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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-11

Study Completion Date

2022-09-17

Brief Summary

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Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial

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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).

Conditions

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BPH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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tamsulosin

patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

long term follow up

tadalafil

patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up

Group Type ACTIVE_COMPARATOR

Tadalafil

Intervention Type DRUG

long term follow up

Interventions

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Tamsulosin

long term follow up

Intervention Type DRUG

Tadalafil

long term follow up

Intervention Type DRUG

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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes