About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
Locations
Sponsors and contacts
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