Enlarged Prostate With Lower Urinary Tract SymptomsPhase 3NCT06491108
Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
A Phase 3 study testing Vardenafil 5 Mg Oral Tablet in people with Enlarged Prostate With Lower Urinary Tract Symptoms, run by Tanta University at 1 site in Egypt.
Trial summary
The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Enlarged Prostate With Lower Urinary Tract Symptoms
- What is being tested?
- Vardenafil 5 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sexually active patients .
- ModerateBPH related LUTS ( bengin prostatic hyperplasia related lower urinary tract symtoms ) i.e: (international prostatic symptom score 8 to 19 : the higher score is the worse symptoms ).
- Patients accepted medical treatment and completed 12 weeks on medical treatment and strict follow up .
Who cannot join
- Indication for combined therapy as prostate size over 40 gm .
- Gross hematuria.
- Refractory urine retention .
- Bilateral hydro-ureteronephrosis or renal insufficiency secondary to bengin prostatic hyperplasia.
- Bladder diverticula or calculi .
- History of bladder or prostate cancer.
- Unwilling patients to medical therapy.
- History of pelvic surgery or urethral stricture.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculity of medicine - Tanta university
Tanta, Gharbia Governorate, 31528
Mohamed G. Soliman, MD, 01018362537, mohamed.soliman@med.tanta.edu.eg
Ahmed R. Abouramadan, MD, 01001424064, ahmed.abouramadan@med.tanta.edu.eg
About this study
Official title: Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.
The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS.
Read the detailed description
This is prospective randomized controlled study that will be conducted on men with BPH related LUTS amenable to medical treatment at Urology Department, Faculty of Medicine, Tanta University - Egypt after having their written informed consent.
The study is planned to include 150 patients in the study period from April 2024 to April 2025. Each enrolled patient must complete 12 weeks on medication with strict scheduled follow up.
Inclusion criteria:
Sexually active patients with moderate BPH related LUTS amenable to medical treatment and completed 12 weeks follow up period.
Exclusion criteria:
Indication for combined therapy in patients who have moderate to severe LUTS and an increased risk of disease progression (e.g. prostate volume more than 40 ml) or patients in need for anti-muscarinic for predominant storage symptoms.
Indication for surgical intervention:
Medically complicated patients:
Cardiac patients, unstable angina, recent myocardial infarction (<3months), hypotension.
Concomitant uses (potassium channel openers, alpha 1 blockers, nitrates). Stroke since less than 6 months.
- Being tested
- Vardenafil 5 Mg Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vardenafil 5 Mg Oral TabletDrug
Also called Vardenafil 5 mg
Comparing safety and efficacy of Vardenafil 5 mg twice oral daily versus established drugs e.g.Tadalafil 5mg and Tamsulosin 0.4 mg once oral daily in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS (benign prostatic hyperplasia related lower urinary tract syptoms )
| Study group | Role | What they receive |
|---|---|---|
| Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Experimental | 50 patients will take Vardenafil 5 mg tabs twice daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects Receives: Drug: Vardenafil 5 Mg Oral Tablet |
| Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Active comparator | 50 patients will take Tadalafil 5 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects Receives: Drug: Vardenafil 5 Mg Oral Tablet |
| Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Active comparator | 50 patients will take Tamsulosin 0.4 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects Receives: Drug: Vardenafil 5 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
International prostate symptom score (IPSS total score)
Change in pre and post treatment condition (IPSS : international prostate symptom score - decresing in the score equals improving the symptoms )
Measured: 3 months
The maximum urinary flow rate (Q-max)
Change in pre and post treatment condition (increasing at Q-max equals improving the symptoms )
Measured: 3 months
Secondary outcomes (1)
Sexual Health Inventory for Men (SHIM)
Change in pre and post treatment condition (SHIM: Sexual Health Inventory for Men - increasing in the score equals improving the symptoms )
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 posted8 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enlarged Prostate With Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Tanta 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Bashir Ali Mohamed Baz, Tanta University
- Investigators
- Hazem B. Baz, M.B.B.Ch, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491108
- Sponsor's protocol ID
- Vardenafil for BPH / LUTS
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagasubramanian S, John NT, Antonisamy B, Mukha RP, Jeyachandra Berry CS, Kumar S, Devasia A, Kekre NS. Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double-blinded, randomised controlled trial. BJU Int. 2020 May;125(5):718-724. doi: 10.1111/bju.15027. Epub 2020 Feb 27.
PubMed 32012409Stief CG, Porst H, Neuser D, Beneke M, Ulbrich E. A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol. 2008 Jun;53(6):1236-44. doi: 10.1016/j.eururo.2008.01.075. Epub 2008 Feb 4.
