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.: PACTR202305669258195 Date of Approval: 05/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tadalafil and the recurrence of acute urinary retention
Official scientific title Impact of the association of Tadalafil and Silodosin on the recurrence of acute urinary retention secondary to benign prostate hyperplasia:Randomized double-blind clinical trial
Brief summary describing the background and objectives of the trial A randomized controlled trial was conducted in 70 patients meeting the inclusion criteria and consenting to participate in the study. Patients were randomly assigned to the intervention group receiving Silodosin 8 mg and Tadalafil 5 mg per day, or the control group receiving Silodosin 8 mg and a placebo per day. The study groups were followed up for one month, during which urological signs and symptoms were assessed, and ultrasound parameters were measured. Statistical analysis was performed to compare the outcomes between the groups The aim of this study is to evaluate the safety and efficacy of the combination of Tadalafil and Silodosin compared to Silodosin and placebo in preventing AUR recurrence for patients experiencing an initial episode of AUR due to BPH.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ITSRAUR
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 01/06/2020
Actual trial start date 22/04/2020
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date 28/02/2022
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 53
Recruitment status Completed
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 from a statistics book Allocation was determined by the holder of the sequence who is situated off site 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 intervention group Silodosin 8mg and Tadalafil 5mg once per day 30 days receivingTadalafil 5mg and Silodosine 8mg once perd ay 29
Control Group control group Silodosin 8mg and a placebo once per day. 30 days Received Silodosin 8mg and a placebo per day. 24 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study enrolled consenting male patients Aged more than 45 years Presenting acute urinary retention (AUR) (first episode) secondary to benign prostatic hyperplasia (BPH) Not presenting personal history of AUR, prostate cancer, prostatectomy, tumorous duct obstruction, lower urinary tract infection, lower urinary tract surgery, AUR after surgery With no simultaneous use of drugs having interactions with Tadalafil or Silodosine Patients who did not complete the follow-up Patients in whom a significant prostatic protrusion index was discovered during the study Patients in whom a bladder lithiasis, or bladder diverticulum were discovered 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
Yes 21/04/2020 The Ethics Committee of the Faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse 4002 Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the safety and efficacy of the combination of Tadalafil and Silodosin compared to Silodosin and placebo in preventing AUR recurrence for patients experiencing an initial episode of acute urinary retention due to benign prostate hyperplasia Day 2 and Day 30 of the intervention
Secondary Outcome To evaluate the impact on the lower urinary symptom and the sexuality and the quality of life Day 2 and Day 30 of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Urology Department Sahloul Hospital Sahloul Hospital Route Ceinture Sahloul 4054 Sousse Tunisia Sousse 4054 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Loghmari Ahmed 219 Rue Saleh hafsa Sousse Tunisia Sousse 4070 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Loghmari Ahmed 219 Salah Hafssa street 4070 Soussa Tunisia sousse 4070 Tunisia Self-funded
COLLABORATORS
Name Street address City Postal code Country
Bouassida Khaireddine Kssibet Soussa 4041 sousse 4041 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Loghmari loghmariahmed@gmail.com 0021698257291 219 Saleh hafsa street 4070
City Postal code Country Position/Affiliation
sousse 4070 Tunisia university hospital assistant Urology department
Role Name Email Phone Street address
Scientific Enquiries khaireddine Bouassida bouassidakhaireddine@gmail.com 0021697403480 Sahloul Hospital
City Postal code Country Position/Affiliation
sousse 4054 Tunisia Urology Professor
Role Name Email Phone Street address
Public Enquiries Asma Zorgati Zorgatiasma@gmail.com 0021650583069 Sahloul Hospital Emergency departmrnt
City Postal code Country Position/Affiliation
Sousse 4056 Tunisia Professeur Emergency Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in sickle cell anemia. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact loghmariahmed@gmail.com
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