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
160 participants
OBSERVATIONAL
2019-01-02
2021-06-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
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.
Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire
ICIQ-SF questionnaire was applied to the Study group to determine the severity of urinary incontinence.
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.
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.
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.
Interventions
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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.
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.
Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire
ICIQ-SF questionnaire was applied to the Study group to determine the severity of urinary incontinence.
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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Esin Merve Erol Koç
OTHER
Responsible Party
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Esin Merve Erol Koç
Medical Doctor
Principal Investigators
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Esin Merve Erol Koç, MD
Role: PRINCIPAL_INVESTIGATOR
Ankara City Hospital Bilkent
Locations
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Esin Merve Erol Koç
Ankara, , Turkey (Türkiye)
Countries
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References
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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.
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. doi: 10.1016/j.urology.2004.01.005.
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.
Other Identifiers
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0067/2019
Identifier Type: -
Identifier Source: org_study_id
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