Benign Prostate Obstruction (BPO)NCT06989515
Clinical Outcomes and Ejaculatory Function in BPO Patients Treated With Silodosin
An observational study of Benign Prostate Obstruction (BPO) and Lower Urinary Tract Symptom, run by Marmara University.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostate Obstruction (BPO), Lower Urinary Tract Symptom, Ejaculatory Dysfunction
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 12 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Does Anejaculation Reflect Better Clinical Outcomes in BPO Patients Receiving Silodosin?
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.
Read the detailed description
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.
- Conditions
- Benign Prostate Obstruction (BPO), Lower Urinary Tract Symptom, Ejaculatory Dysfunction, Anejaculation, Silodosin
- Keywords
- Silodosin, Ejaculatory Dysfunction, Benign Prostatic Obstruction, Lower Urinary Tract Symptoms, Alpha-blocker Side Effects
- Medical subject headings
- Lower Urinary Tract Symptoms, Ejaculatory Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anejaculation | Male patients who develop anejaculation after initiating silodosin treatment for benign prostatic obstruction (BPO). | |
| Non-Anejaculation | Male patients who do not develop anejaculation during silodosin treatment for benign prostatic obstruction (BPO). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 1 Month
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Obstruction (BPO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989515
- Sponsor's protocol ID
- MAR.UAD.0023
- Status last verified
- Jun 2025
- First submitted
- 9 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Anejaculation Reflect Better Clinical Outcomes in BPO Patients Receiving Silodosin?
- ClinicalTrials.gov ID
- NCT06989515
- Acronym / sponsor ID
- MAR.UAD.0023
- Conditions
- Benign Prostate Obstruction (BPO), Lower Urinary Tract Symptom, Ejaculatory Dysfunction, Anejaculation, Silodosin
- Keywords
- Silodosin, Ejaculatory Dysfunction, Benign Prostatic Obstruction, Lower Urinary Tract Symptoms, Alpha-blocker Side Effects
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anejaculation | – | –Male patients who develop anejaculation after initiating silodosin treatment for benign prostatic obstruction (BPO). |
| Non-Anejaculation | – | –Male patients who do not develop anejaculation during silodosin treatment for benign prostatic obstruction (BPO). |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline and 1 Month
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)
Time frame: Baseline and 1 Month
Qmax will be measured via uroflowmetry at baseline and 1 month. Changes will be compared between the two groups.
2 secondary outcomes
Change in Erectile Function (IIEF-5 Score)
Time frame: Baseline and 1 Month
Change in Post-Void Residual Urine Volume (PVR)
Time frame: Baseline and 1 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: 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.
Related trials for Benign Prostate Obstruction (BPO)
RecruitingObservational study
SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate
Benign Prostate Obstruction (BPO)
RecruitingObservational study
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
Urinary Retention, Benign Prostate Obstruction (BPO)
Not yet recruitingObservational study
Selective Median Lobe Surgery Outcomes Study
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:
Benign Prostate Enlargement, Benign Prostate Hypertrophy(BPH)
Not yet recruitingObservational study
Enucleation Ratio as a Novel Predictor of Symptomatic Improvement After HoLEP
Benign Prostate Obstruction (BPO)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostate Obstruction (BPO) and Lower Urinary Tract Symptom, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact günal özgür, Urology Specialist (+905357849485, gunalozgur91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Baseline and 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.