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

March 28, 2025 updated by: Başakşehir Çam & Sakura City Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34480
        • Başakşehir Çam ve Sakura Şehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

This study included a total of 147 pregnant women in their third trimester (≥30 weeks) recruited from the obstetrics department. Participants were categorized into four groups: type 1 diabetes mellitus (T1DM) (n = 16), type 2 diabetes mellitus (T2DM) (n = 32), gestational diabetes mellitus (GDM) (n = 51), and a control group (CG) comprising healthy pregnant women with uncomplicated pregnancies (n = 48). Eligible participants were aged between 18 and 40 years and in good physical and mental health. Inclusion criteria required a singleton pregnancy with a gestational age of at least 30 weeks and no history of known urological disorders. Exclusion criteria included multiple pregnancies, chronic kidney disease, and prior urogynecological surgery.

Description

Inclusion Criteria:).

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T1DM group
type 1 diabetes mellitus group (n = 16)
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
T2DM group
type 2 diabetes mellitus group (n = 32)
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
GDM group
gestational diabetes mellitus group (n = 51)
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
control group (CG)
consisting of healthy pregnant women with uncomplicated pregnancies (n = 48).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the time of inclusion in the study until the first postpartum month.
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,
From the time of inclusion in the study until the first postpartum month.
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.
From the time of inclusion in the study until the first postpartum month.
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.
From the time of inclusion in the study until the first postpartum month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

March 15, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cam ve Sakura Sehir Hastanesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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