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.: PACTR202206546247568 Date of Approval: 21/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title malleable penile prosthesis for treatment of erectile dysfunction
Official scientific title Malleable penile prosthesis predictors of success and patient satisfaction
Brief summary describing the background and objectives of the trial To review the malleable penile prosthesis, efficacy and Its Role in the Treatment of Erectile Dysfunction., and patient and partner satisfaction. The current approach to addressing intra- and postoperative complications and their predictors after the placement of these devices will be reviewed. all patients will be classified into two groups according to risk factors and predictors of success and complications one is the main intervention group another is the control group without any risk factor, each group will receive the same intervention.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) penile prosthesis
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2022
Actual trial start date 01/07/2022
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date 01/02/2024
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group malleable penile prosthesis implantation once 10 to 15 years All cases will receive the malleable PP, this group will have the criteria under research and the predictors of complications like diabetes neutrophil-lymphocyte ratio, etc..., The model will be selected on the basis of the stretched penile length (SPL) from the symphysis pubis to mid-glans. The largest diameter that could be comfortably inserted will be used. The patients will receive intravenous cefuroxime and gentamycin on the morning and evening of surgery, and the next day morning before discharge, followed by oral amoxicillin-clavulanate for the next 5 days. Foley catheter will be inserted in patients older than 60 years routinely and will be removed on 1st post-operative day. Sexual intercourse was permitted after 6−8 weeks after the PP implantation 25
Control Group malleable penile prosthesis implantation once 10-15 years the same malleable penile prosthesis in the intervention group will be received by the same technique but this group free of all predictors and risk factors for complications under research 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Sexually active male patients (20-70) years old. • International index of erectile function (IIEF=1-16). • Cardiac patients with contraindications for the use of PDE5Is • Patients who need high doses of PDE5Is to achieve an erection. • Advanced Peyronie’s Disease • Priapism • Following penile or pelvic trauma or surgery • Active infection anywhere in the body, particularly urinary tract or genital infection • Unresolved problems of urination such as elevated residual urine volume secondary to the neurogenic bladder or bladder outlet obstruction (BPE) • Patients not willing to go for device revision surgery Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 08/06/2022 medical research ethics committee faculty of medicine sohag university
Ethics Committee Address
Street address City Postal code Country
Sohag-Sohag University-Faculty of Medeine-Administrative Building sohag 82524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome efficacy of different techniques in the malleable penile prosthesis implantation, its effect on patient satisfaction, and predictors of success first 12 months after implantation
Secondary Outcome to detect complications and their pre and intra-operative predictors first 6 months after implantation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine sohag university Sohag-nasser city- Sohag University-Faculty of Medeine-Administrative Building sohag 82524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sohag university hospital at sohag faculty of medicine naser city .sohag sohag Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor eslam mohamed abdel wareth sohag akhmim street near superjet station sohag 82524 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
urology department faculty of medicine sohag university naser city sohag sohag Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eslam abdel wareth eslamwareth@gmail.com 00201008724387 sohag akhmim street near superjet station
City Postal code Country Position/Affiliation
sohag Egypt assistant lecturer urology department faculty of medicine sohag university
Role Name Email Phone Street address
Public Enquiries hazem elmoghazy moghazyh@gmail.com 00201096522289 alzahra street sohag
City Postal code Country Position/Affiliation
sohag Egypt associate professor of urology faculty of medicine sohag university
Role Name Email Phone Street address
Scientific Enquiries ahmed elsharkawi sharkawiahmed@yahoo.com 00201068056074 15 street sohag
City Postal code Country Position/Affiliation
sohag Egypt associate professor of urology faculty of medicine sohag university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Statistical Analysis Plan,Study Protocol starting from 1 June 2023 ending 1 January 2024 it will be open
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 - 29/04/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information