BPH
Conditions
Keywords
tamsulosin, tadalafil, BPH, Randomised trial, longterm, discontinuation rate
Brief summary
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).
Interventions
DRUGTamsulosin
long term follow up
DRUGTadalafil
long term follow up
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| drug discontinuation rate | 12 months | drug discontinuation rate either : lack of response, adverse events or poor compliance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in urinary parameters | 12 months | 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 |
| changes in uroflowmetry | 12 months | 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 |
| changes in post voiding residual urine | 12 months | measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter. |
| changes in sexual parameters | 12 months | 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) |
Countries
Egypt
Outcome results
None listed