Conditions: Erectile Dysfunction Lower Urinary Tract Symptoms
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 74
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).

Detailed description:
This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.

Arms:
arm 1: Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks. arm 2: Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks.

Interventions: intervention 1: Placebo intervention 2: Alfuzosin
Intervention descriptions: intervention 1: Alfuzosin-matched One tablet once daily intervention 2: 10 mg once daily

Protocol document: