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.: PACTR201607001696163 Date of Approval: 27/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Modified Needleless Single-Incision Mini-Sling
Official scientific title Modified Needleless Single-Incision Mini-Sling Compared to Standard Trans-Obturator Mid-Urethral Sling in the Surgical Management of Female Stress Urinary Incontinence
Brief summary describing the background and objectives of the trial the study aimed to compare the subjective and objective cure rates, and the safety of using modified needleless single-incision mini-sling in the surgical treatment of female stress urinary incontinence compared to the standard trans-obturator mid-urethral sling.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Female stress urinary incontinence,Surgery,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2013
Actual trial start date 01/02/2013
Anticipated date of last follow up 03/08/2015
Actual Last follow-up date 02/12/2015
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised computer selection closed envelop Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group minisling n/a n/a n/a 50
Control Group TOT n/a n/a transobturator tape 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients included were diagnosed to have a urodynamic stress urinary incontinence and positive cough stress test, with or without associated genital prolapse (Grade one only). o Exclusion criteria: Women with over-active bladder, age is less than 25 or more than 35, normal vaginal delivery > 3, BMI > 30 kg /m2, Patient undergo previous surgical procedures for treatment of SUI, Pelvic organ prolapse > grade two 20 Year(s) 40 Year(s) Female
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 04/01/2013 Ain Shams University ethical committe
Ethics Committee Address
Street address City Postal code Country
ramses street cairo 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome correction of stress incontinence after 1 and 3 and 6 months
Secondary Outcome time of the operation one hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ainshams university maternity hospital abbaseya cairo 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
n/a n/a n/a n/a Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams university ramses cairo 12345 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ain shams university ramses cairo 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohammed elsokkary mohammedelsokkary1@yahoo.com 0201001574386 abbasya
City Postal code Country Position/Affiliation
cairo 12345 Egypt ainshams
Role Name Email Phone Street address
Public Enquiries mohammed elsokkary mohammedelsokkary1@yahoo.com 0201001574386 abbasya
City Postal code Country Position/Affiliation
cairo 12345 Egypt ainshams
Role Name Email Phone Street address
Scientific Enquiries mohammed elsokkary mohammedelsokkary1@yahoo.com 0201001574386 abbasya
City Postal code Country Position/Affiliation
cairo 12345 Egypt ainshams
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information