Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40+
SponsorMarmara University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Anejaculation
Group B: Non-Anejaculation

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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