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

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

Study Overview

• Status: Completed
• Conditions: BPH
• Intervention / Treatment: Drug: Tamsulosin; Drug: Tadalafil

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Ahmed Atta Elqaffas
    • Mansoura, Dakahlia, Egypt, 35511
      • Urology and Nephrology Center at Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tamsulosin; patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up	Drug: Tamsulosin; long term follow up
Active Comparator: tadalafil; patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up	Drug: Tadalafil; long term follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
drug discontinuation rate	drug discontinuation rate either : lack of response, adverse events or poor compliance	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 months
changes in post voiding residual urine	measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter.	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)	12 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: ahmed A elqaffas, master, Mansoura urology and nephrology center (UNC)

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 17, 2022

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: BPH; tamsulosin; Randomised trial; tadalafil; discontinuation rate; longterm
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tadalafil; Tamsulosin
• Other Study ID Numbers: tadalafil vs tamsulosin in bph

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No