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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398186
• Other study ID #: GiresunU
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Giresun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 1, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Nulliparity

Exclusion Criteria:

• Endocrine disorders

• Anabolic drug usage Multiparity

Related Conditions & MeSH terms

• Enuresis
• Polycystic Ovary Syndrome
• Reproductive System Disorder
• Syndrome
• Urinary Incontinence
• Urogenital Disease

Intervention

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

Locations

Country	Name	City	State
Turkey	Sebnem Alanya Tosun	Giresun

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anogenital distance measurement in PCOS		01.06.2020- 01.11.2020