Clinical trial NCT06902155: Impact of Diabetes Subtypes on Urinary Incontinence During Pregnancy and Postpartum: A Study on BMI and Glycemic Control
Official title: Impact of Diabetes Subtypes on Urinary Incontinence During Pregnancy and Postpartum: A Study on BMI and Glycemic Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Diabetes Mellitus
Keywords: Urinary incontinence
pregnancy
diabetes mellitus
Body mass index
glycemic control.
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-30
Enrollment: 147
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Maternal serum HbA1c levels for pregnancy-related and postpartum UI
timeFrame: From the time of inclusion in the study until the first postpartum month.
measure: BMI for pregnancy-related and postpartum UI
timeFrame: From the time of inclusion in the study until the first postpartum month.
measure: insulin use for pregnancy-related and postpartum UI
timeFrame: From the time of inclusion in the study until the first postpartum month.
measure: maternal age and history of urinary tract infection for pregnancy-related and postpartum UI
timeFrame: From the time of inclusion in the study until the first postpartum month.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura Sehir Hastanesi
Study officials:
References:
citation: Vesentini G, Piculo F, Marini G, Barbosa AMP, Corrente JE, Rudge MVC. Impact of Obesity and Hyperglycemia on Pregnancy-specific Urinary Incontinence. Rev Bras Ginecol Obstet. 2023 Jun;45(6):303-311. doi: 10.1055/s-0043-1770087. Epub 2023 Jul 21.
citation: Valerio PM, Zordao CC, Goncalves VE, Hasegawa MSR, Jorge CH, Moises ECD, de Oliveira Guirro EC. Urinary Incontinence in the Third Trimester of Pregnancy of Type 1 Diabetic Women. Reprod Sci. 2024 Jun;31(6):1558-1564. doi: 10.1007/s43032-024-01488-w. Epub 2024 Mar 4.