Transrectal and transurethral hyperthermia versus sham treatment in benign prostatic hyperplasia: a double‐blind randomized multicentre clinical trial

OBJECTIVE: To compare the safety and efficacy of hyperthermia for the treatment of benign prostatic hyperplasia (BPH), by either the transrectal or transurethral approach, relative to sham treatment. PATIENTS AND METHODS: Two hundred patients from seven urological departments were randomized and treated in a single centre. Principal inclusion criteria were a peak flow rate (PFR) < 15 mL/s and residual urine < 300 mL/s. Comparisons were made between transurethral hyperthermia (TUH) and transurethral sham (TUS) and between transrectal hyperthermia (TRH) and transrectal sham (TRS) 12 months after treatment. Outcome was assessed by improvements in the Madsen score and PFR, and the incidence of side-effects. RESULTS: After 12 months, 145 patients were evaluated; 12 patients withdrew during treatment, 43 withdrew during follow-up and two were lost to follow-up. Withdrawals were mainly due to side-effects during treatment (17% in the TRH and 1.5% in the TUH group) and to a lack of improvement during follow-up (14% in the TUH group, 19% in the TUS, 15% in the TRH and 10.5% in the TRS group received other treatments for BPH). Complications during treatment consisted mainly of local pain, urethral bleeding, urethral pain and acute retention, and were five times more frequent in the TRH than the TUH group (34% versus 6%). There was no improvement in PFR after TUH and TRH (response < 20%). Only TUH improved the Madsen score (TUH, +50% and TUS, +17%). CONCLUSION: Hyperthermia was not an effective treatment for BPH.