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出境医 / 临床实验 / Urinary Incontinence and Anxiety in Pregnancy

Urinary Incontinence and Anxiety in Pregnancy

Study Description
Brief Summary:
This prospective case-control study aimed to evaluate the impact of presence, and severity of urinary incontinence (UI) on pregnancy related anxiety. The study included 160 pregnant women with uncomplicated pregnancies at the second trimester. The pregnant women with UI (n=80) were compared to the control group including continent pregnant women (n=80) in terms of Pregnancy-Related Anxiety Scores (PRAQ-R2) and Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) in pregnant women. Pelvic Organ Prolapse Questionnaire (POP-Q) was considered for the diagnosis of pelvic organ prolapsus. The UI was also divided into subgroups as stress (SUI), urge (UUI), and mixed (MUI) types and they were also compared to the control group.

Condition or disease Intervention/treatment
Anxiety in Pregnancy (Disorder) Urinary Incontinence Quality of Life Diagnostic Test: Gynecological examination Other: Pelvic Organ Prolapse Quantification (POP-Q) Other: Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire

Detailed Description:

In this study, we aimed to evaluate the impact of the presence and the severity of UI on pregnancy related anxiety status in a well-defined pregnant cohort. The correlations were also analyzed in terms of the UI subtypes as stress urinary incontinence (SUI), urge urinary incontinence (UUI) and mixed urinary incontinence (MUI). A total of 160 pregnant women applied to outpatient clinics of Obstetrics and Urology Departments were included in the current study. Patients were compared in two groups in terms of Study group including pregnant women who were diagnosed with the UI (n=80) and Control group including healthy pregnant women (n=80). The study was approved by the institutional review board of Ankara Training and Research Hospital (# 0067/2019). All the participants were informed, and written consent was obtained before the participated the study.

Physical examination was performed to diagnose the pelvic organ prolapse and the findings were classified through the five categories based on Pelvic Organ Prolapse Quantification (POP-Q). According to POP-Q, only the pregnant women diagnosed with category 0 or category 1 were included in the study. All the pregnant women included in the current study were married and multiparous women, at the second trimester of the pregnancy, with uncomplicated pregnancies and regular pregnancy follow-up. Pregnancies complicated by chronic maternal diseases (rheumatological diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, hypo-hyperthyroidy, congenital hematological disorders), acute inflammatory conditions (acute pancreatitis, acute appendicitis), pregnancy complications (gestational diabetes, preeclampsia, preterm labor, preterm premature rupture of membranes), history of alcohol consumption, having multiple pregnancies, psychiatric diseases, cognitive disorders, neurogenic bladder, fecal incontinence, chronic constipation, chronic cough, urinary infection, history of pelvic surgery including incontinence surgeries and/or taking medication for UI were excluded from the current study. Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) scale was used to evaluate the anxiety status of the participants. The International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) which has been defined by Hajebrahimi et al. as a reliable scale, and validated in Turkish by Demircan et al. was used for the evaluation of UI. This scale includes questions about the frequency of UI, the conditions at which UI occurs and how much it affects the social life of the person. UI subtypes were diagnosed according to the definitions of the International Continence Society.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Impact of Urinary Incontinence on Anxiety Status in Pregnancy Period: A Prospective Case-control Study
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : June 5, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Pregnant women with the diagnosis of urinary incontinence (Study group)
The pregnant women who were diagnosed with the urinary incontinence (n=80) with category 0 or category 1 Pelvic Organ Prolapse Quantification (POP-Q) score in physical examination.
Diagnostic Test: Gynecological examination
Gynecological examination was performed to the whole pregnant cohort included in the study to diagnose either the pelvic organ prolapse according to the POP-Q system or to be sure that they have no findings of pelvic organ prolapse.

Other: Pelvic Organ Prolapse Quantification (POP-Q)
Gynecological examination was performed to the whole pregnant cohort included in the study to diagnose either the pelvic organ prolapse according to the POP-Q system or to be sure that they have no findings of pelvic organ prolapse.

Other: Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire
ICIQ-SF questionnaire was applied to the Study group to determine the severity of urinary incontinence.

Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire
PRAQ-R2 questionnaire was applied to the whole pregnant cohort included in the study to determine their anxiety status.

Healthy pregnant women (Control group)
Control group consisted of healthy women with uncomplicated pregnancies (n=80). They had no complaint of urinary incontinence and their gynecological examination did not reveal any finding of pelvic organ prolapse.
Diagnostic Test: Gynecological examination
Gynecological examination was performed to the whole pregnant cohort included in the study to diagnose either the pelvic organ prolapse according to the POP-Q system or to be sure that they have no findings of pelvic organ prolapse.

Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire
PRAQ-R2 questionnaire was applied to the whole pregnant cohort included in the study to determine their anxiety status.

Outcome Measures
Primary Outcome Measures :
  1. Pelvic Organ Prolapse Quantification (POP-Q) [ Time Frame: 10 minutes ]
    graded between 0-4.


Secondary Outcome Measures :
  1. Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) [ Time Frame: 20 minutes ]
    scored between 10-50 points.


Other Outcome Measures:
  1. Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) [ Time Frame: 20 minutes ]
    scored between 1-21 points.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Study group: The pregnant women who were diagnosed with the urinary incontinence (n=80) with category 0 or category 1 Pelvic Organ Prolapse Quantification (POP-Q) score in physical examination.

Control group: Consisted of healthy women with uncomplicated pregnancies (n=80). They had no complaint of urinary incontinence and their gynecological examination did not reveal any finding of pelvic organ prolapse.

The pregnant women included both in the Study and Control group were married and multiparous women, at the second trimester of the pregnancy, with uncomplicated pregnancies and regular pregnancy follow-up.

Criteria

Inclusion Criteria:

The pregnant women who were diagnosed with the urinary incontinence (n=80) with category 0 or category 1 Pelvic Organ Prolapse Quantification (POP-Q) score in physical examination.

Healthy women with uncomplicated pregnancies (n=80) with no complaint or finding of urinary incontinence.

Married and multiparous women, at the second trimester of the pregnancy, with uncomplicated pregnancies and regular pregnancy follow-up.

Exclusion Criteria:

Pregnancies complicated by chronic maternal diseases, acute inflammatory conditions, pregnancy complications, history of alcohol consumption, having multiple pregnancies, psychiatric diseases, cognitive disorders, neurogenic bladder, fecal incontinence, chronic constipation, chronic cough, urinary infection, history of pelvic surgery including incontinence surgeries and/or taking medication for urinary incontinence were excluded.

Contacts and Locations

Locations
Layout table for location information
Turkey
Esin Merve Erol Koç
Ankara, Turkey, 06800
Sponsors and Collaborators
Esin Merve Erol Koç
Investigators
Layout table for investigator information
Principal Investigator: Esin Merve Erol Koç, MD Ankara City Hospital Bilkent
Tracking Information
First Submitted Date June 21, 2021
First Posted Date June 29, 2021
Last Update Posted Date June 29, 2021
Actual Study Start Date January 2, 2019
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2021)
Pelvic Organ Prolapse Quantification (POP-Q) [ Time Frame: 10 minutes ]
graded between 0-4.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 21, 2021)
Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) [ Time Frame: 20 minutes ]
scored between 10-50 points.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2021)
Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) [ Time Frame: 20 minutes ]
scored between 1-21 points.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Urinary Incontinence and Anxiety in Pregnancy
Official Title The Impact of Urinary Incontinence on Anxiety Status in Pregnancy Period: A Prospective Case-control Study
Brief Summary This prospective case-control study aimed to evaluate the impact of presence, and severity of urinary incontinence (UI) on pregnancy related anxiety. The study included 160 pregnant women with uncomplicated pregnancies at the second trimester. The pregnant women with UI (n=80) were compared to the control group including continent pregnant women (n=80) in terms of Pregnancy-Related Anxiety Scores (PRAQ-R2) and Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) in pregnant women. Pelvic Organ Prolapse Questionnaire (POP-Q) was considered for the diagnosis of pelvic organ prolapsus. The UI was also divided into subgroups as stress (SUI), urge (UUI), and mixed (MUI) types and they were also compared to the control group.
Detailed Description

In this study, we aimed to evaluate the impact of the presence and the severity of UI on pregnancy related anxiety status in a well-defined pregnant cohort. The correlations were also analyzed in terms of the UI subtypes as stress urinary incontinence (SUI), urge urinary incontinence (UUI) and mixed urinary incontinence (MUI). A total of 160 pregnant women applied to outpatient clinics of Obstetrics and Urology Departments were included in the current study. Patients were compared in two groups in terms of Study group including pregnant women who were diagnosed with the UI (n=80) and Control group including healthy pregnant women (n=80). The study was approved by the institutional review board of Ankara Training and Research Hospital (# 0067/2019). All the participants were informed, and written consent was obtained before the participated the study.

Physical examination was performed to diagnose the pelvic organ prolapse and the findings were classified through the five categories based on Pelvic Organ Prolapse Quantification (POP-Q). According to POP-Q, only the pregnant women diagnosed with category 0 or category 1 were included in the study. All the pregnant women included in the current study were married and multiparous women, at the second trimester of the pregnancy, with uncomplicated pregnancies and regular pregnancy follow-up. Pregnancies complicated by chronic maternal diseases (rheumatological diseases, renal failure, vascular malformations, hypertension, cardiac disease, diabetes mellitus, obesity, hypo-hyperthyroidy, congenital hematological disorders), acute inflammatory conditions (acute pancreatitis, acute appendicitis), pregnancy complications (gestational diabetes, preeclampsia, preterm labor, preterm premature rupture of membranes), history of alcohol consumption, having multiple pregnancies, psychiatric diseases, cognitive disorders, neurogenic bladder, fecal incontinence, chronic constipation, chronic cough, urinary infection, history of pelvic surgery including incontinence surgeries and/or taking medication for UI were excluded from the current study. Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) scale was used to evaluate the anxiety status of the participants. The International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) which has been defined by Hajebrahimi et al. as a reliable scale, and validated in Turkish by Demircan et al. was used for the evaluation of UI. This scale includes questions about the frequency of UI, the conditions at which UI occurs and how much it affects the social life of the person. UI subtypes were diagnosed according to the definitions of the International Continence Society.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

Study group: The pregnant women who were diagnosed with the urinary incontinence (n=80) with category 0 or category 1 Pelvic Organ Prolapse Quantification (POP-Q) score in physical examination.

