Back to resultsComparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study
Primary Purpose
BPH
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Tamsulosin
Tadalafil
Sponsored by
About this trial
This is an interventional treatment trial for BPH focused on measuring tamsulosin, tadalafil, BPH, Randomised trial, longterm, discontinuation rate
Eligibility Criteria
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
Sites / Locations
- Ahmed Atta Elqaffas
- Urology and Nephrology Center at Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tamsulosin
tadalafil
Arm Description
patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up
patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up
Outcomes
Primary Outcome Measures
drug discontinuation rate
drug discontinuation rate either : lack of response, adverse events or poor compliance
Secondary Outcome Measures
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
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
changes in post voiding residual urine
measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05818670
Brief Title
Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study
Official Title
Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia A Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
September 22, 2021 (Actual)
Study Completion Date
September 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH
Keywords
tamsulosin, tadalafil, BPH, Randomised trial, longterm, discontinuation rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tamsulosin
Arm Type
Active Comparator
Arm Description
patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tamsulosin with 12 months follow up
Arm Title
tadalafil
Arm Type
Active Comparator
Arm Description
patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) treated by tadalafil 5 mg with 12 months follow up
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
long term follow up
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Description
long term follow up
Primary Outcome Measure Information:
Title
drug discontinuation rate
Description
drug discontinuation rate either : lack of response, adverse events or poor compliance
Time Frame
12 months
Secondary Outcome Measure Information:
Title
changes in urinary parameters
Description
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
Time Frame
12 months
Title
changes in uroflowmetry
Description
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
Time Frame
12 months
Title
changes in post voiding residual urine
Description
measured by pelvic ultrasound after micturation to detect the amount of residual urine in milliliter.
Time Frame
12 months
Title
changes in sexual parameters
Description
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)
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed A elqaffas, master
Organizational Affiliation
Mansoura urology and nephrology center (UNC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Atta Elqaffas
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
Facility Name
Urology and Nephrology Center at Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study
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