Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin

Marmara University

Status

Not yet enrolling

Conditions

Anejaculation

Ejaculatory Dysfunction

Lower Urinary Tract Symptom

Silodosin

Benign Prostate Obstruction (BPO)

Study type

Observational

Funder types

Other

Identifiers

NCT06989515

MAR.UAD.0023

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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