Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491108
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-29
Brief Title:
Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia A Prospective Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of voiding function sexual function and quality of life in the management of moderate BPH related LUTS
Detailed Description:
This is prospective randomized controlled study that will be conducted on men with BPH related LUTS amenable to medical treatment at Urology Department Faculty of Medicine Tanta University - Egypt after having their written informed consent
The study is planned to include 150 patients in the study period from April 2024 to April 2025 Each enrolled patient must complete 12 weeks on medication with strict scheduled follow up
Inclusion criteria
Sexually active patients with moderate BPH related LUTS amenable to medical treatment and completed 12 weeks follow up period
Exclusion criteria
Indication for combined therapy in patients who have moderate to severe LUTS and an increased risk of disease progression eg prostate volume more than 40 ml or patients in need for anti-muscarinic for predominant storage symptoms
Indication for surgical intervention
Medically complicated patients
Cardiac patients unstable angina recent myocardial infarction 3months hypotension
Concomitant uses potassium channel openers alpha 1 blockers nitrates Stroke since less than 6 months
The study is planned to include 150 patients in the study period from April 2024 to April 2025 Each enrolled patient must complete 12 weeks on medication with strict scheduled follow up
Inclusion criteria
Sexually active patients with moderate BPH related LUTS amenable to medical treatment and completed 12 weeks follow up period
Exclusion criteria
Indication for combined therapy in patients who have moderate to severe LUTS and an increased risk of disease progression eg prostate volume more than 40 ml or patients in need for anti-muscarinic for predominant storage symptoms
Indication for surgical intervention
Medically complicated patients
Cardiac patients unstable angina recent myocardial infarction 3months hypotension
Concomitant uses potassium channel openers alpha 1 blockers nitrates Stroke since less than 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None