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

Phase 4

Completed

• Conditions: BPH
• Interventions: Drug: Tamsulosin; Drug: Tadalafil

• Registration Number: NCT05818670
• Lead Sponsor: Mansoura University

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).

Study Timeline

• Study Start: 2020-11-11
• Primary Completion: 2021-09-22
• Study Completion: 2022-09-17
• Status Verified: 2023-03
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Study First Posted: 2023-04-19
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tamsulosin	Tamsulosin	patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up
tadalafil	Tadalafil	patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up

Primary Outcome Measures

Name	Time	Method
drug discontinuation rate	12 months	drug discontinuation rate either : lack of response, adverse events or poor compliance

Secondary Outcome Measures

Name	Time	Method
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 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 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)
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

Trial Locations

Locations (2)

Ahmed Atta Elqaffas; 🇪🇬 Mansoura, Dakahlia, Egypt

Urology and Nephrology Center at Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt