SafetyNCT07722884
Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH
A study testing Tamsulosin 0.4 mg + Tadalafil 2.5 mg, Tamsulosin 0.4 mg + Tadalafil 5 mg and Tamsulosin 0.4 mg in people with Safety and Efficacy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Safety, Efficacy, Tamsulosin
- What is being tested?
- Tamsulosin 0.4 mg + Tadalafil 2.5 mg, Tamsulosin 0.4 mg + Tadalafil 5 mg and Tamsulosin 0.4 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 45 years of age.
- Clinical diagnosis of benign prostatic hyperplasia (BPH) and moderate to severe lower urinary tract symptoms (LUTS) [International Prostate Symptom Score (IPSS) ≥ 13].
- Maximum flow rate (Qmax) ≤ 15 mL/s, prostate volume ≥ 30 mL by transrectal ultrasound.
Who cannot join
- Patients taking α-blockers, beta-blockers, 5-alpha reductase inhibitors, phosphodiesterase-5 (PDE5) inhibitors, anticholinergics, or nitrates were excluded.
- Patients with a history of prostate or bladder surgery, lower urinary tract procedures, prostate or bladder cancer, neurological conditions affecting bladder function, severe cardiovascular disease, hepatic impairment, diabetes mellitus with complications, kidney dysfunction (acute or chronic), neurogenic bladder, or congenital urinary anomalies.
- Additionally, patients with recent myocardial infarction, unstable angina, severe heart failure, uncontrolled hypertension, Prostate-Specific Antigen (PSA)>4 ng/mL (unless cancer ruled out), active urinary tract infection, urinary retention, and those unavailable for follow-up were also excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Cairo Governorate, 11591
Salah N Salem, MBBCH, 00201066047555, salahsalem@med.asu.edu.eg
About this study
Official title: Safety and Efficacy of Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH
This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.
Read the detailed description
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are a fundamental component of modern urology, affecting extensively aging men and significantly impacting their quality of life.
Tamsulosin monotherapy, is effective in the management of BPH by acting as an α₁-adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, thereby improving urinary flow and reducing LUTS.
The combination of tamsulosin 0.4 mg with tadalafil is commonly used as an effective option. It balances sufficient symptom relief with moderate side effect profile.
- Conditions
- Safety, Efficacy, Tamsulosin, Monotherapy, Tadalafil, Lower Urinary Tract Symptoms
- Being tested
- Tamsulosin 0.4 mg + Tadalafil 2.5 mg, Tamsulosin 0.4 mg + Tadalafil 5 mg, Tamsulosin 0.4 mg
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin 0.4 mg + Tadalafil 2.5 mgDrug
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
Tamsulosin 0.4 mg + Tadalafil 5 mgDrug
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
Tamsulosin 0.4 mgDrug
Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily Receives: Drug: Tamsulosin 0.4 mg + Tadalafil 2.5 mg |
| Group B | Experimental | Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily Receives: Drug: Tamsulosin 0.4 mg + Tadalafil 5 mg |
| Group C | Experimental | Patients will receive Tamsulosin 0.4 mg once daily (monotherapy) Receives: Drug: Tamsulosin 0.4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in International Prostate Symptom Score (IPSS) score
The International Prostate Symptom Score (IPSS) is an 8-question survey used to evaluate and track the severity of lower urinary tract symptoms, often linked to an enlarged prostate (BPH).
Scores range from 0 to 35 based on symptom frequency, with a higher number indicating greater severity.
The score evaluates symptoms into the following categories:
0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Measured: 12 weeks post-procedure
Secondary outcomes (1)
Incidence of adverse events
Incidence of adverse events related to Tamsulosin such as dizziness, orthostatic hypotension, headache, fatigue, nasal congestion, retrograde ejaculation, and gastrointestinal disturbances will be recorded.
Measured: 12 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Salem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722884
- Sponsor's protocol ID
- FMASU MS 500/2026
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH
- ClinicalTrials.gov ID
- NCT07722884
- Acronym / sponsor ID
- FMASU MS 500/2026
- Conditions
- Safety, Efficacy, Tamsulosin, Monotherapy, Tadalafil, Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Jul 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.
This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.
Detailed description
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are a fundamental component of modern urology, affecting extensively aging men and significantly impacting their quality of life.
Tamsulosin monotherapy, is effective in the management of BPH by acting as an α₁-adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, thereby improving urinary flow and reducing LUTS.
The combination of tamsulosin 0.4 mg with tadalafil is commonly used as an effective option. It balances sufficient symptom relief with moderate side effect profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Tamsulosin 0.4 mg + Tadalafil 2.5 mgPatients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily |
| Group B | Experimental | Drug: Tamsulosin 0.4 mg + Tadalafil 5 mgPatients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily |
| Group C | Experimental | Drug: Tamsulosin 0.4 mgPatients will receive Tamsulosin 0.4 mg once daily (monotherapy) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 45 years of age.
- Clinical diagnosis of benign prostatic hyperplasia (BPH) and moderate to severe lower urinary tract symptoms (LUTS) [International Prostate Symptom Score (IPSS) ≥ 13].
- Maximum flow rate (Qmax) ≤ 15 mL/s, prostate volume ≥ 30 mL by transrectal ultrasound.
Key exclusion criteria (3 listed)
- Patients taking α-blockers, beta-blockers, 5-alpha reductase inhibitors, phosphodiesterase-5 (PDE5) inhibitors, anticholinergics, or nitrates were excluded.
- Patients with a history of prostate or bladder surgery, lower urinary tract procedures, prostate or bladder cancer, neurological conditions affecting bladder function, severe cardiovascular disease, hepatic impairment, diabetes mellitus with complications, kidney dysfunction (acute or chronic), neurogenic bladder, or congenital urinary anomalies.
- Additionally, patients with recent myocardial infarction, unstable angina, severe heart failure, uncontrolled hypertension, Prostate-Specific Antigen (PSA)>4 ng/mL (unless cancer ruled out), active urinary tract infection, urinary retention, and those unavailable for follow-up were also excluded from the study.
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 |
|---|---|---|
| Tamsulosin 0.4 mg + Tadalafil 2.5 mgPatients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily | Drug | Group A |
| Tamsulosin 0.4 mg + Tadalafil 5 mgPatients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily | Drug | Group B |
| Tamsulosin 0.4 mgPatients will receive Tamsulosin 0.4 mg once daily (monotherapy) | Drug | Group C |
Primary outcome
Mean change in International Prostate Symptom Score (IPSS) score
Time frame: 12 weeks post-procedure
The International Prostate Symptom Score (IPSS) is an 8-question survey used to evaluate and track the severity of lower urinary tract symptoms, often linked to an enlarged prostate (BPH). Scores range from 0 to 35 based on symptom frequency, with a higher number indicating greater severity. The score evaluates symptoms into the following categories: 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
1 secondary outcome
Incidence of adverse events
Time frame: 12 weeks post-procedure
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 23 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamsulosin 0.4 mg + Tadalafil 2.5 mg, Tamsulosin 0.4 mg + Tadalafil 5 mg and Tamsulosin 0.4 mg in people with Safety and Efficacy, run by Ain Shams 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 3 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: looking for participants now, as of the sponsor's last update on 23 Jul 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. 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 Salah N Salem, MBBCH (00201066047555, salahsalem@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in International Prostate Symptom Score (IPSS) score (time frame: 12 weeks post-procedure). 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 23 Jul 2026.