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.: PACTR202008674682771 Date of Approval: 31/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PELVIC FLOOR MUSCLES TRAINING USING BIOFEEDBACK THERAPY VERSUS BILATERAL POSTERIOR TIBIAL NERVE NEUROMODULATION FOR TREATMENT OF OBSTRUCTED DEFECATION SYNDROME A RANDOMIZED CONTROLLED TRIAL
Official scientific title PELVIC FLOOR MUSCLE TRAINING USING BIOFEEDBACK THERAPY VERSUS BILATERAL POSTERIOR TIBIAL NERVE STIMULATION FOR TREATMENT OF OBSTRUCTED DEFECATION A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial The aim of this study is to compare biofeedback-guided pelvic floor exercise therapy (BFT) with bilateral posterior tibial nerve stimulation in treatment of obstructed defecation syndrome (ODS). As regard: 1. Wexner constipation score 2. Quality of life score
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ODS
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/07/2020
Actual trial start date 25/07/2020
Anticipated date of last follow up 15/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BILATERAL POSTERIOR TIBIAL NERVE STIMULATION Thirty patients diagnosed with obstructed defecation syndrome will receive sessions of 30 minutes duration each, unless the patient report pain or asks to stop the session , three times weekly of average 10 to 12 sessions will be given according to the patient improvement , 6 weeks bilateral posterior tibial nerve stimulation will be performed using trans cutaneous electrical stimulation. This will be achieved by surface adhesive electrodes placed at the site of posterior tibial nerve with negative electrode behind the medial malleolus and the positive electrode 10 cm above the negative electrode. 30
Control Group PELVIC FLOOR MUSCLE TRAINING USING BIOFEEDBACK THERAPY Thirty patients diagnosed with obstructed defecation syndrome will be subjected to biofeedback guided pelvic floor muscle exercise consists of 10 to 12 sessions of therapy 3 sessions weekly each session of 30 minutes duration unless the patient report pain or asks to stop the session 6 weeks pelvic floor muscle training using biofeedback therapy during biofeedback therapy, a special tampon-shaped sensor is inserted in the patient's rectum and in some instances; a second sensor is placed on her abdomen: • These sensors detect electrical signals from the pelvic floor muscles • The patient then is instructed to contract and relax the pelvic floor muscles upon command. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The patients are included in the study if they fulfilled Rome 4 criteria, of functional constipation 1. Previous pelvic surgery or trauma of the pelvic area and history of pelvic irradiation. 2. Neurogenic causes: Multiple Sclerosis, Parkinson Disease. 3. Hirschsprung Disease. 4. Metabolic causes: hypokalemia, hypercalcemai and hypothyroidism. 5. Chronic kidney diseases, Rheumatoid disorders, Inflammatory bowel diseases. 6. Patients with congenital anomalies in the anus or rectum. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 18/06/2020 Ethics committe of Alexandria University
Ethics Committee Address
Street address City Postal code Country
Al Sultan Hussein st, Al Khartoum Square, Al Azarita , Alexandria , Egypt /faculty of medicine of Alexandria university Alexandria 21500 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Wexner constipation score 2. Quality of life score 3 weeks
Secondary Outcome 1. Wexner constipation score 2. Quality of life score 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
colorectal surgery unit of the Alexandria Main university Hospital Sultan Hussein,Khartoum Square,Alexandria, Egypt Alexandria Egypt 21500 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Fouad Mohamed Fouad Bassyouni Ashoush Mostafa Khaled st , moharam basha , Alexandria Alexandria 21500 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Colorectal surgery unit of the Alexandria university hospital Sultan hussein st, Al khartoum Square , Al /Azarita . Alexandria Alexandria Egypt 21500 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fouad Mohamed Fouad Bassyouni Ashoush lovestory10001000@gmail.com 00201227203737 Mostafa Khaled st, oharam basha , Alexandria
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt MR Fouad Ashoush
Role Name Email Phone Street address
Public Enquiries Eman Ramadan Mansour emyramadan2008@yahoo.com 00201112454251 sultan hussein st,AlKhartoum Square ,Al azarita , Alexandria
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Prof.Dr.
Role Name Email Phone Street address
Scientific Enquiries Walid Galal Abd Alhakeem Al Shazly wshazly@gmail.com 00201221100756 13 Mustafa Hafez st ,faculty of medicine street ,Al ramll station ,Alexandria
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt Prof.Dr.
Role Name Email Phone Street address
Scientific Enquiries mohamed Sultan dr.mohsultan@gmail.com 00201003113038 138 portsaid st, sporting ,zamzam building, Alexandria
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt DR.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available ,Individual participant data that underlies the results reported in this article, after deidentification (text,tables, figures, and appendices ) Statistical Analysis Plan,Study Protocol Beginning 6 months and ending 12 months following article publication Data are available indefinitely at (Link to be included)
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