Pelvic Congestion SyndromeNCT05889000
Quality of Life Questionnaire and Disease Severity Scale
An observational study of Pelvic Congestion Syndrome, run by Kazan State Medical University at 1 site in Russia.
Trial summary
There are currently no specific validated patient-centric tools for the clinical evaluation of patients with chronic pelvic venous disorders (CPVD). The study involves the development and validation of a questionnaire for the quality of life and a scale of disease severity for a patient with pelvic venous disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Congestion Syndrome
- What is being tested?
- questionnaire responses
- How many people
- 397 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2018to 10 Jan 2022
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients attending primary care
Who may be able to join
- presence of PVV;
- completed Patient Informed Consent Form;
- age from 18 to 70 years;
- ability to understand and answer the questions of the proposed questionnaire.
Who cannot join
- absence of confirmed PVV;
- lack of Patient Informed Consent Form;
- under the age of 18 or over 70 years old;
- pregnancy at any stage and 12-month postpartum period;
- presence of a gynecological or other concomitant (urological, neurological, procto-logical, etc.) significant pathology that has similar clinical symptoms with CPVD and re-quires specific treatment;
- presence of severe concomitant gastrointestinal or hematopoietic system pathology, terminal stages of cardiovascular, respiratory, renal and hepatic failure, stage IV malignant tumor, obliterating diseases of lower limbs arteries;
- dementia and other mental disorders that limit the ability to understand the essence of the research, fill out Patient Informed Consent Form and answer the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life Questionnaire and Disease Severity Scale for Patients With Chronic Pelvic Venous Disorders: Design and Validation
There are currently no specific validated patient-centric tools for the clinical evaluation of patients with chronic pelvic venous disorders (CPVD). The study involves the development and validation of a questionnaire for the quality of life and a scale of disease severity for a patient with pelvic venous disease.
Read the detailed description
This retrospective study will include patients with pelvic varicose veins seen between 2018 and 2020.
2 groups of patients will be formed. The main group will be women with verified CPVD, the comparison group - 93 participants without signs of CPVD.
All patients will respond to the previously developed Pelvic Varicose Veins Questionnaire (PVVQ) and Pelvic Venous Clinical Severity Score (PVCSS) as submitted questionnaires.
Validation of the PVVQ questionnaire and the PVCSS scale will be carried out in accordance with the methodology for studying the quality of life and clinical scales in accordance with international standards. The main psychometric properties of both instruments in terms of validity, reliability and sensitivity will be assessed.
The validation protocol will include certain steps: 1) pre-testing, 2) assessing the reliability of the questionnaire, 3) assessing the validity, 4) assessing the sensitivity.
- Preliminary testing. For preliminary testing, patients will fill out questionnaires, followed by finding out how clear the questions asked are, how accurate and ethical the formulations are, in their opinion. The convenience of working with the questionnaire from the point of view of the research doctor will also be assessed.
- Reliability assessment. The reliability assessment will be carried out according to three criteria - internal consistency, discriminant validity and internal consistency. To assess the degree of internal consistency, the Cronbach's alpha coefficient will be used, which is calculated by the formula: α = N * r / (1 + r * (N - 1)), where N is the number of components under study, r is the average correlation coefficient between the components. The study will assess the reliability of the questionnaire and the scale as a whole, as well as the impact on the overall reliability of each individual domain. Domain correlation will be assessed using Spearman's rank correlation method (r). To assess discriminant validity, the level of quality of life and disease severity of patients with VBT will be compared with similar levels of healthy participants. Assessment of internal consistency will be performed by retesting stable patients without treatment after 14 days, followed by calculation of Cronbach's alpha.
- Assessment of validity. To assess the validity, the reliability of the construct will be studied by determining the criterion validity, i.e. identifying the correlation coefficient or relationships between the scales of both questionnaires with some external criterion. The scales of the SF-36 questionnaire will be used as external criteria for assessing the quality of life, and elements of visual analogue scales will be used to assess the severity of the disease. To study the degree of representation of the studied psychological construct in the test results, both types of construct validity will be determined: convergent and discriminant.
