceptable Symptom State (PASS), defined as a Visual Analogue Scale (VAS) pain score of ≤33 mm (scale: 0-100 mm; higher scores indicate worse pain) at 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, used to assess patient satisfaction with pain control.
Measured: 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
Time to first ambulation out of bed and length of postoperative hospital stay will be recorded and compared among the three groups, to evaluate whether patch treatment accelerates the clinical recovery process.
Measured: From end of surgery to hospital discharge, assessed up to 5 days postoperatively
Quality of Life Improvement
Change in quality of life from preoperative baseline to 120 hours postoperatively, assessed using the Traditional Chinese version of the EQ-5D-5L questionnaire (EuroQol 5-Dimension 5-Level). Higher index scores indicate better health-related quality of life. The EQ Visual Analogue Scale (EQ-VAS) will be reported as a supplementary measure, with higher scores indicating better self-rated health.
Measured: Baseline (preoperative) to 120 hours postoperatively
Safety Assessment
Detailed recording of all adverse events occurring during the study period, including patch-site skin reactions (e.g., erythema, itching, rash) and analgesic-related side effects (e.g., nausea, vomiting, dizziness).
Measured: Up to 120 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671612
- Sponsor's protocol ID
- 202603101DINA、202603107DINA
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet determined whether individual participant data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Clinical Study of the PBM Patch for Postoperative Pain Relief After Urological Surgery
- ClinicalTrials.gov ID
- NCT07671612
- Acronym / sponsor ID
- 202603101DINA、202603107DINA
- Conditions
- Urological Surgery, Photobiomodulation (PBM), Non-pharmacological Intervention, Double-blind Randomized Controlled Study, Postoperative Pain Relief
- Keywords
- Postoperative Pain Relief, Photobiomodulation (PBM), Urological Surgery, Double-blind Randomized Controlled Study, Non-pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Super Vi PBM Patch - Soothing | Experimental | Device: Super Vi PBM Patch - SoothingThe 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 | Experimental | Device: Super Vi PBM Patch - Soothing EXThe 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 comparator | Device: Placebo PatchThe Placebo Patch will be applied to the participant immediately upon arrival in the post-anesthesia care unit (PACU) after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super Vi PBM Patch - SoothingA 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. | Device | Super Vi PBM Patch - Soothing |
| Super Vi PBM Patch - Soothing EXA 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. | Device | Super Vi PBM Patch - Soothing EX |
| Placebo PatchAn 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. | Device | Placebo Patch |
Primary outcome
Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest
Time frame: Baseline (preoperatively), and 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours postoperatively
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.
5 secondary outcomes
Total Postoperative Analgesic Consumption
Time frame: Up to 120 hours postoperatively
Proportion of Patients Achieving Patient Acceptable Symptom State (PASS)
Time frame: 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
Time frame: From end of surgery to hospital discharge, assessed up to 5 days postoperatively
Quality of Life Improvement
Time frame: Baseline (preoperative) to 120 hours postoperatively
Safety Assessment
Time frame: Up to 120 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Undecided. It is not yet determined whether individual participant data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Vi PBM Patch - Soothing and Super Vi PBM Patch - Soothing EX in people with Urological Surgery and Photobiomodulation (PBM), run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shih-Chieh Chueh, Attending Physicia / Professor (+886-2-3123456 ext. 62135, scchueh@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-Weighted Mean Visual Analogue Scale (VAS) Pain Score at Rest (time frame: Baseline (preoperatively), and 1 hour ±30 minutes, 2±1 hours, 6±2 hours, 12±2 hours, and 24±2 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.