Outpatient Photodynamic Diagnosis–guided Laser Destruction of Bladder Tumors Is as Good as Conventional Inpatient Photodynamic Diagnosis–guided Transurethral Tumor Resection in Patients with Recurrent Intermediate-risk Low-grade Ta Bladder Tumors: A Prospective Randomized Noninferiority Clinical Trial

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

  • Gyrithe Lynghøj Pedersen
  • Marie Schmidt Erikson
  • Karin Mogensen
  • Rosthøj, Susanne
  • Gregers Gautier Hermann
Background
Transurethral resection of recurrent low-grade intermediate-risk Ta bladder tumor (BT) in general anesthesia (GA) is burdensome to patients and health care system. Laser technologies enable treatment in office-based settings, reducing morbidity and costs.

Objective
To compare 4-mo recurrence-free survival after outpatient department (OPD) diode laser coagulation of BT in local anesthesia and gold standard transurethral resection of BT (TUR-BT) in GA in intermediate-risk Ta low-grade BT, and to evaluate treatment-related morbidity.

Design, setting, and participants
A prospective randomized noninferiority trial with 4-mo follow-up, in the hospital setting, was conducted in Capital Region of Denmark from 2016 to 2020. Participants were patients with histologically verified Ta low-grade BT recurrence. A total of 206 patients were randomized; 176 finished treatment and follow-up as per protocol.

Intervention
Laser photocoagulation of bladder tumor (PC-BT) in OPD using a 980 nm diode laser compared with gold standard TUR-BT in GA, both performed with photodynamic diagnosis (PDD) guidance.

Outcome measurements and statistical analysis
Four-month recurrence-free survival was assessed; predefined inferiority criterion was set at 15%. The secondary outcomes were pain during PC-BT, postoperative morbidity, postoperative complications, and patient’s preference.

Results and limitations
Four-month recurrence-free survival was 8% higher after PC-BT (95% confidence interval [CI]: –8% to 24%). The predefined noninferiority criterion was met. Pain score (1–10) during PC-BT was 2.4 (interquartile range 0.8–3.3). Postoperative lower urinary tract symptom score (0–100) was 13.9 points higher (95% CI: 6.9–21.0, p < 0.001) in the group with transurethral resection of the bladder. The frequency of minor complications was 8.1% higher after TUR-BT (95% CI: 1.0–14.6%, p = 0.026). Of the patients, 98% (95% CI: 92–100%) preferred PC-BT.

Conclusions
PDD-guided PC-BT in OPD is as good as TUR-BT in GA to remove recurrent low-grade Ta BT. Postoperative quality of life is better after PC-BT and the frequency of minor complications was lower.
OriginalsprogEngelsk
TidsskriftEuropean Urology
Vol/bind83
Udgave nummer2
Sider (fra-til)125-130
Antal sider6
ISSN0302-2838
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
Funding/Support and role of the sponsor: The study was sponsored by Fondation Juchum, Photocure ASA, A.R.C. Laser, Biolitec, and Karl Storz. None of the sponsors was involved in design or conduct of the study, or writing or approval of manuscript.

Publisher Copyright:
© 2022 European Association of Urology

ID: 337652911