TRANSRECTAL AND TRANSURETHRAL HYPERTHERMIA VERSUS SHAM TREATMENT IN BENIGN PROSTATIC HYPERPLASIA - A DOUBLE-BLIND RANDOMIZED MULTICENTER CLINICAL-TRIAL

Objective To compare the safety and efficacy of hyperthermia for the t reatment of benign prostatic hyperplasia (BPH), by either the transrec tal or transurethral approach, relative to sham treatment. Patients an d methods. Two hundred patients from seven urological departments were randomized and treated in a single centre. Principal inclusion criter ia were a peak flow rate (PFR) <15 mL/s and residual urine <300 mL/s, Comparisons were made between transurethral hyperthermia (TUH) and tra nsurethral sham (TUS) and between transrectal hyperthermia (TRH) and t ransrectal sham (TRS) 12 months after treatment , Outcome was assessed by improvements in the Madsen score and PFR, and the incidence of sid e-effects. Results After 12 months, 145 patients were evaluated; 12 pa tients withdrew during treatment, 43 withdrew during follow-up and two were lost to follow-up, Withdrawals were mainly due to side-effects d uring treatment (17% in the TRH and 1.5% in the TUH group) and to a la ck of improvement during followup (14% in the TUH group, 19% in the TU S, 15% in the TRH and 10.5% in the TRS group received other treatments for BPH). Complications during treatment consisted mainly of local pa in, urethral bleeding, urethral pain and acute retention, and were fiv e times more frequent in the TRH than the TUH group (34% versus 6%), T here 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.