Anxiety in Pregnancy (Disorder)NCT04942951
Urinary Incontinence and Anxiety in Pregnancy
An observational study of Anxiety in Pregnancy (Disorder) and Urinary Incontinence, run by Esin Merve Erol Koç at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety in Pregnancy (Disorder), Urinary Incontinence, Quality of Life
- What is being tested?
- Gynecological examination, Pelvic Organ Prolapse Quantification (POP-Q) and Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 5 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Urinary Incontinence on Anxiety Status in Pregnancy Period: A Prospective Case-control Study
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.
Read the 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.
- Being tested
- Gynecological examination, Pelvic Organ Prolapse Quantification (POP-Q), Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire, Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecological examinationDiagnostic 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.
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.
Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaireOther
ICIQ-SF questionnaire was applied to the Study group to determine the severity of urinary incontinence.
Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaireOther
PRAQ-R2 questionnaire was applied to the whole pregnant cohort included in the study to determine their anxiety status.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Gynecological examination; Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification (POP-Q)
graded between 0-4.
Measured: 10 minutes
Secondary outcomes (1)
Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2)
scored between 10-50 points.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start2 Jan 2019
- Primary completion30 Dec 2020
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anxiety in Pregnancy (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esin Merve Erol Koç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esin Merve Erol Koç, Ankara City Hospital Bilkent
- Investigators
- Esin Merve Erol Koç, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942951
- Sponsor's protocol ID
- 0067/2019
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be available if needed by the review board.
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.
PubMed 26584597Huizink 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.
PubMed 25971851Hajebrahimi 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.
PubMed 15183953Felde 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.
PubMed 22068320
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Urinary Incontinence on Anxiety Status in Pregnancy Period: A Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT04942951
- Acronym / sponsor ID
- 0067/2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Esin Merve Erol KoçUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with the diagnosis of urinary incontinence (Study group) | – | 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) questionnaireThe 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) | – | Diagnostic Test: Gynecological examination, Other: Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaireControl 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynecological examinationGynecological 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. | Diagnostic test | Healthy pregnant women (Control group), Pregnant women with the diagnosis of urinary incontinence (Study group) |
| 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 | Pregnant women with the diagnosis of urinary incontinence (Study group) |
| Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaireICIQ-SF questionnaire was applied to the Study group to determine the severity of urinary incontinence. | Other | Pregnant women with the diagnosis of urinary incontinence (Study group) |
| Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnairePRAQ-R2 questionnaire was applied to the whole pregnant cohort included in the study to determine their anxiety status. | Other | Healthy pregnant women (Control group), Pregnant women with the diagnosis of urinary incontinence (Study group) |
Primary outcome
Pelvic Organ Prolapse Quantification (POP-Q)
Time frame: 10 minutes
graded between 0-4.
1 secondary outcome
Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2)
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Results publication: PubMed 26584597Felde 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.
- Results publication: PubMed 25971851Huizink 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.
- Results publication: PubMed 15183953Hajebrahimi 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.
- Results publication: PubMed 22068320Felde 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.
- Individual participant dataSharing planned: No. The data will be available if needed by the review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esin Merve Erol Koç, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety in Pregnancy (Disorder) and Urinary Incontinence, run by Esin Merve Erol Koç at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Organ Prolapse Quantification (POP-Q) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942951, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.