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

B

Başakşehir Çam & Sakura City Hospital

Status

Completed

Conditions

Diabetes Mellitus
Urinary Incontinence

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06902155
Cam ve Sakura Sehir Hastanesi

Details and patient eligibility

About

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.

Full 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.

Enrollment

147 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

147 participants in 4 patient groups

T1DM group
Description:
type 1 diabetes mellitus group (n = 16)
Treatment:
Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
T2DM group
Description:
type 2 diabetes mellitus group (n = 32)
Treatment:
Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
GDM group
Description:
gestational diabetes mellitus group (n = 51)
Treatment:
Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
control group (CG)
Description:
consisting of healthy pregnant women with uncomplicated pregnancies (n = 48).
Treatment:
Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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