Plain English Summary
Background and study aims
Pelvic organ prolapse can be both hereditary (born with it) and acquired. It occurs when the pelvic organ like the bladder drops from its normal place and pushes against the vagina walls. During last decade, the role of genetics in POP becomes profoundly obvious. Scandinavian twin studies have shown that there is a high consistency for pelvic disorders and that genetic factors are reaching up to 40%. Collagen is playing a major role in pelvic floor supportive structures. Connective tissues contain of type I collagen (COL1A1), giving strength to the ligaments due to the length and thickness of the fibers, and type III collagen (COL3A1), an increased amount of which is associated with a decrease in the mechanical strength of the connective tissue. The role of single nucleotide polymorphism (SNP) of the COL1A1 or COL3A1 or COL18A1 genes remain controversial. Some studies and meta-analysis found a strict correlation between these genetic defects and POP; other investigators did not confirm it. The aim of the study is to investigate the role of these SNPs in women suffering pelvic floor prolapse and women without pelvic disorders.
Who can participate?
Women aged 18 and older who have pelvic organ prolapse and women without it.
What does the study involve?
Participants are giving a saliva sample in order to perform a genetic test. The medical history is collected and filed; pelvic floor physical exam will be done. The saliva samples are analyzed for single nucleotide polymorphisms COL3A1 (rs1800255, rs1801184, rs111929073); in COL1A1 (rs1800012); in COL18A1 (rs2236479).
What are the possible benefits and risks of participating?
The benefit for participants would be to have information about genetic collagen related risk factors for connective tissue diseases. There are no anticipated disadvantages or risks to participants in taking part in this study. Whichever group they are allocated to, the tests and assessments are performed by competent and trained clinicians.
Where is the study run from?
This study is being run by the Moscow State University of Medicine and Dentistry and takes place in Urology Department in the Moscow City Hospital (Russia).
When is the study starting and how long is it expected to run for?
September 2016 to September 2018
Who is funding the study?
Ministry of Health of Russian Federation (Russia)
Who is the main contact?
Dr George Kasyan
Trial website
Contact information
Type
Scientific
Primary contact
Prof George Kasyan
ORCID ID
http://orcid.org/0000-0001-7919-2217
Contact details
Vucheticha 21
Moscow
126209
Saint Helena
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05/2016
Study information
Scientific title
Single nucleotide polymorphisms in type 1 and 3 collagens in women suffering pelvic organ prolapse
Acronym
SNPs in COL1 and COL3 for Pelvic organ prolapse
Study hypothesis
The single nucleotide polymorphisms in collagen type 1 alpha 1 or type 3 alpha 1 genes may play a role in development of pelvic organ prolapse in women.
Ethics approval
Ethics Board of Moscow State University of Medicine and Dentistry, 01/06/2016, ref: # 05-17
Study design
Prospective case-control study that included women with pelvic organ prolapse and the group of control
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pelvic organ prolapse has a mixed etiology – hereditary and acquired. Collagen is playing a major role in pelvic floor supportive structures. The role of single nucleotide polymorphism of the collagen genes remain controversial. This inconsistency has resulted in the current study in which several polymorphisms in collagen in saliva samples of women will be investigated.
Intervention
This is cross sectional case-control study evaluating the prevalence of single nucleotide polymorphism (SNP) in collagen type 3 alpha 1 chain (COL3A1), collagen type 1 alpha 1 chain (COL1A1) and collagen type 18 alpha 1 chain (COL18A1) genes in patients with pelvic organ prolapse or in control group.
Patient information are extracted from the database of the University Urology Clinic. Patients previously operated for pelvic organ prolapse are contacted via nurse phone call. They are informed about the study and invited for a visit. The control group includes parous women without pelvic organ prolapse.
During the screening visit, participant information and informed consent are provided to women. During the first visit, participants sign informed consent and provide a saliva sample for genetic investigations. The results of the tests are sent to the participants via emails.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
Single nucleotide polymorphisms in COL3A1 is investigated using Sanger gene sequencing method.
Secondary outcome measures
1. Single nucleotide polymorphisms in COL1A1 gene is measured using Sanger gene sequencing method
2. Single nucleotide polymorphisms in COL 18A gene is measured using Sanger gene sequencing method
Overall trial start date
15/09/2016
Overall trial end date
01/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult women suffering from pelvic organ prolapse and healthy women as controls
2. Aged 18 and older
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
250
Participant exclusion criteria
Hereditary diseases with a known increased risk of POP, such as Marfan or Ehlers-Danlos syndrome and previous surgeries for POP for the control group
Recruitment start date
01/01/2017
Recruitment end date
01/06/2018
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Urology Department of Moscow State University of Medicine and Dentistry
Vucheticha 21
Moscow
127206
Russian Federation
Sponsor information
Organisation
Ministry of Health of Russian Federation
Sponsor details
Rakhmanov Pereulok 3
Moscow
127994
Russian Federation
+7 4956272400
info@rosminzdrav.ru
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Russian Academy of Medical Sciences
Alternative name(s)
RAMS
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Russian Federation
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. All additional documents are available in Russian in the study file. Not available in web format, please use the contact details below to request a patient information sheet.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Investigators: George Kasyan, Dmitry Vishnevsky at study contact address: urodep@msmsu.ru, tel/fax +7 499 760 75 89
Intention to publish date
01/06/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://biomedres.us/fulltexts/BJSTR.MS.ID.001557.php (added 06/09/2019)
2019 results in: https://lupinepublishers.com/urology-nephrology-journal/special-issue/JUNS.MS.ID.000129.pdf (added 06/09/2019)