PubMed 18281145
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT06491108
- Acronym / sponsor ID
- Vardenafil for BPH / LUTS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Jul 2024 (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.
The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS.
Detailed description
This is prospective randomized controlled study that will be conducted on men with BPH related LUTS amenable to medical treatment at Urology Department, Faculty of Medicine, Tanta University - Egypt after having their written informed consent.
The study is planned to include 150 patients in the study period from April 2024 to April 2025. Each enrolled patient must complete 12 weeks on medication with strict scheduled follow up.
Inclusion criteria:
Sexually active patients with moderate BPH related LUTS amenable to medical treatment and completed 12 weeks follow up period.
Exclusion criteria:
Indication for combined therapy in patients who have moderate to severe LUTS and an increased risk of disease progression (e.g. prostate volume more than 40 ml) or patients in need for anti-muscarinic for predominant storage symptoms.
Indication for surgical intervention:
Medically complicated patients:
Cardiac patients, unstable angina, recent myocardial infarction (<3months), hypotension.
Concomitant uses (potassium channel openers, alpha 1 blockers, nitrates). Stroke since less than 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Experimental | Drug: Vardenafil 5 Mg Oral Tablet50 patients will take Vardenafil 5 mg tabs twice daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects |
| Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Active comparator | Drug: Vardenafil 5 Mg Oral Tablet50 patients will take Tadalafil 5 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects |
| Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Active comparator | Drug: Vardenafil 5 Mg Oral Tablet50 patients will take Tamsulosin 0.4 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sexually active patients .
- ModerateBPH related LUTS ( bengin prostatic hyperplasia related lower urinary tract symtoms ) i.e: (international prostatic symptom score 8 to 19 : the higher score is the worse symptoms ).
- Patients accepted medical treatment and completed 12 weeks on medical treatment and strict follow up .
Key exclusion criteria (8 listed)
- Indication for combined therapy as prostate size over 40 gm .
- Gross hematuria.
- Refractory urine retention .
- Bilateral hydro-ureteronephrosis or renal insufficiency secondary to bengin prostatic hyperplasia.
- Bladder diverticula or calculi .
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 |
|---|---|---|
| Vardenafil 5 Mg Oral TabletAlso: Vardenafil 5 mgComparing safety and efficacy of Vardenafil 5 mg twice oral daily versus established drugs e.g.Tadalafil 5mg and Tamsulosin 0.4 mg once oral daily in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS (benign prostatic hyperplasia related lower urinary tract syptoms ) | Drug | Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia, Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia, Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia |
Primary outcome
International prostate symptom score (IPSS total score)
Time frame: 3 months
Change in pre and post treatment condition (IPSS : international prostate symptom score - decresing in the score equals improving the symptoms )
The maximum urinary flow rate (Q-max)
Time frame: 3 months
Change in pre and post treatment condition (increasing at Q-max equals improving the symptoms )
1 secondary outcome
Sexual Health Inventory for Men (SHIM)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 32012409Nagasubramanian S, John NT, Antonisamy B, Mukha RP, Jeyachandra Berry CS, Kumar S, Devasia A, Kekre NS. Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double-blinded, randomised controlled trial. BJU Int. 2020 May;125(5):718-724. doi: 10.1111/bju.15027. Epub 2020 Feb 27.
- Results publication: PubMed 18281145Stief CG, Porst H, Neuser D, Beneke M, Ulbrich E. A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol. 2008 Jun;53(6):1236-44. doi: 10.1016/j.eururo.2008.01.075. Epub 2008 Feb 4.
- Individual participant dataSharing planned: No
Related trials for Enlarged Prostate With Lower Urinary Tract Symptoms
Enrolling by invitation
Emsella for Reducing tSUI After HOLEP
Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
Not yet recruitingPhase 4
Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.
Benign Prostatic Hyperplasia (BPH), Obstructive Lower Urinary Tract Symptoms (LUTS)
RecruitingObservational study
Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry
BPH (Benign Prostatic Hyperplasia)
Recruiting
Ejaculatory-Sparing HoLEP vs Standard HoLEP
Enlarged Prostate (BPH), Enlarged Prostate With Lower Urinary Tract Symptoms
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.
Hazem B. Baz, M.B.B.Ch principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vardenafil 5 Mg Oral Tablet in people with Enlarged Prostate With Lower Urinary Tract Symptoms, run by Tanta 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 8 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hazem B. Baz, M.B.B.Ch (00201020337967, hazem30839637@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International prostate symptom score (IPSS total score) (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT06491108, which also lists 2 linked publications.
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 8 Jul 2024.