The Effect of Polycystic Ovary Syndrome on Pelvic Floor Structure and Function

Sponsor
Giresun University (Other)
Overall Status
Completed
CT.gov ID
NCT04398186
Collaborator
(none)
90
Enrollment
1
Location
9
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Anogenital distance measurement

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Polycystic Ovary Syndrome on Pelvic Floor Structure and Function
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Study group 1

Hiperandrogenism + ultrasonographic PCO

Diagnostic Test: Anogenital distance measurement
Measurements of AGD and perineal muscle strength

Study group 2

Menstruel cycle irregular + ultrasonographic PCO

Diagnostic Test: Anogenital distance measurement
Measurements of AGD and perineal muscle strength

Study group 3

Menstruel cycle irregular + ultrasonographic PCO + hyperandrogenism

Diagnostic Test: Anogenital distance measurement
Measurements of AGD and perineal muscle strength

Control group

Do not have PCOS

Diagnostic Test: Anogenital distance measurement
Measurements of AGD and perineal muscle strength

Outcome Measures

Primary Outcome Measures

  1. Anogenital distance measurement in PCOS [01.06.2020- 01.11.2020]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Nulliparity
Exclusion Criteria:
  • Endocrine disorders

  • Anabolic drug usage Multiparity

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Sebnem Alanya TosunGiresunTurkey28100

Sponsors and Collaborators

  • Giresun University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sebnem Alanya Tosun, Assistant Professor, Giresun University
ClinicalTrials.gov Identifier:
NCT04398186
Other Study ID Numbers:
  • GiresunU
First Posted:
May 21, 2020
Last Update Posted:
Mar 2, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sebnem Alanya Tosun, Assistant Professor, Giresun University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2021