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.: PACTR202008862941254 Date of Approval: 24/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Biofeedback pelvic floor muscle training and posterior tibial nerve stimulation for treatment of faecal incontinence: monotherapy versus combined therapy:A prospective controlled randomized trial
Official scientific title Biofeedback pelvic floor muscle training and posterior tibial nerve stimulation for treatment of faecal incontinence: monotherapy versus combined therapy:A prospective controlled randomized trial
Brief summary describing the background and objectives of the trial Faecal Incontinence is a common anorectal problem among adult population. with many methods of treatment. the objective of this trial is to compare the efficacy of biofeedback pelvic floor muscle training versus posterior tibial nerve electrostimulation versus combination of both of them in treatment of patients with faecal incontinence.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2018
Actual trial start date 15/07/2018
Anticipated date of last follow up 01/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Biofeedback pelvic floor muscle training Biofeedback pelvic floor muscle training session lasted 20-30 minutes 6 weeks The pressure-based BF pelvic floor muscle training was done using Myomed 632-equipment 20 Active-Treatment of Control Group
Experimental Group posterior tibial nerve stimulation 200 μs; current frequency of 10 Hz and intensity 6 weeks transcutaneous posterior tibial nerve stimulation 20
Experimental Group Biofeedback pelvic floor muscle training and posterior tibial nerve stimulation Biofeedback pelvic floor muscle training session lasted 20-30 minutes and posterior tibial nerve stimulation pulse width of 200 μs; current frequency of 10 Hz 6 weeks pressure-based BF pelvic floor muscle training and transcutaneous posterior tibial nerve stimulation 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with idiopathic, postoperative, postpartum, traumatic or rectal prolapse faecal incontinence were older than 18 years duration of FI of at least 6 months failure of medical therapy for faecal incontinence. diabetes mellitus metabolic disorders endocrine disorders diarrhea inflammatory bowel diseases neurological diseases leading to neurogenic bowel disorders and overflow faecal incontinence Contraindications for BF training as depression, mental health problem affecting the ability for concentration and learning. Contraindications for PTNS as neurological disorders affecting the lower limbs as peripheral neuropathy, current skin or soft tissue infection at or near the site of application of the transcutaneous PTNS and patient with cardiac pacemaker or cardiac defibrillator. Pregnancy traumatic faecal incontinence if the defect is more than 25% of the circumference e Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 70 Year(s) Both
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 19/07/2018 Ethics Committee of the Faculty of Medicine Alexandria University Egypt.
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine. 17 champollion street. Alexandria Egypt. Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparison between improvement of Wexner Faecal Continence scale Wexner Faecal Continence scale
Secondary Outcome maximal squeezing anal pressure, maximal voluntary anal contraction time and VAS for patient global assessment of effect of FI on quality of life. Anal manometry assessment and VAS for patient global assessment of effect of FI on quality of life
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Faculty of Medicine El Raml Station, Alexandria , Egypt Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
main University hospital Faculty of Medicine Alexandria University Faculty of Medicine. 17 champollion street Alexandria, Egypt. Alexandri a 21563 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Alexandria University Egypt. Faculty of Medicine. 17 champollion street Alexandria, Egypt. Alexandria 21563 Egypt University
COLLABORATORS
Name Street address City Postal code Country
none none none 0000000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mervat Elsawy Elsawy shetasawy@yahoo.com 0201020130415 Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine,17 champolion street Alexandria Governorate, Egypt
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Lecturer Physical Medicine Rheumatology and Rehabilitation Department Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Principal Investigator Khaled Abbas khassan@kku.edu.sa 00966542499974 King Khalid University Faculty of Medicine Department of General Surgery
City Postal code Country Position/Affiliation
Abha 61421 Saudi Arabia Associate Professor General Surgery Department Faculty of Medicine King Khalid University
Role Name Email Phone Street address
Principal Investigator Emmanuel Saba emadaziz55@yahoo.com 0201224718376 Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine,17 champolion street Alexandria Governorate, Egypt
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Assistant professor Physical Medicine Rheumatology and Rehabilitation Department Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Public Enquiries Mervat Elsawy shetasawy@yahoo.com 0201020130415 Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine,17 champolion street Alexandria Governorate, Egypt
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Lecturer Physical Medicine Rheumatology and Rehabilitation Department Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mervat Elsawy shetasawy@yahoo.com 0201020130415 Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine,17 champolion street Alexandria Governorate, Egypt
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Lecturer Physical Medicine Rheumatology and Rehabilitation Department Faculty of Medicine Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary results within the trial registration record. This will be done within 6 months of the study completion date Informed Consent Form,Study Protocol within 6 months of data completion patients IDs will be concealed, otherwise, access to data 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 URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 23/08/2020 correct the name Faculty of Medicine Alexandria University, Faculty of Medicine. 17 champollion street Alexandria, Egypt., Alexandri a, 21563, Egypt, Self Funded, main University hospital Faculty of Medicine Alexandria University, Faculty of Medicine. 17 champollion street Alexandria, Egypt., Alexandri a, 21563, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 23/08/2020 It was an editing mistakeas we did not realize that self-funding was an option Faculty of Medicine Alexandria University, Faculty of Medicine. 17 champollion street Alexandria, Egypt., Alexandri a, 21563, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 23/08/2020 The system is not accepting the "no" answer. So we had to chose "yes" and state that there are no collaborators none, none, none, 0000000, Egypt
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 23/08/2020 we were unaware of these recommendations before summary results within the trial registration record. This will be done within 6 months of the study completion date
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 23/08/2020 we were unaware of these recommendations before within 6 months of data completion
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 23/08/2020 we were unaware of these recommendations before patients IDs will be concealed, otherwise, access to data will be open
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 23/08/2020 we were unaware of these recommendations before Study Protocol, Informed Consent Form