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.: PACTR202403668137704 Date of Approval: 20/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of high-intensity focused electromagnetic therapy on pelvic floor muscles and sexual dysfunction postmenopausal women.
Official scientific title Effect of high-intensity focused electromagnetic therapy on pelvic floor muscles and sexual dysfunction postmenopausal women.
Brief summary describing the background and objectives of the trial Postmenopausal women frequently suffer from pelvic floor muscle weakness and sexual dysfunctions due to estrogen deficiency at this stage of the life cycle which generates atrophic changes in the pelvic flor muscles and vaginal and periurethral tissues. Among the options based on non-invasive and non-pharmacological intervention are therapeutic targeted exercise which focuses on improving the function, muscle tone, strength, coordination, and endurance of the pelvic-floor musculature. High-intensity focused electromagnetic therapy triggers intense pelvic floor muscle contractions by depolarizing motoneurons and inducing electric currents in the pelvic floor area. The focused electromagnetic energy penetrates into the depth of up to10 cm into the pelvic floor area where it induces supramaximal and brain-independent contractions at high repetition rates to the pelvic floor muscles. So, the objective of this study is to evaluate the effect of high-intensity focused electromagnetic therapy on pelvic floor muscles and sexual dysfunction postmenopausal women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Rehabilitation
Anticipated trial start date 14/02/2023
Actual trial start date 28/02/2023
Anticipated date of last follow up 02/01/2024
Actual Last follow-up date 05/01/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 58
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group High intensity focused electromagnetic therapy and Kegel exercises High-intensity focused electromagnetic therapy is 30 minutes, 2 times /week , in addition to a program of Kegel for 20 minutes, 3 times /week 12 weeks. The High-intensity focused electromagnetic device is consisted of a power generator and a circular coil mounted in the seat of the chair. During the treatment, the patient is fully clothed and seated on the center of the chair while the alternating magnetic fields with intensities of up to 2.5 T have been penetrating the pelvic area. kegel exercise is performed by instructing women to identify and feel pelvic floor muscles contractions while sitting and standing. Contract pelvic floor muscles for 3 to 5 seconds. Then relax for 3 to 5 seconds and repeat the contract/relax cycle 10 times. Gradually increase the length of contractions and relaxations up to 10-second. 30
Control Group kegel exercise 20 minutes, 3 times /week for 12 weeks 12 weeks kegel exercise is performed by instructing women to identify and feel pelvic floor muscles contractions while sitting and standing. Contract pelvic floor muscles for 3 to 5 seconds. Then relax for 3 to 5 seconds and repeat the contract/relax cycle 10 times. Gradually increase the length of contractions and relaxations. Work her way up to 10-second contractions and relaxations. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Postmenopausal women. 2. Their ages will be ranged from 45to 60 years old. 3. Their BMI will be less than 30 Kg/m2. 4. They were multipara through normal vaginal delivery. 1. Pelvic organ prolapse 2. Metal implants. 3. Pelvic tumor. 4. Blood coagulation disorder. 5. Vaginal infections. 6. Musculoskeletal/ neurological limitations to exercise. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 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 02/01/2023 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
Ahmed Elzayat Cairo 8655 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pelvic floor muscle strength (A Peritron 9300 perineometer). Before and after 12 weeks of the intervention
Secondary Outcome Sexual dysfunction (Arabic version of the female version of The Sexual Dysfunctional Beliefs Questionnaire). Before and after 12 weeks of the intervention
Secondary Outcome Quality of life (Menopause specific quality of life questionnaire) Before and after 12 weeks of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Mahalla general hospital Bahr street El Mahalla Alkobra 31953 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Saher lotfy abo ali abo ali 12611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Saher Elgayar Aboali Mahalla 12611 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
saher lotfy abo ali mahala 12611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saher Elgayar saherlotfy020@gmail.com +201020429911 Gehad
City Postal code Country Position/Affiliation
Mahalla 31951 Egypt Assistant Professor Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University
Role Name Email Phone Street address
Public Enquiries Mohamed Elhamrawy saher_lotfi@yahoo.com +201060667075 Bahrawy
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Assistant Professor Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Gamil saherelgayar@yahoo.com +201022429914 Tagamoo
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Lecturer Physical therapy for women health Faculty of Physical Therapy October University for Modern Sciences and Arts
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in carpal tunnel syndrome. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party Informed Consent Form,Statistical Analysis Plan Data requests can be submitted starting 1 month after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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