BPHPhase 4NCT05818670
Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study
A Phase 4 study testing Tamsulosin and Tadalafil in people with BPH, run by Mansoura University at 2 sites in Egypt.
Trial summary
Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- BPH
- What is being tested?
- Tamsulosin and Tadalafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesEgypt
- Study dates
- 11 Nov 2020to 17 Sep 2022
- Phase
- Phase 4
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with Lower Urinary Tract Symptoms
- married and sexually active
- age more than 50 years
- IPSS more than 12
- Q max less than 15 ml/s
- Post voiding residual less than 150 ml
Who cannot join
- prostatic adenocarcinoma
- cardiac patients on nitrates, patient with unstable angina or recent history of myocardial infarction
- vesical stones
- active Urinary Tract Infection
- patient refused participation in the study
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ahmed Atta Elqaffas
Al Mansurah, Dakahlia Governorate, 35511
Urology and Nephrology Center at Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia A Randomised Trial
Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial
Read the detailed description
Assessment of the discontinuation rate of tamsulosin and tadalafil after 12 months follow up either and evaluate the changes in urinary parameters and sexual parameters in patients with lower urinary tract symptoms due to BPH concomitant with erectile dysfunction. We tried to overcome the limitations of the previous studies by designing a prospective randomized controlled trial as the present study is the first randomized controlled trial that evaluate the safety, discontinuation rate and efficacy of tadalafil compared with tamsulosin for long term follow up (12 months).
- Conditions
- BPH
- Being tested
- Tamsulosin, Tadalafil
- Keywords
- tamsulosin, tadalafil, BPH, Randomised trial, longterm, discontinuation rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
long term follow up
TadalafilDrug
long term follow up
| Study group | Role | What they receive |
|---|---|---|
| tamsulosin | Active comparator | patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up Receives: Drug: Tamsulosin |
| tadalafil | Active comparator | patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up Receives: Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug discontinuation rate
drug discontinuation rate either : lack of response, adverse events or poor compliance
Measured: 12 months
Secondary outcomes (4)
changes in urinary parameters
detect the improvement in International Prostate Symptom Score (IPSS) . The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms
Measured: 12 months
changes in uroflowmetry
detect the changes in maximum flow rate (Q max) as Qmax below 10 ml /sec is obstructed flow curve , between 10 to 15 ml / sec is equivocal and above 15 ml/ sec is normal
Measured: 12 months
changes in post voiding residual urine
measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter.
Measured: 12 months
changes in sexual parameters
changes in International Index of Erectile Function(IIEF) . IIEF questionnaire is classified as : No erectile dysfunction (26-30points), Mild ED (score 22-25), Mild to moderate (17-21), Moderate ED (score 11-16), Severe ED (score ≤ 10)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start11 Nov 2020
- Primary completion22 Sep 2021
- Study completion17 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ahmed A elqaffas, master, Principal investigator, Mansoura urology and nephrology center (UNC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818670
- Sponsor's protocol ID
- tadalafil vs tamsulosin in bph
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia A Randomised Trial
- ClinicalTrials.gov ID
- NCT05818670
- Acronym / sponsor ID
- tadalafil vs tamsulosin in bph
- Conditions
- BPH
- Keywords
- tamsulosin, tadalafil, BPH, Randomised trial, longterm, discontinuation rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 17 Sep 2022 (actual)
- First posted
- 19 Apr 2023 (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.
Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial
Detailed description
Assessment of the discontinuation rate of tamsulosin and tadalafil after 12 months follow up either and evaluate the changes in urinary parameters and sexual parameters in patients with lower urinary tract symptoms due to BPH concomitant with erectile dysfunction. We tried to overcome the limitations of the previous studies by designing a prospective randomized controlled trial as the present study is the first randomized controlled trial that evaluate the safety, discontinuation rate and efficacy of tadalafil compared with tamsulosin for long term follow up (12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| tamsulosin | Active comparator | Drug: Tamsulosinpatients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up |
| tadalafil | Active comparator | Drug: Tadalafilpatients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with Lower Urinary Tract Symptoms
- married and sexually active
- age more than 50 years
- IPSS more than 12
- Q max less than 15 ml/s
Key exclusion criteria (5 listed)
- prostatic adenocarcinoma
- cardiac patients on nitrates, patient with unstable angina or recent history of myocardial infarction
- vesical stones
- active Urinary Tract Infection
- patient refused participation in 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 |
|---|---|---|
| Tamsulosinlong term follow up | Drug | tamsulosin |
| Tadalafillong term follow up | Drug | tadalafil |
Primary outcome
drug discontinuation rate
Time frame: 12 months
drug discontinuation rate either : lack of response, adverse events or poor compliance
4 secondary outcomes
changes in urinary parameters
Time frame: 12 months
changes in uroflowmetry
Time frame: 12 months
changes in post voiding residual urine
Time frame: 12 months
changes in sexual parameters
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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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.
ahmed A elqaffas, master principal investigator
Mansoura urology and nephrology center (UNC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin and Tadalafil in people with BPH, run by Mansoura University at 2 sites 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
drug discontinuation rate (time frame: 12 months). 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 19 Apr 2023.