- Sensitivity assessment. To assess the sensitivity, a comparison of the indicators of the questionnaire questionnaires at the points before treatment and 2 months after the treatment will be carried out.
Based on this examination of the data, objective information on the validity, reliability and sensitivity of PVVQ and PVCSS will be obtained.
- Conditions
- Pelvic Congestion Syndrome
- Being tested
- questionnaire responses
- Keywords
- quality of life questionnaire, chronic pelvic venous disorders, Pelvic Varicose Veins Questionnaire, pelvic congestion syndrome, validation, Pelvi Venous Clinical Severity Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire responsesOther
questionnaire responses - Pelvic Varicose Veins Questionnaire (PVVQ) and Pelvic Venous Clinical Severity Score (PVCSS)
| Study group | Role | What they receive |
|---|---|---|
| main group | 304 patients with verified CPVD Receives: Other: questionnaire responses | |
| comparison group | 93 participants without signs of CPVD. Receives: Other: questionnaire responses |
What is being measured
The primary outcome is the main question the study is designed to answer.
internal consistency assessment
To assess the degree of internal consistency, the Cronbach's alpha coefficient will be used, which is calculated by the formula: α = N * r / (1 + r * (N - 1)), where N is the number of components under study, r is the average correlation coefficient between the components. The study will assess the reliability of the questionnaire and the scale as a whole, as well as the impact on the overall reliability of each individual domain. Domain correlation will be assessed using Spearman's rank correlation method (r).
Measured: At baseline
discriminant validity evaluation internal consistency score
To assess discriminant validity, the level of quality of life and disease severity of patients with CPVD will be compared with similar levels of healthy participants.
Measured: At baseline
internal consistency score
Assessment of internal consistency will be performed by retesting stable patients without treatment after 14 days, followed by calculation of Cronbach's alpha.
Measured: At baseline and after 14 days
determination of criterion validity
To assess the validity, the reliability of the construct will be studied by determining the criterion validity, i.e. identifying the correlation coefficient or relationships between the scales of both questionnaires with some external criterion. The scales of the SF-36 questionnaire will be used as external criteria for assessing the quality of life, and elements of visual analogue scales will be used to assess the severity of the disease.
Measured: At baseline
Sensitivity assessment.
To assess the sensitivity, a comparison of the indicators of the questionnaire questionnaires at the points before treatment and 2 months after the treatment will be carried out.
Measured: At baseline and after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start10 Jan 2018
- Primary completion31 Dec 2020
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestion SyndromeStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazan State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Interregional Clinical Diagnostic Center, Russia
- Responsible party
- Principal investigator, Rustem V. Akhmetzyanov, MD, PhD., Kazan State Medical University
- Investigators
- Aigul A Mutygullina, PhD, Study director, Kazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889000
- Sponsor's protocol ID
- 10012022
- Status last verified
- May 2023
- First submitted
- 24 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Questionnaire and Disease Severity Scale for Patients With Chronic Pelvic Venous Disorders: Design and Validation
- ClinicalTrials.gov ID
- NCT05889000
- Acronym / sponsor ID
- 10012022
- Conditions
- Pelvic Congestion Syndrome
- Keywords
- quality of life questionnaire, chronic pelvic venous disorders, Pelvic Varicose Veins Questionnaire, pelvic congestion syndrome, validation, Pelvi Venous Clinical Severity Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Kazan State Medical UniversityUniversity, hospital or other
- Collaborators
- Interregional Clinical Diagnostic Center, Russia
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 5 Jun 2023 (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.
There are currently no specific validated patient-centric tools for the clinical evaluation of patients with chronic pelvic venous disorders (CPVD). The study involves the development and validation of a questionnaire for the quality of life and a scale of disease severity for a patient with pelvic venous disease.
Detailed description
This retrospective study will include patients with pelvic varicose veins seen between 2018 and 2020.
