Urinary Incontinence and Anxiety in Pregnancy

Quality of Life Clinical Trial

Official title:

The Impact of Urinary Incontinence on Anxiety Status in Pregnancy Period: A Prospective Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942951
• Other study ID #: 0067/2019
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: June 5, 2021

Study information

• Verified date: June 2021
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 5, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Enuresis
• Quality of Life
• Urinary Incontinence

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.
• 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.

Locations

Country	Name	City	State
Turkey	Esin Merve Erol Koç	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Esin Merve Erol Koç

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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 i — View Citation

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. — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incontinence Consultation Questionnaire-Short Form (ICIQ-SF)	scored between 1-21 points.	20 minutes
Primary	Pelvic Organ Prolapse Quantification (POP-Q)	graded between 0-4.	10 minutes
Secondary	Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2)	scored between 10-50 points.	20 minutes