Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study

Study Overview
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Brief Summary
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Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial

Detailed Description
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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).

Official Title
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Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia A Randomised Trial

Conditions
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BPH

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Tadalafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tamsulosin<br>patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up | Drug: Tamsulosin<br>* long term follow up<br>|
| Active Comparator: tadalafil<br>patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up | Drug: Tadalafil<br>* long term follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug discontinuation rate | drug discontinuation rate either : lack of response, adverse events or poor compliance | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 months | 
| changes in post voiding residual urine | measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter. | 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) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tamsulosin, tadalafil, BPH, Randomised trial, longterm, discontinuation rate