An observational study in Benign Prostate Obstruction (BPO), Lower Urinary Tract Symptom and Ejaculatory Dysfunction, sponsored by Marmara University. Not yet recruiting. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Marmara University · Observational
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.
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.
406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 100 is below the median of 179 across 132 observational studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.
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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.
Exclusion Criteria:
Male patients who develop anejaculation after initiating silodosin treatment for benign prostatic obstruction (BPO).
Male patients who do not develop anejaculation during silodosin treatment for benign prostatic obstruction (BPO).
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.
Time frame: 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.
Time frame: Baseline and 1 Month
Change in Erectile Function (IIEF-5 Score)
Erectile function will be assessed using the IIEF-5 questionnaire at baseline and at 1 month. Changes will be compared between groups.
Time frame: Baseline and 1 Month
Change in Post-Void Residual Urine Volume (PVR)
PVR volume will be measured by ultrasonography at baseline and at 1 month. Changes will be analyzed between patients with and without anejaculation.
Time frame: Baseline and 1 Month
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared publicly due to privacy concerns and institutional data protection policies. However, access to anonymized data may be considered upon reasonable scientific request, subject to ethical approval and data sharing agreements.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Ejaculatory Dysfunction
Marmara University