Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin
NCT ID: NCT06989515
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-06-15
2026-06-12
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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Inclusion Criteria
* 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
* 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
40 Years
MALE
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Tarik Emre Sener
Assoc. Prof.
Central Contacts
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Other Identifiers
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MAR.UAD.0023
Identifier Type: -
Identifier Source: org_study_id
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