Clinical trial NCT06729359: Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women
Official title: Polycystic Ovary Syndrome and Urinary Tract Stones: a BMI-Adjusted Analysis in Iraqi Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PCOS (Polycystic Ovary Syndrome)
Stone, Urinary
BMI
Obesity
Overweight
Underweight
Keywords: PCOS (Polycystic Ovary Syndrome)
stone, urinary
BMI
Obesity
Overweight
Underweight
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 407
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study recruited two groups of females attending the gynecology and obstetrics outpatient clinic at Al-Elwiya Maternity Teaching Hospital. the first group contains women diagnosed with PCOS (Polycystic Ovary Syndrome) and the second group contains normal women attending the clinic for other causes that do not affect the body weight or the hormonal balance of the body

Brief summary: The goal of this observational case-control study is to find out the impact of PCOS as a risk factor for the presence of urinary tract stones taking into account the BMI of women aged 18-40 years consulting the gynecology and obstetrics outpatient clinic at Al-Elwiya Maternity Teaching Hospital.

The study aims to collect information from approximately 200 women with polycystic ovary syndrome and 200 volunteers who do not have PCOS.

A written consent was obtained from all the participants. The information collected included age, weight, and height. In addition, focused history and clinical examination were conducted for all patients, and for some patients, one or more additional blood tests were obtained. The additional tests included but not limited to serum levels of testosterone, dehydroepiandrosterone sulfate (DHEA-S), androstenedione, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and sex hormone-binding globulin. Moreover, ultrasonography of the abdomen and pelvis was obtained for all patients as part of the diagnosis of PCOS and as screening for urinary tract stones. Also, transvaginal ultrasonography was obtained for some patients according to the individual condition as requested by the treating gynecologist. The diagnosis ofc PCOS was based on the Rotterdam criteria. (1)

The main questions the study aims to answer are:

* Is PCOS a risk factor for urinary tract stones when taking BMI into account?
* Is PCOS a risk for urinary tract stones at all?
* Is there an association between PCOS and BMI?
* Does BMI affect the presence of urinary tract stones at all and the presence of urinary tract stones when taking PCOS into account?


Eligibility criteria: Inclusion Criteria:

* female
* age 18-40 years

Exclusion Criteria:

* A medical or surgical condition that affects urinary tract stone formation.
* A medical or surgical condition that affects body weight or height.
* A medical or surgical condition that affects hormonal balance.

Primary outcomes:
measure: the association between PCOS (Polycystic Ovary Syndrome) and the presence of urinary tract stones controlled for BMI
timeFrame: at the time of enrollment
Secondary outcomes:
measure: the association between PCOS (Polycystic Ovary Syndrome) and BMI
timeFrame: at the time of enrollment
measure: the association between BMI and the presence of urinary tract stones
timeFrame: at the time of enrollment
measure: the association between BMI and the presence of urinary tract stones controlled for the presence of PCOS (Polycystic Ovary Syndrome)
timeFrame: at the time of enrollment
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Al-Elwiya Maternity Teaching Hospital
state: Alrusafa
Study officials:
affiliation: University of Baghdad / Alkindy College of Medicine
name: Harth Mohamed Kamber, FICMS (Uro.)
role: STUDY_CHAIR
affiliation: University of Baghdad / Alkindy College of Medicine
name: Weqar Akram Hussein, FICMS (Gyn.)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Baghdad / Alkindy College of Medicine
name: Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)
role: PRINCIPAL_INVESTIGATOR
affiliation: United Lincolnshire Teaching Hospitals NHS Trust
name: Kamal Al-Jawdah, MBChB, MRCS, FIBMS
role: STUDY_DIRECTOR
References: