Urinary IncontinenceNCT06902155
Impact of Diabetes Subtypes on Urinary Incontinence During Pregnancy and Postpartum: A Study on BMI and Glycemic Control
An observational study of Urinary Incontinence and Diabetes Mellitus, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Urinary Incontinence, Diabetes Mellitus
- What is being tested?
- International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
- How many people
- 147 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 15 Mar 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- multiple pregnancies
- pregnants with chronic kidney disease, and prior urogynecological surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam ve Sakura Sehir Hastanesi
Istanbul, 34480
About this study
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.
Read the 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.
- Conditions
- Urinary Incontinence, Diabetes Mellitus
- Being tested
- International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
- Keywords
- Urinary incontinence, pregnancy, diabetes mellitus, Body mass index, glycemic control.
- Medical subject headings
- Urinary Incontinence, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| T1DM group | type 1 diabetes mellitus group (n = 16) Receives: Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) | |
| T2DM group | type 2 diabetes mellitus group (n = 32) Receives: Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) | |
| GDM group | gestational diabetes mellitus group (n = 51) Receives: Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) | |
| control group (CG) | consisting of healthy pregnant women with uncomplicated pregnancies (n = 48). Receives: Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal serum HbA1c levels for pregnancy-related and postpartum UI
HbA1c levels were significantly associated with an increased severity of incontinence in women with GDM.
Measured: From the time of inclusion in the study until the first postpartum month.
BMI for pregnancy-related and postpartum UI
BMI was a strong predictor of postpartum incontinence persistence in both the type 1 diabetes and GDM groups,
Measured: From the time of inclusion in the study until the first postpartum month.
insulin use for pregnancy-related and postpartum UI
insulin use did not significantly impact UI severity during pregnancy in any of the diabetes subgroups.
Measured: 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
maternal age and history of urinary tract infection were not significantly associated with UI severity or postpartum incontinence in any diabetes group.
Measured: From the time of inclusion in the study until the first postpartum month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start10 Dec 2024
- Primary completion10 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902155
- Sponsor's protocol ID
- Cam ve Sakura Sehir Hastanesi
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37494572Valerio 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.
PubMed 38438778
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diabetes Subtypes on Urinary Incontinence During Pregnancy and Postpartum: A Study on BMI and Glycemic Control
- ClinicalTrials.gov ID
- NCT06902155
- Acronym / sponsor ID
- Cam ve Sakura Sehir Hastanesi
- Conditions
- Urinary Incontinence, Diabetes Mellitus
- Keywords
- Urinary incontinence, pregnancy, diabetes mellitus, Body mass index, glycemic control.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T1DM group | – | Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)type 1 diabetes mellitus group (n = 16) |
| T2DM group | – | Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)type 2 diabetes mellitus group (n = 32) |
| GDM group | – | Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)gestational diabetes mellitus group (n = 51) |
| control group (CG) | – | Diagnostic Test: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)consisting of healthy pregnant women with uncomplicated pregnancies (n = 48). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- multiple pregnancies
- pregnants with chronic kidney disease, and prior urogynecological surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | GDM group, T1DM group, T2DM group, control group (CG) |
Primary outcome
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.
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,
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Results publication: PubMed 37494572Vesentini 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.
- Results publication: PubMed 38438778Valerio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Diabetes Mellitus, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06902155, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.