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Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamsulosin | Active Comparator | patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up |
|
| tadalafil | Active Comparator | patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | long term follow up |
| |
| Tadalafil |
| Measure | Description | Time Frame |
|---|---|---|
| drug discontinuation rate | drug discontinuation rate either : lack of response, adverse events or poor compliance | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ahmed A elqaffas, master | Mansoura urology and nephrology center (UNC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Atta Elqaffas | Al Mansurah | Dakahlia Governorate | 35511 | Egypt | ||
| Urology and Nephrology Center at Mansoura University |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Randomized Controlled Trial
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| Drug |
long term follow up |
|
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 |
| Al Mansurah |
| Dakahlia Governorate |
| 35511 |
| Egypt |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |