Urinary Incontinence and Anxiety in Pregnancy

Completed

• Conditions: Anxiety in Pregnancy (Disorder); Urinary Incontinence; Quality of Life
• 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

• Registration Number: NCT04942951
• Lead Sponsor: Esin Merve Erol Koç

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 Timeline

• Study Start: 2019-01-02
• Primary Completion: 2020-12-30
• Status Verified: 2021-06
• Study Completion: 2021-06-05
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women with the diagnosis of urinary incontinence (Study group)	Gynecological examination	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.
Pregnant women with the diagnosis of urinary incontinence (Study group)	Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire	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.
Pregnant women with the diagnosis of urinary incontinence (Study group)	Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire	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 pregnant women (Control group)	Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire	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.
Healthy pregnant women (Control group)	Gynecological 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.
Pregnant women with the diagnosis of urinary incontinence (Study group)	Pelvic Organ Prolapse Quantification (POP-Q)	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.

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse Quantification (POP-Q)	10 minutes	graded between 0-4.

Secondary Outcome Measures

Name	Time	Method
Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2)	20 minutes	scored between 10-50 points.

Trial Locations

Locations (1)

Esin Merve Erol Koç; 🇹🇷 Ankara, Turkey