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.: PACTR202009762113535 Date of Approval: 02/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Biofeedback pelvic floor muscle training versus transcutaneous posterior tibial nerve electrostimulation in treatment of functional obstructed defecation : A prospective controlled randomized trial.
Official scientific title Biofeedback pelvic floor muscle training versus transcutaneous posterior tibial nerve electrostimulation in treatment of functional obstructed defecation : A prospective controlled randomized trial.
Brief summary describing the background and objectives of the trial Functional obstructed defecation is a common anorectal problem among adult population.The aim of the current study is to compare the efficacy of biofeedback pelvic floor muscle training (BF) versus posterior tibial nerve electrostimulation (PTNS) in treatment of patients with functional obstructed defecation.
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 01/08/2018
Actual trial start date 15/08/2018
Anticipated date of last follow up 15/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 41
Actual target sample size (number of participants) 41
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 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 session lasted 20-30 minutes, two sessions per week 6 weeks The pressure-based Biofeedback pelvic floor muscle training was done using Myomed 632-equipment 21 Active-Treatment of Control Group
Experimental Group posterior tibial nerve stimulation 200 μs; current frequency of 10 Hz and intensity, session is 30 minute, three sessions per week 6 weeks transcutaneous posterior tibial nerve stimulation 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
functional obstructed defecation unresponsive to conservative treatment for at least 3 months. older than 18 years pregnancy diabetes mellitus endocrine disorders metabolic disorders slow transit syndrome congenital anomalies in the anus or rectum inflammatory bowel disorders irritable bowel disorder previous abdominal and/or pelvic surgeries mechanical OD due to organic lesions as rectocele and rectal intussusception neurogenic bowel disorders patients not willing to participate in the study. contraindications for BF training as mental health problem affecting the ability for concentration and learning contraindications for PTNS as neurological disorders affecting the lower limbs as peripheral neuropathy and lumbosacral plexopathy, current skin or soft tissue infection at ornear the site of application of the transcutaneous PTNS and patients with cardiac pacemaker 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 Primary outcome comparison between improvement of modified obstructed defecation score modified obstructed defecation score
Secondary Outcome Patient Assessment of Constipation-Quality of Life , time of toileting and maximum anal pressure during straining to evacuate PAC-QoL questionnaire, Anal manometry assessment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Faculty of Medicine El Raml Station, Alexandria , Egypt Alexandria 21563 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Alexandria University Faculty of Medicine. 17 champollion street Alexandria, Egypt., Alexandria 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 000000000 Egypt
CONTACT PEOPLE
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
Principal Investigator 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
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
Public Enquiries 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
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