Urinary Incontinence and Anxiety in Pregnancy

NCT04942951 | Completed

• 1 other identifier: 0067/2019
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pelvic Organ Prolapse Quantification (POP-Q)

  graded between 0-4.

  10 minutes

Secondary Outcomes (1)

• Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2)

  20 minutes

Other Outcomes (1)

• Incontinence Consultation Questionnaire-Short Form (ICIQ-SF)

  20 minutes

Study Arms (2)

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; 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.

Diagnostic Test: Gynecological examination; Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire

Interventions

Gynecological examination DIAGNOSTIC_TEST

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.

Healthy pregnant women (Control group); Pregnant women with the diagnosis of urinary incontinence (Study group)

Pelvic Organ Prolapse Quantification (POP-Q) OTHER

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.

Pregnant women with the diagnosis of urinary incontinence (Study group)

Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire OTHER

ICIQ-SF questionnaire was applied to the Study group to determine the severity of urinary incontinence.

Pregnant women with the diagnosis of urinary incontinence (Study group)

Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire OTHER

PRAQ-R2 questionnaire was applied to the whole pregnant cohort included in the study to determine their anxiety status.

Healthy pregnant women (Control group); Pregnant women with the diagnosis of urinary incontinence (Study group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Esin Merve Erol Koç: lead

Study Sites (1)

Esin Merve Erol Koç

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26584597 RESULT

• 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.

  PMID: 25971851 RESULT

• 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.

  PMID: 15183953 RESULT

• 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.

  PMID: 22068320 RESULT

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Gynecological Examination; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Esin Merve Erol Koç, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: January 2, 2019
• Primary Completion: December 30, 2020
• Study Completion: June 5, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)