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

Research output: Contribution to journalJournal articleResearchpeer-review

  • 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. Patient summary: This study evaluates the efficacy of outpatient laser removal of low-grade noninvasive bladder tumor. Outpatient tumor removal with laser was as good as transurethral resection in general anesthesia and less burdensome to patients.

Original languageEnglish
JournalEuropean Urology
Issue number2
Pages (from-to)125-130
Number of pages6
Publication statusPublished - 2023

Bibliographical note

Publisher Copyright:
© 2022 European Association of Urology

    Research areas

  • 4-mo recurrence-free survival, Bladder cancer, Diode laser, Laser treatment, Outpatient treatment, Quality of life, Ta low grade

ID: 337652911