NCT04398186

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

Completed Last updated 2 March 2021

What this trial tests

trial testing Anogenital distance measurement in Reproductive System Disorder in 90 participants. Completed in 1 March 2021.

Timeline

1 June 2020

Primary endpoint
30 October 2020

1 March 2021

Quick facts

Lead sponsor	Giresun University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	90
Start date	1 June 2020
Primary completion	30 October 2020
Estimated completion	1 March 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Anogenital distance measurement

Conditions studied

• Reproductive System Disorder — all drugs for Reproductive System Disorder →
• Urinary Incontinence — all drugs for Urinary Incontinence →
• Urogenital Disease — all drugs for Urogenital Disease →
• Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →

Sponsor

Giresun University

Who can join

Adults 18 to 40, female only, with Reproductive System Disorder or Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.