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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT05818670

Collaborator

(none)

160

Enrollment

Locations

Arms

22.2

Actual Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
BPH	Drug: Tamsulosin Drug: Tadalafil	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled TrialRandomized Controlled Trial

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 11, 2020

Actual Primary Completion Date :

Sep 22, 2021

Actual Study Completion Date :

Sep 17, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

drug discontinuation rate [12 months]
drug discontinuation rate either : lack of response, adverse events or poor compliance

Secondary Outcome Measures

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
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 post voiding residual urine [12 months]
measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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