Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin

NCT06989515 | Not Yet Recruiting

• 1 other identifier: MAR.UAD.0023
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Silodosin; Ejaculatory Dysfunction; Benign Prostatic Obstruction; Lower Urinary Tract Symptoms; Alpha-blocker Side Effects

Outcome Measures

Primary Outcomes (2)

• Change in International Prostate Symptom Score (IPSS)

  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.

  Baseline and 1 Month

• Change in Maximum Urinary Flow Rate (Qmax)

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

  Baseline and 1 Month

Secondary Outcomes (2)

• Change in Erectile Function (IIEF-5 Score)

  Baseline and 1 Month

• Change in Post-Void Residual Urine Volume (PVR)

  Baseline and 1 Month

Study Arms (2)

Anejaculation

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

Non-Anejaculation

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

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients aged 40 years and older presenting with lower urinary tract symptoms due to benign prostatic obstruction (BPO), who are newly prescribed silodosin therapy and have no prior history of prostate surgery or neurogenic bladder dysfunction.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Ejaculatory Dysfunction

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Central Study Contacts

günal özgür, Urology Specialist

CONTACT

+905357849485; gunalozgur91@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 25, 2025
• Study Start: June 15, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share