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

NCT04398186 | Completed

• 1 other identifier: GiresunU
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Reproductive System Disorder; Urinary Incontinence; Urogenital Disease; Polycystic Ovary Syndrome

Keywords

polycystic ovary syndrome; urinary incontinence; anogenital distance

Outcome Measures

Primary Outcomes (1)

• Anogenital distance measurement in PCOS

  01.06.2020- 01.11.2020

Study Arms (4)

Study group 1

Hiperandrogenism + ultrasonographic PCO

Diagnostic Test: Anogenital distance measurement

Study group 2

Menstruel cycle irregular + ultrasonographic PCO

Diagnostic Test: Anogenital distance measurement

Study group 3

Menstruel cycle irregular + ultrasonographic PCO + hyperandrogenism

Diagnostic Test: Anogenital distance measurement

Control group

Do not have PCOS

Diagnostic Test: Anogenital distance measurement

Interventions

Anogenital distance measurement DIAGNOSTIC_TEST

Measurements of AGD and perineal muscle strength

Control group; Study group 1; Study group 2; Study group 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Reproductive aged females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Reproductive aged females, age between 18-40 yrs.

You may qualify if:

• Nulliparity

You may not qualify if:

• Endocrine disorders
• Anabolic drug usage Multiparity

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Sebnem Alanya Tosun

Giresun, 28100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Urogenital Diseases; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: June 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: March 1, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-03

Locations

TU (1)