Effect of Starting Penile Rehabilitation with Sildenafil Immediately after Robot-Assisted Laparoscopic Radical Prostatectomy on Erectile Function Recovery: A Prospective Randomized Trial

Abstract

PURPOSE: It has not been clearly proved in real practice whether early rehabilitation with phosphodiesterase type 5 inhibitors starting immediately after radical prostatectomy improves erectile function recovery more effectively than delayed treatment with the same regimen. We performed a prospective randomized trial to identify this. MATERIALS AND METHODS: Patients with prostate cancer and an IIEF-5 (International Index of Erectile Function-5) preoperative score of 17 or greater were randomly assigned to receive sildenafil 100 mg regularly twice per week for 3 months immediately after urethral catheter removal as the early group or only 3 months after nerve sparing robot-assisted laparoscopic radical prostatectomy as the delayed group. The study primary end point was the full erectile function recovery rate, defined as an IIEF-5 score of 17 or greater, during the 12 months. RESULTS: Of the 120 randomized patients the proportion who achieved full recovery was significantly higher during the 12 months in the early group than in the delayed group (β = 0.356, p <0.001, generalized estimating equation). After 9 months postoperatively the proportion of patients who achieved full recovery steadily increased to 41.4% at 12 months in the early group while patients in the delayed group showed no further improvement. Thus, full recovery was achieved in only 17.7% of patients at 12 months. Only early sildenafil treatment independently improved full recovery at 12 months (HR 2.943, p = 0.034). CONCLUSIONS: Our trial provides clinical data to suggest that earlier rehabilitation with phosphodiesterase type 5 inhibitors can contribute to the recovery of erectile function after radical prostatectomy in the clinical setting.