Study of Tadalafil 5mg Daily to Improve Early Urinary Symptoms and Erectile Dysfunction After Endoscopic Prostate Surgery in Men Aged 40 to 80

What this Trial Is About

This research aims to evaluate the use of Tadalafil, a medication, for improving early storage symptoms and erectile dysfunction in men after endoscopic enucleation of the prostate, a surgery for benign prostatic hyperplasia BPH. BPH causes bothersome lower urinary tract symptoms LUTS such as frequent urination, urgency, and nocturia, which can be linked to erectile dysfunction. Despite surgical relief of obstruction, some men experience persistent or worsening symptoms, possibly due to irreversible damage from underlying mechanisms. The study investigates whether Tadalafil can help relieve these symptoms and support erectile function recovery. Participants who have undergone Holmium laser enucleation of the prostate HoLEP will be randomly assigned to receive either a daily 5 mg dose of Tadalafil or a placebo for three months. The study compares these two groups to assess the effectiveness of Tadalafil in reducing persistent or new storage symptoms and early decline in erectile function after surgery. The treatment phase lasts three months, followed by an additional three-month follow-up to observe symptom durability and recovery. During the study, participants will complete questionnaires measuring erectile function and prostate symptoms at multiple time points 2 weeks, 1 month, 3 months during treatment, and 6 months after surgery. The primary outcome focuses on orgasm perception using the International Index of Erectile Function IIEF-15. Secondary outcomes include changes in the International Prostate Symptom Score IPSS, assessing voiding and storage symptoms. Safety and quality of life will be monitored throughout the study period, which spans six months from surgery to final follow-up.

Efficacy of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Endoscopic Enucleation of Prostate