Control group: Consisted of healthy women with uncomplicated pregnancies (n=80). They had no complaint of urinary incontinence and their gynecological examination did not reveal any finding of pelvic organ prolapse.

The pregnant women included both in the Study and Control group were married and multiparous women, at the second trimester of the pregnancy, with uncomplicated pregnancies and regular pregnancy follow-up.

Condition
  • Anxiety in Pregnancy (Disorder)
  • Urinary Incontinence
  • Quality of Life
Intervention
  • Diagnostic Test: Gynecological examination
    Gynecological examination was performed to the whole pregnant cohort included in the study to diagnose either the pelvic organ prolapse according to the POP-Q system or to be sure that they have no findings of pelvic organ prolapse.
  • Other: Pelvic Organ Prolapse Quantification (POP-Q)
    Gynecological examination was performed to the whole pregnant cohort included in the study to diagnose either the pelvic organ prolapse according to the POP-Q system or to be sure that they have no findings of pelvic organ prolapse.
  • Other: Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire
    ICIQ-SF questionnaire was applied to the Study group to determine the severity of urinary incontinence.
  • Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire
    PRAQ-R2 questionnaire was applied to the whole pregnant cohort included in the study to determine their anxiety status.
Study Groups/Cohorts
  • Pregnant women with the diagnosis of urinary incontinence (Study group)
    The pregnant women who were diagnosed with the urinary incontinence (n=80) with category 0 or category 1 Pelvic Organ Prolapse Quantification (POP-Q) score in physical examination.
    Interventions:
    • Diagnostic Test: Gynecological examination
    • Other: Pelvic Organ Prolapse Quantification (POP-Q)
    • Other: Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire
    • Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire
  • Healthy pregnant women (Control group)
    Control group consisted of healthy women with uncomplicated pregnancies (n=80). They had no complaint of urinary incontinence and their gynecological examination did not reveal any finding of pelvic organ prolapse.
    Interventions:
    • Diagnostic Test: Gynecological examination
    • Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire
Publications *
  • Felde G, Ebbesen MH, Hunskaar S. Anxiety and depression associated with urinary incontinence. A 10-year follow-up study from the Norwegian HUNT study (EPINCONT). Neurourol Urodyn. 2017 Feb;36(2):322-328. doi: 10.1002/nau.22921. Epub 2015 Nov 20. Erratum in: Neurourol Urodyn. 2020 Feb;39(2):871-872.
  • Huizink AC, Delforterie MJ, Scheinin NM, Tolvanen M, Karlsson L, Karlsson H. Adaption of pregnancy anxiety questionnaire-revised for all pregnant women regardless of parity: PRAQ-R2. Arch Womens Ment Health. 2016 Feb;19(1):125-32. doi: 10.1007/s00737-015-0531-2. Epub 2015 May 14.
  • Hajebrahimi S, Corcos J, Lemieux MC. International consultation on incontinence questionnaire short form: comparison of physician versus patient completion and immediate and delayed self-administration. Urology. 2004 Jun;63(6):1076-8.
  • Felde G, Bjelland I, Hunskaar S. Anxiety and depression associated with incontinence in middle-aged women: a large Norwegian cross-sectional study. Int Urogynecol J. 2012 Mar;23(3):299-306. doi: 10.1007/s00192-011-1564-3. Epub 2011 Nov 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 21, 2021)
160
Original Actual Enrollment Same as current
Actual Study Completion Date June 5, 2021
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

The pregnant women who were diagnosed with the urinary incontinence (n=80) with category 0 or category 1 Pelvic Organ Prolapse Quantification (POP-Q) score in physical examination.

Healthy women with uncomplicated pregnancies (n=80) with no complaint or finding of urinary incontinence.

Married and multiparous women, at the second trimester of the pregnancy, with uncomplicated pregnancies and regular pregnancy follow-up.

Exclusion Criteria:

Pregnancies complicated by chronic maternal diseases, acute inflammatory conditions, pregnancy complications, history of alcohol consumption, having multiple pregnancies, psychiatric diseases, cognitive disorders, neurogenic bladder, fecal incontinence, chronic constipation, chronic cough, urinary infection, history of pelvic surgery including incontinence surgeries and/or taking medication for urinary incontinence were excluded.

Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04942951
Other Study ID Numbers 0067/2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The data will be available if needed by the review board.
Responsible Party Esin Merve Erol Koç, Ankara City Hospital Bilkent
Study Sponsor Esin Merve Erol Koç
Collaborators Not Provided
Investigators
Principal Investigator: Esin Merve Erol Koç, MD Ankara City Hospital Bilkent
PRS Account Ankara City Hospital Bilkent
Verification Date June 2021