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

Mansoura University160 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

BPH

Interventions

TamsulosinDRUG

long term follow up

TadalafilDRUG

long term follow up

Eligibility

Sex: MALEMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Ahmed Atta Elqaffas

Al Mansurah, Dakahlia Governorate, Egypt

Urology and Nephrology Center at Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

drug discontinuation rate

drug discontinuation rate either : lack of response, adverse events or poor compliance

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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

Time frame: 12 months

changes in post voiding residual urine

measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter.

Time frame: 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)

Time frame: 12 months

Data from ClinicalTrials.gov

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