Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311592558473 Date of Approval: 29/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title To compare the efficacy and impact on sexual function of combination of Tadalafil and Tamsulosin versus Tamsulosin alone in the management of Benign prostatic hyperplasia in patients attending Lagos State University Teaching Hospital
Official scientific title Outcome measures of Tadalafil-Tamsulosin combination therapy versus Tamsulosin alone in the management of benign prostate hyperplasia in patients attending Lagos State University Teaching Hospital.
Brief summary describing the background and objectives of the trial Background: Benign Prostatic Hyperplasia (BPH) is a common condition affecting men over the age of 50. It is characterized by an enlargement of the prostate gland, leading to lower urinary tract symptoms (LUTS) such as urinary frequency, urgency, nocturia, weak stream, and incomplete emptying. Tamsulosin is a commonly used alpha-blocker medication for the management of BPH. However, it has limitations in terms of its efficacy in some patients and its ability to improve sexual function. Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor medication that has been shown to improve LUTS and sexual function in men with BPH. The combination of Tadalafil and Tamsulosin may provide additional benefits in the management of BPH. Objective: The aim of this study is to compare patient outcome measures between Tadalafil-Tamsulosin combination therapy and Tamsulosin alone in the management of BPH. Methods: This will be a randomized controlled trial involving adult men diagnosed with BPH. Participants will be randomized into two groups: Tadalafil-Tamsulosin combination therapy group and Tamsulosin alone group. outcome measures will be the International Prostate Symptom Score (IPSS), Quality of life, erectile function, maximum urinary flow rate and post-void residual urine volume. All data will be analyzed using SPSS and p-value <0.05 will be assume as significant.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2024
Actual trial start date
Anticipated date of last follow up 31/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 182
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tadalafil Tamsulosin combination therapy Tadalafil 5 mg plus Tamsulosin 0.4 mg daily for 12 weeks Its an oral medication consisting of Tamsulosin 0.4 mg which is a Alpha adrenergic blocker while Tadalafil 5mg is a 5 Phosphodiesterase 5 inhibitor 91
Control Group Tamsulosin Alone 0.4 mg Daily for 12 weeks Its an oral medication containing alpha adrenergic blocker 91 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients must be 45 years and above with mild to moderate IPSS (0-19) Patients with PSA less than or equals 4ng/ml, normal DRE and imaging studies Patients with peak flow rate less than 15mls/sec and PVR greater than or equals 50mls Patients who give verbal and written consent to the study Patients with severe IPSS, PSA greater than 4ng/ml and peak flow rate greater than 15mls/sec. Patients with PVR less than 50mls. Contraindications to study medications. Patients with no sexual partner during the study period 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 100 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 21/11/2023 Lagos State University Teaching Hospital Health Research Ethics Committee .
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Way, Ikeja Lagos Nigeria Lagos 100271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome International prostatic symptoms score 12 weeks post first day of commencement of intervention
Secondary Outcome Quality of life, erectile function, maximum urinary flow rate and post-void residual urine volume 12 weeks post first day of commencement of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-2 Oba Akinjobi Way Ikeja Lagos Nigeria Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 1-5 Oba Akinjobi Way Ikeja Lagos Lagos 100271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Atobatele Kazeem 1-5 Oba Akinjobi Way Ikeja Lagos Lagos 100271 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kazeem Atobatele atobatelekazeem1@gmail.com 2348038435392 1-5 Oba Akinjobi Way Ikeja
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Clement Akinsola ceefourme@gmail.com 2348174226011 1-5 Oba Akijobi Way
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Data Analyst
Role Name Email Phone Street address
Scientific Enquiries Ralph Edewor akporalph12@gmail.com 2348026406842 1-5 Oba Akinjobi Way Ikeja
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Colleague
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data derived from this study will only be used for the sole purpose of this research We are committed to sharing the individual participant data that underlie the results reported in our study. Access to the data will be provided upon request, following the completion of a formal agreement ensuring the appropriate use of the data and in accordance with ethical standards. Requests for data access can be made to Atobatele Kazeem, atobatelekazeem1@gmail.com Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months from completion of the study None
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information