Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin (NCT06989515) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin
100 participantsStarted 2025-06-15
Plain-language 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.
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in International Prostate Symptom Score (IPSS)