Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin

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.

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Key information

Conditions

Benign Prostate Obstruction (BPO) Anejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptom Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Signs and Symptoms Silodosin Urogenital Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in International Prostate Symptom Score (IPSS)

Time frame: 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)

Time frame: Baseline and 1 Month

Qmax will be measured via uroflowmetry at baseline and 1 month. Changes will be compared between the two groups.

Secondary outcomes

Change in Erectile Function (IIEF-5 Score)

Time frame: 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)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

günal özgür, Urology Specialist

CONTACT

[email protected]

+905357849485

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Does Anejaculation Reflect Better Clinical Outcomes in BPO Patients Receiving Silodosin?

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 25, 2025
Registry last updated: Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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