Skip to main content
OpenTrials
Completed

NCT Number: NCT06902155

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

).

  • Aged between 18 and 40 years
  • Had good physical and mental health.
  • Had singleton pregnancy
  • Had no history of known urological disorders
  • At least 30 weeks gestational aged , pregnants

Exclusion criteria

  • multiple pregnancies
  • pregnants with chronic kidney disease, and prior urogynecological surgery.

Treatment and study plan

International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

Diagnostic Test

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

Primary outcomes

  1. Maternal serum HbA1c levels for pregnancy-related and postpartum UI

    Time frame: From the time of inclusion in the study until the first postpartum month.

    HbA1c levels were significantly associated with an increased severity of incontinence in women with GDM.

  2. BMI for pregnancy-related and postpartum UI

    Time frame: From the time of inclusion in the study until the first postpartum month.

    BMI was a strong predictor of postpartum incontinence persistence in both the type 1 diabetes and GDM groups,

  3. insulin use for pregnancy-related and postpartum UI

    Time frame: From the time of inclusion in the study until the first postpartum month.

    insulin use did not significantly impact UI severity during pregnancy in any of the diabetes subgroups.

  4. maternal age and history of urinary tract infection for pregnancy-related and postpartum UI

    Time frame: From the time of inclusion in the study until the first postpartum month.

    maternal age and history of urinary tract infection were not significantly associated with UI severity or postpartum incontinence in any diabetes group.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.