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 (&bgr; = 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,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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