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

M

Mansoura University

Status and phase

Completed
Phase 4

Conditions

BPH

Treatments

Drug: Tadalafil
Drug: Tamsulosin

Study type

Interventional

Funder types

Other

Identifiers

NCT05818670
tadalafil vs tamsulosin in bph

Details and patient eligibility

About

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

Full 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).

Enrollment

160 patients

Sex

Male

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups

tamsulosin
Active Comparator group
Description:
patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up
Treatment:
Drug: Tamsulosin
tadalafil
Active Comparator group
Description:
patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up
Treatment:
Drug: Tadalafil

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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