Study Comparing Two Rehabilitation Approaches for Erectile Function Recovery After Nerve-Sparing Robotic Prostate Cancer Surgery

What this Trial Is About

Researchers are evaluating two different rehabilitation approaches to improve recovery of erectile function in men who have undergone nerve-sparing robot-assisted radical prostatectomy for localized prostate cancer. This randomized trial aims to find the best penile rehabilitation strategy to reduce postoperative erectile dysfunction, which remains common despite nerve-sparing surgery. The study is conducted at multiple centers in the Netherlands and focuses on patients aged 18 to 70 years with non-metastatic prostate cancer. Participants will be randomly assigned to one of two groups one receiving a daily dose of 75-100 mg Sildenafil combined with vacuum device therapy for 10 minutes a day, five times a week, for 12 months and the other receiving on-demand Sildenafil therapy up to three times per week. After the first year, treatment intensity may be adjusted for an additional year using on-demand Sildenafil, vacuum device therapy, or optional intracavernosal injection therapy, depending on patient preference. The study treatment period lasts 24 months, concluding with a one-month drug washout before final assessments. Participants will attend baseline and follow-up evaluations every three months via phone, online surveys, and outpatient clinic visits lasting about 20 minutes. They will complete questionnaires on sexual function and quality of life and provide one blood sample at baseline for hormone and metabolic testing. Researchers will monitor erectile function over 24 months using validated questionnaires, assess side effects, adherence, and quality of life. The primary outcome is recovery of an adequate unassisted erection at 24 months post-surgery.

PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)