Early Use of Sildenafil to Prevent Erectile Dysfunction After Radiotherapy and Surgery for Rectal Cancer in Men Aged 18 to 70

What this Trial Is About

This research aims to evaluate the use of sildenafil for erectile rehabilitation in men treated with neoadjuvant radiotherapy and proctectomy for rectal cancer. The study focuses on preventing long-term erectile dysfunction, a common complication after surgery and radiotherapy, which affects quality of life. The mechanisms causing erectile dysfunction include nerve injury during surgery and vascular damage from radiotherapy, leading to tissue changes and fibrosis that may become permanent without early intervention. Participants are randomly assigned to receive either sildenafil 50 mg daily or a placebo for 10 months, starting 30 days after surgery. The study compares these two groups to assess the potential benefits of early erectile rehabilitation. The trial uses a triple-blind design and follows patients over a year postoperatively to monitor erectile function and other health outcomes. During the study, participants undergo regular evaluations at baseline, 1, 3, 6, 9, and 12 months after surgery. Assessments include erectile function scores, quality of life, bowel function, psychological support, treatment adherence, and monitoring for adverse events. The primary outcome is the patients erectile response 12 months after surgery, with ongoing safety and effectiveness evaluations throughout the study period.

Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer