NCT06902155

Impact of Diabetes Subtypes on Urinary Incontinence During Pregnancy and Postpartum: A Study on BMI and Glycemic Control

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 147 (actual)
• Sponsor: Başakşehir Çam & Sakura City Hospital · Other Government
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: —

Summary

Objective: This study investigated the relationship between diabetes mellitus and urinary incontinence (UI) during pregnancy and postpartum, focusing on metabolic factors like body mass index (BMI) and glycemic control. Methods: A prospective observational study was conducted at Başakşehir Çam and Sakura City Hospital, including 147 pregnant women in their third trimester (≥30 weeks). Participants were categorized into type 1 diabetes mellitus (n = 16), type 2 diabetes mellitus (n = 32), gestational diabetes mellitus (GDM) (n = 51), and a control group (n = 48). UI was assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and metabolic parameters were retrieved from hospital records. Subgroup comparisons and ROC curve analysis were performed to determine BMI and HbA1c cut-off values for predicting postpartum UI.

Detailed description

This prospective observational study was conducted at …… between ……with participants recruited from the obstetrics department. A total of 147 pregnant women in their third trimester (≥30 weeks) were enrolled and categorized into four groups: type 1 diabetes mellitus (T1DM) group (n = 16), type 2 diabetes mellitus (T2DM) group (n = 32), gestational diabetes mellitus (GDM) group (n = 51), and a control group (CG) consisting of healthy pregnant women with uncomplicated pregnancies (n = 48). Participants were aged between 18 and 40 years and had good physical and mental health. Eligibility criteria included singleton pregnancy, gestational age of at least 30 weeks, and no history of known urological disorders, while exclusion criteria encompassed multiple pregnancies, chronic kidney disease, and prior urogynecological surgery. Maternal age, insulin use, and history of pre-pregnancy urinary incontinence (UI) were obtained through direct patient interviews. Third-trimester HbA1c levels and complete urinalysis results were extracted from the hospital's digital medical records. Urinary incontinence was assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a validated instrument with a Cronbach's alpha of 0.88. This tool consists of four items: three scored questions evaluating leakage frequency (0-5), volume (0-6), and impact on quality of life (0-10), summing to a total score of 0-21, and one unscored question identifying situations where incontinence occurs. Two separate analyses were performed: total ICIQ-SF score and responses to question 6, which identified UI-triggering situations. To minimize selection bias, only participants meeting strict inclusion and exclusion criteria were enrolled. The study size was determined based on previous studies to ensure adequate statistical power for subgroup analyses.

Conditions

• Urinary Incontinence
• Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)	Urinary incontinence was assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a validated instrument with a Cronbach's alpha of 0.88. This tool consists of four items: three scored questions evaluating leakage frequency (0-5), volume (0-6), and impact on quality of life (0-10), summing to a total score of 0-21, and one unscored question identifying situations where incontinence occurs. Two separate analyses were performed: total ICIQ-SF score and responses to question, which identified UI-triggering situations

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-03-10
• Completion: 2025-03-15
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: Turkey (Türkiye)