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)
• Enrollment: 90
• Location: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 10

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 Disease	Intervention/Treatment	Phase
Reproductive System Disorder; Urinary Incontinence; Urogenital Disease; Polycystic Ovary Syndrome	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Sebnem Alanya Tosun	Giresun		Turkey	28100

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: polycystic ovary syndrome; urinary incontinence; anogenital distance
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Urinary Incontinence; Enuresis; Syndrome

Study Results

No Results Posted as of Mar 2, 2021