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

BPH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818670
• Other study ID #: tadalafil vs tamsulosin in bph
• Status: Completed
• Phase: Phase 4
• Start date: November 11, 2020
• Est. completion date: September 17, 2022

Study information

• Verified date: March 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 17, 2022
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BPH
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Tamsulosin
long term follow up
• Tadalafil
long term follow up

Locations

Country	Name	City	State
Egypt	Ahmed Atta Elqaffas	Mansoura	Dakahlia
Egypt	Urology and Nephrology Center at Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drug discontinuation rate	drug discontinuation rate either : lack of response, adverse events or poor compliance	12 months
Secondary	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
Secondary	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
Secondary	changes in post voiding residual urine	measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter.	12 months
Secondary	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