BPH (Benign Prostatic Hyperplasia)Phase 4NCT07815379
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
A Phase 4 study testing alpha blocker monotherapy Tamsulosin and alpha blockers Tamsulosin and Silodosin in people with BPH (Benign Prostatic Hyperplasia), run by Mansoura University at 1 site in Egypt.
Trial summary
Failed medical treatment to alleviate LUTS and AUR is an indication for intervention, some trials were published elucidating the possible use of standard dose tamsulosin and silodosin and double dose tamsulosin but to the best of our knowledge, no studies with head-to-head comparison between Tamsulosin and Combination… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- alpha blocker monotherapy Tamsulosin and alpha blockers Tamsulosin and Silodosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2025to Nov 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Age ≥40 years. Catheterized patients due to acute urine retention secondary to BPO. Patients with moderate and severe LUTS secondary to BPH as proven by IPSS (International Prostate Symptoms score) ≥8 and Qmax <15 ml/sec with total void urine volume >125 cc.
Who cannot join
- Patients with neurological problems as: uncontrolled DM, parkinsonism and cerebral stroke.
- Patients with history of previous prostate surgery. Patients with complicated BPH necessitating intervention as: recurrent/persistent UTI, recurrent hematuria, bladder stones and indwelling urethral catheter due to chromic urine retention (CUR).
- Patients with suspected malignancy by abnormal Digital Rectal Examination (DRE) and or high PSA.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and Nephrology Center, Mnasoura University
Al Mansurah, Dakahlia Governorate, 35561
About this study
Official title: Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction: A Randomized Clinical Trial
Failed medical treatment to alleviate LUTS and AUR is an indication for intervention, some trials were published elucidating the possible use of standard dose tamsulosin and silodosin and double dose tamsulosin but to the best of our knowledge, no studies with head-to-head comparison between Tamsulosin and Combination of Tamsulosin and Silodosin for Management of Lower Urinary Tract Symptoms and Acute Urine Retention in Patients with Benign Prostatic Hyperplasia.
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- alpha blocker monotherapy Tamsulosin, alpha blockers Tamsulosin and Silodosin
- Keywords
- BPH, alpha blockers, LUTS
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha blocker monotherapy TamsulosinDrug
Effect of Tamsulosin and placebo in Management of Lower Urinary Tract Symptoms and Acute Urine Retention in Patients with Benign Prostatic Hyperplasia.
alpha blockers Tamsulosin and SilodosinDrug
BPH patients are given dual alpha blockers compared to single alpha blocker drug
| Study group | Role | What they receive |
|---|---|---|
| Single alpha blocker for BPH treatment | Placebo comparator | BPH patients in this arm are given single alpha blocker drug with placebo Receives: Drug: alpha blocker monotherapy Tamsulosin |
| Double alpha blockers for BPH management | Active comparator | BPH patients in this arm are given double alpha blocker drugs Receives: Drug: alpha blockers Tamsulosin and Silodosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS change
IPSS score change at 1 and 3 months following drug adminstration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start12 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPH (Benign Prostatic Hyperplasia)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abolazm, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815379
- Sponsor's protocol ID
- MD.25.09.1037
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osman T, Elawady H, Fawaz K, Shabayek M, Essam MD, Osman D, ElSaeed KO. Evaluation of Tamsulosin 0.4 mg versus 0.8 mg in management of lower urinary tract symptoms due to benign prostatic enlargement. Int Urol Nephrol. 2024 Jun;56(6):1811-1816. doi: 10.1007/s11255-023-03912-7. Epub 2024 Jan 14.
PubMed 38219259
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07815379
- Acronym / sponsor ID
- MD.25.09.1037
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Keywords
- BPH, alpha blockers, LUTS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Sep 2026 (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.
Failed medical treatment to alleviate LUTS and AUR is an indication for intervention, some trials were published elucidating the possible use of standard dose tamsulosin and silodosin and double dose tamsulosin but to the best of our knowledge, no studies with head-to-head comparison between Tamsulosin and Combination of Tamsulosin and Silodosin for Management of Lower Urinary Tract Symptoms and Acute Urine Retention in Patients with Benign Prostatic Hyperplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single alpha blocker for BPH treatment | Placebo comparator | Drug: alpha blocker monotherapy TamsulosinBPH patients in this arm are given single alpha blocker drug with placebo |
| Double alpha blockers for BPH management | Active comparator | Drug: alpha blockers Tamsulosin and SilodosinBPH patients in this arm are given double alpha blocker drugs |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥40 years. Catheterized patients due to acute urine retention secondary to BPO. Patients with moderate and severe LUTS secondary to BPH as proven by IPSS (International Prostate Symptoms score) ≥8 and Qmax <15 ml/sec with total void urine volume >125 cc.
Key exclusion criteria (3 listed)
- Patients with neurological problems as: uncontrolled DM, parkinsonism and cerebral stroke.
- Patients with history of previous prostate surgery. Patients with complicated BPH necessitating intervention as: recurrent/persistent UTI, recurrent hematuria, bladder stones and indwelling urethral catheter due to chromic urine retention (CUR).
- Patients with suspected malignancy by abnormal Digital Rectal Examination (DRE) and or high PSA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alpha blocker monotherapy TamsulosinEffect of Tamsulosin and placebo in Management of Lower Urinary Tract Symptoms and Acute Urine Retention in Patients with Benign Prostatic Hyperplasia. | Drug | Single alpha blocker for BPH treatment |
| alpha blockers Tamsulosin and SilodosinBPH patients are given dual alpha blockers compared to single alpha blocker drug | Drug | Double alpha blockers for BPH management |
Primary outcome
IPSS change
Time frame: 3 months
IPSS score change at 1 and 3 months following drug adminstration
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 11 Sep 2026.
- Background: PubMed 38219259Osman T, Elawady H, Fawaz K, Shabayek M, Essam MD, Osman D, ElSaeed KO. Evaluation of Tamsulosin 0.4 mg versus 0.8 mg in management of lower urinary tract symptoms due to benign prostatic enlargement. Int Urol Nephrol. 2024 Jun;56(6):1811-1816. doi: 10.1007/s11255-023-03912-7. Epub 2024 Jan 14.
- RCT about similar topicLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alpha blocker monotherapy Tamsulosin and alpha blockers Tamsulosin and Silodosin in people with BPH (Benign Prostatic Hyperplasia), run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSS change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07815379, which also lists 1 linked publication.
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 11 Sep 2026.