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.: PACTR202302505126575 Date of Approval: 01/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EPIDEMIOLOGY OF PELVIC ORGAN PROLAPSE IN SIDAMA NATIONAL REGIONAL STATE, ETHIOPIA
Official scientific title Effect of Pelvic Floor Muscle Training on Prolapse Symptoms and Quality of Life in Sidama National Regional state, Ethiopia
Brief summary describing the background and objectives of the trial Pelvic Organ Prolapse is a disorder of a woman's pelvic floor characterized by the descent of the uterus, bladder, rectum, or bowel. It is common both in developed and underdeveloped countries. When diagnosed objectively, the prevalence exceeds 50% in general women and increases with age and parity. However, due to the asymptomatic nature of the disease, many women do not seek treatment and suffer from the problem. It affects women’s quality of life highly. However, evidence on the prevalence of the disease and the effectiveness of conservative treatment is lacking in low-income countries. Therefore, This study is planned to evaluate the effect of pelvic floor muscle training for the management of pelvic organ prolapse symptoms and its impact on health-related quality of life in the Sidama region, Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Pelvic Floor Disoeder
Purpose of the trial Treatment: Other
Anticipated trial start date 27/02/2023
Actual trial start date
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pelvic Floor Muscle Training ten long and ten short squeezes (contraction) done three times per day Fifteen weeks Among women diagnosed to have symptomatic stage I-III pelvic organ prolapse, 136 will be assigned to the interventional and control groups based on their pre-assigned enumeration area (cluster). Those assigned to intervention will receive pelvic floor muscle training and prolapse lifestyle advice focusing on constipation, chronic coughing, heavy lifting, and other medical conditions. The control group will receive only lifestyle modification but not trained on pelvic floor muscle exercise. Detailed counseling will be provided using a translated Sidaamu Afoo version of a leaflet (Annex-IV) (87). In the interventional group, at the initial visit, women will be informed about their stage of POP, type of prolapse (anterior, posterior, or central), the advantage of pelvic floor muscle exercise, and how it works. The detail of exercise and follow-up schedule will be explained in detail in a private room for 30-40 minutes. They will be trained to sit or lie comfortably, train pelvic muscles with 10 times 10-second maximum holds, and 10 fast contractions. This will be repeated at least three times per day (morning, afternoon, and night) (42, 87). They will be invited to attend five visits (at weeks 0, 2, 6, 10, and 15) at a nearby health facility. Five visits are preferred because 15 weeks intensive training is recommended to get adequate muscle strength) (162). At the initial visit, they will be given a diary where they record (tally) the duration and frequency of exercise they practiced. In case they cannot make a tally, a different color and size of buttons will be provided (larger black buttons represent the number of days per week they perform the training, medium red buttons represent the frequency of training performed per day and the white small buttons represent the number of contractions performed). They will put buttons in a given box each day they perform the training and this will be checked on each visit. To ensure participants' follow-up, the respective 68
Control Group Life style Modification Fifteen weeks Pelvic organ prolapse is not a life-threatening disorder, and not all prolapses deteriorate; in fact, some may improve. If you have been told you have a pelvic organ prolapse, you might want to consider the following options: • Do nothing and wait for your symptoms to improve. • Develop healthy bladder and bowel habits • Change your lifestyle to lessen downward pressures in your pelvis, especially if any of your current activities aggravate your symptoms, such as weight reduction or avoiding or reducing the amount of lifting you do. 68 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women who will be diagnosed to have symptoms of POP as diagnosed by POP-SS and confirmed POP stage I-III on pelvic examination Women who planned to leave the study area within six months (study period). Severely ill women, Women with psychiatry disorders, Women with delivered myoma or Women who want to have prolapse surgery within six months will be excluded 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 80 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 10/05/2022 Hawassa University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Hawassa University, College of Medicine and Health Sciences Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcome variable of this study is a change in Pelvic Organ Prolapse Symptom as measured by POP-SS and the intervention is Pelvic Muscle Training September 2023
Secondary Outcome The primary outcome variable of this study is a change in Health-Related Quality of Life (HRQL). The intervention is Pelvic Floor Muscle Training and other covariates include the degree of POP, the severity of POP-SS, adherence to Pelvic Floor Muscle Training protocol, maternal age, location of POP (anterior, posterior, or apical), number of childbirth, level of education, history of depression, need for fertility, body mass index, trauma, marital status, occupation, age at first delivery, place of delivery, history of prolonged labor, medical problem (chronic cough, diabetes mellitus0. September, 2023
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Motto Health Center Dale Districts, Sidama National Regional State, Ethiopia Hawassa 1560 Ethiopia
Bokaso Health Center Wonsho district Hawassa Ethiopia
Hankute Health Center Wonsho District Hawassa Ethiopia
Aposto Health Center Dale District Hawassa Ethiopia
Magara Health Center Dale District Hawassa Ethiopia
Dagiya Health Center Dale District Hawassa Ethiopia
Gidamo Health Center Dale District Hawassa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Minnesota Minneapolis and Saint Paul Minnesota United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Minnesota Minneapolis and Saint Paul Minnesota United States of America University
COLLABORATORS
Name Street address City Postal code Country
Maternal Health Fund San Jose California 1270 United States of America
Worldwide Fistula Fund Woodfield Road, Suite 350 Schaumburg United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Melese Siyoum melesesiyoum755@gmail.com +251912780577 Hawassa University
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Hawassa University College of Medicine and Health Sciences
Role Name Email Phone Street address
Scientific Enquiries Ayalew Astatkie ayalewastatkie@gmail.com +25111739694 Hawassa University College of Medicine and Health Sciences
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Hawassa University College of Medicine and Health Sciences
Role Name Email Phone Street address
Public Enquiries Biniyam Sirak veitsam123@gmail.com +251911384899 Yirgalem
City Postal code Country Position/Affiliation
Hawassa Ethiopia Yirgalem Hamlin Fistula Center
Role Name Email Phone Street address
Public Enquiries Rahel Nardos nardosr@umn.edu +16126263700 Minnesota
City Postal code Country Position/Affiliation
Minnesota United States of America Minnesota University
Role Name Email Phone Street address
Public Enquiries Wondwosen Teklesilasie wodeti@yahoo.com +251911424432 Hawassa University
City Postal code Country Position/Affiliation
Hawassa Ethiopia Hawassa University College of Medicine and Health Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification Clinical Study Report After Publication Approval from Hawassa University
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