Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin

NCT ID: NCT06989515

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-15

Study Completion Date

2026-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostate Obstruction (BPO) Lower Urinary Tract Symptom Ejaculatory Dysfunction Anejaculation Silodosin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anejaculation

Male patients who develop anejaculation after initiating silodosin treatment for benign prostatic obstruction (BPO).

No interventions assigned to this group

Non-Anejaculation

Male patients who do not develop anejaculation during silodosin treatment for benign prostatic obstruction (BPO).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Marmara University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tarik Emre Sener

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

günal özgür, Urology Specialist

Role: CONTACT

+905357849485

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MAR.UAD.0023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.