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NCT Number: NCT05818670

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

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

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Key information

Conditions

BPH

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Atta Elqaffas, Al Mansurah, Dakahlia Governorate, Egypt

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

long term follow up

Tadalafil

Drug

long term follow up

Primary outcomes

  1. drug discontinuation rate

    Time frame: 12 months

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

Secondary outcomes

  1. changes in urinary parameters

    Time frame: 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

  2. changes in uroflowmetry

    Time frame: 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

  3. changes in post voiding residual urine

    Time frame: 12 months

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

  4. changes in sexual parameters

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia A Randomised Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 19, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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