Impact of Diabetes Subtypes on Urinary Incontinence During Pregnancy and Postpartum: A Study on BMI and Glycemic Control
NCT ID: NCT06902155
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
147 participants
OBSERVATIONAL
2024-12-10
2025-03-15
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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T1DM group
type 1 diabetes mellitus group (n = 16)
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)
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)
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).
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
2. pregnants with chronic kidney disease, and prior urogynecological surgery.
20 Years
40 Years
FEMALE
No
Sponsors
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Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
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Locations
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Basaksehir Cam ve Sakura Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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Cam ve Sakura Sehir Hastanesi
Identifier Type: -
Identifier Source: org_study_id
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