Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin

Not yet recruiting

• Conditions: Benign Prostate Obstruction (BPO); Lower Urinary Tract Symptom; Ejaculatory Dysfunction; Anejaculation; Silodosin

• Registration Number: NCT06989515
• Lead Sponsor: Marmara University

Brief Summary

This observational study aims to evaluate the relationship between silodosin-induced anejaculation and clinical outcomes in male patients with benign prostatic obstruction (BPO). Silodosin is a commonly used alpha-blocker for lower urinary tract symptoms (LUTS). However, it may cause ejaculatory dysfunction, particularly anejaculation. In this study, patients receiving silodosin for the first time will be grouped based on whether they experience anejaculation or not. Treatment response will be assessed using urinary flow rate, post-void residual urine, and International Prostate Symptom Score (IPSS). Sexual function will be evaluated using the International Index of Erectile Function-5 (IIEF-5) before and after treatment. The study aims to explore whether the presence of anejaculation is associated with improved symptom relief or differences in sexual health.

Detailed Description

This is a observational study designed to investigate the association between silodosin-induced anejaculation and clinical outcomes in patients diagnosed with benign prostatic obstruction (BPO). Silodosin is an alpha-1A adrenergic receptor antagonist frequently used in the treatment of lower urinary tract symptoms (LUTS) secondary to BPO. One of the common adverse effects of silodosin is ejaculatory dysfunction, particularly anejaculation or retrograde ejaculation.

In this study, male patients over 40 years of age who are newly prescribed silodosin (8 mg/day) for LUTS will be enrolled. Baseline assessments will include serum PSA levels, prostate volume measurement via ultrasonography, uroflowmetry, post-void residual (PVR) urine volume, the International Prostate Symptom Score (IPSS), and the International Index of Erectile Function-5 (IIEF-5). These assessments will be repeated at the first routine follow-up visit, approximately one month after treatment initiation.

Patients will be divided into two groups based on the presence or absence of anejaculation. The primary objective is to compare changes in LUTS-related parameters (IPSS, uroflowmetry, PVR) and erectile function (IIEF-5 scores) between the two groups. This study will help determine whether anejaculation, a common side effect of silodosin, correlates with improved therapeutic response or changes in sexual health outcomes.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study Start: 2025-05-15
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Male patients aged 40 years or older
• Diagnosed with lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO)
• Initiating silodosin 8 mg/day therapy for the first time
• Able to complete IPSS and IIEF-5 questionnaires
• Willing and able to provide written informed consent

Exclusion Criteria

• History of prior treatment with silodosin or other α-blockers in the last 3 months
• Known neurogenic bladder or history of neurological disease affecting voiding
• History of prostate surgery or pelvic radiation
• Diagnosed prostate or bladder malignancy
• Use of medications affecting sexual function (e.g., PDE5 inhibitors) within the last month
• Severe cardiovascular, hepatic, or renal comorbidities
• Cognitive impairment preventing informed consent or questionnaire completion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in International Prostate Symptom Score (IPSS)	Baseline and 1 Month	IPSS will be measured at baseline and after 1 month of silodosin therapy. The change in score will be compared between patients who develop anejaculation and those who do not.
Change in Maximum Urinary Flow Rate (Qmax)	Baseline and 1 Month	Qmax will be measured via uroflowmetry at baseline and 1 month. Changes will be compared between the two groups.

Secondary Outcome Measures

Name	Time	Method
Change in Erectile Function (IIEF-5 Score)	Baseline and 1 Month	Erectile function will be assessed using the IIEF-5 questionnaire at baseline and at 1 month. Changes will be compared between groups.
Change in Post-Void Residual Urine Volume (PVR)	Baseline and 1 Month	PVR volume will be measured by ultrasonography at baseline and at 1 month. Changes will be analyzed between patients with and without anejaculation.