- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398186
The Effect of Polycystic Ovary Syndrome on Pelvic Floor Structure and Function
Polycystic Ovarian Syndrome (PCOS) is the most common endocrinological disorder in women of reproductive age, and its prevalence is reported to be 6-21% in women aged 15-49 (1). Although its etiopathogenesis is still not clear, it is known that it is due to the disregulation of ovarian steroidogenesis under the influence of some environmental and genetic factors. Diagnosis of ESHRE / ASRM has set Rotterdam criteria in 2003; one of these criteria is the presence of hyperandrogenism (2). Hyperandrogenism leads to an increase in general muscle mass in the body (1, 3, 4).
Pelvic floor muscles are associated with urethra in the anterior compartment, rectum and anus in the posterior compartment, and uterine support in the apex; major urinary and fecal continence ensuring its functions in order to stop in the appropriate position of the pelvic organs (5). The well-being of the pelvic floor muscle strength has a protective effect from urinary and fecal incontinence.
It has been emphasized that the "anogenital distance" determined by the measurement of the anal region anterior to the clitoris anterior may also be a criteria in the diagnosis of Polycystic Ovary Syndrome (7,8,9).
In this study, patients in the reproductive age between 18-40 years, who applied to our gynecology outpatient clinic and were diagnosed as PCOS according to Rotterdam criteria wil be study gorup and the women without PCOS will be control group. We aimed to evaluate the pelvic muscle strength with perineometry, to measure anogenital distance and to determine possible relationships with each other. In addition to demographic information, ICIQ-SF (Urinary incontinence inquiry short form) will also be taken to evaluate pelvic floor function (10).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Giresun, Turkey, 28100
- Sebnem Alanya Tosun
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Nulliparity
Exclusion Criteria:
- Endocrine disorders
- Anabolic drug usage Multiparity
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group 1
Hiperandrogenism + ultrasonographic PCO
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Measurements of AGD and perineal muscle strength
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Study group 2
Menstruel cycle irregular + ultrasonographic PCO
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Measurements of AGD and perineal muscle strength
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Study group 3
Menstruel cycle irregular + ultrasonographic PCO + hyperandrogenism
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Measurements of AGD and perineal muscle strength
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Control group
Do not have PCOS
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Measurements of AGD and perineal muscle strength
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anogenital distance measurement in PCOS
Time Frame: 01.06.2020- 01.11.2020
|
01.06.2020- 01.11.2020
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Neoplasms
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Urination Disorders
- Elimination Disorders
- Polycystic Ovary Syndrome
- Syndrome
- Urinary Incontinence
- Enuresis
Other Study ID Numbers
- GiresunU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polycystic Ovary Syndrome
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Cairo UniversityCompleted
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Alexandria UniversityRecruitingPolycystic Ovary Syndrome (PCOS)Egypt
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Saudi German Hospital - MadinahCompletedPolycystic Ovary Syndrome (PCOS)Saudi Arabia
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University of CopenhagenCompletedPolycystic Ovary Syndrome (PCOS)Denmark
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Odense University HospitalCompleted
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Assaf-Harofeh Medical CenterUnknownInfertility | Polycystic OvariesIsrael
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Poznan University of Medical SciencesUniversity of California, DavisUnknownPolycystic Ovary Syndrome (PCOS)Poland
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Riphah International UniversityCompleted
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Dexa Medica GroupCompletedPolycystic Ovary Syndrome (PCOS)Indonesia
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Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminatedPolycystic Ovary Syndrome (PCOS)United States
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