2 groups of patients will be formed. The main group will be women with verified CPVD, the comparison group - 93 participants without signs of CPVD.
All patients will respond to the previously developed Pelvic Varicose Veins Questionnaire (PVVQ) and Pelvic Venous Clinical Severity Score (PVCSS) as submitted questionnaires.
Validation of the PVVQ questionnaire and the PVCSS scale will be carried out in accordance with the methodology for studying the quality of life and clinical scales in accordance with international standards. The main psychometric properties of both instruments in terms of validity, reliability and sensitivity will be assessed.
The validation protocol will include certain steps: 1) pre-testing, 2) assessing the reliability of the questionnaire, 3) assessing the validity, 4) assessing the sensitivity.
- Preliminary testing. For preliminary testing, patients will fill out questionnaires, followed by finding out how clear the questions asked are, how accurate and ethical the formulations are, in their opinion. The convenience of working with the questionnaire from the point of view of the research doctor will also be assessed.
- Reliability assessment. The reliability assessment will be carried out according to three criteria - internal consistency, discriminant validity and internal consistency. To assess the degree of internal consistency, the Cronbach's alpha coefficient will be used, which is calculated by the formula: α = N * r / (1 + r * (N - 1)), where N is the number of components under study, r is the average correlation coefficient between the components. The study will assess the reliability of the questionnaire and the scale as a whole, as well as the impact on the overall reliability of each individual domain. Domain correlation will be assessed using Spearman's rank correlation method (r). To assess discriminant validity, the level of quality of life and disease severity of patients with VBT will be compared with similar levels of healthy participants. Assessment of internal consistency will be performed by retesting stable patients without treatment after 14 days, followed by calculation of Cronbach's alpha.
- Assessment of validity. To assess the validity, the reliability of the construct will be studied by determining the criterion validity, i.e. identifying the correlation coefficient or relationships between the scales of both questionnaires with some external criterion. The scales of the SF-36 questionnaire will be used as external criteria for assessing the quality of life, and elements of visual analogue scales will be used to assess the severity of the disease. To study the degree of representation of the studied psychological construct in the test results, both types of construct validity will be determined: convergent and discriminant.
- Sensitivity assessment. To assess the sensitivity, a comparison of the indicators of the questionnaire questionnaires at the points before treatment and 2 months after the treatment will be carried out.
Based on this examination of the data, objective information on the validity, reliability and sensitivity of PVVQ and PVCSS will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| main group | – | Other: questionnaire responses304 patients with verified CPVD |
| comparison group | – | Other: questionnaire responses93 participants without signs of CPVD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients attending primary care
Key inclusion criteria (4 listed)
- presence of PVV;
- completed Patient Informed Consent Form;
- age from 18 to 70 years;
- ability to understand and answer the questions of the proposed questionnaire.
Key exclusion criteria (7 listed)
- absence of confirmed PVV;
- lack of Patient Informed Consent Form;
- under the age of 18 or over 70 years old;
- pregnancy at any stage and 12-month postpartum period;
- presence of a gynecological or other concomitant (urological, neurological, procto-logical, etc.) significant pathology that has similar clinical symptoms with CPVD and re-quires specific treatment;
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 |
|---|---|---|
| questionnaire responsesquestionnaire responses - Pelvic Varicose Veins Questionnaire (PVVQ) and Pelvic Venous Clinical Severity Score (PVCSS) | Other | comparison group, main group |
Primary outcome
internal consistency assessment
Time frame: At baseline
To assess the degree of internal consistency, the Cronbach's alpha coefficient will be used, which is calculated by the formula: α = N * r / (1 + r * (N - 1)), where N is the number of components under study, r is the average correlation coefficient between the components. The study will assess the reliability of the questionnaire and the scale as a whole, as well as the impact on the overall reliability of each individual domain. Domain correlation will be assessed using Spearman's rank correlation method (r).
discriminant validity evaluation internal consistency score
Time frame: At baseline
To assess discriminant validity, the level of quality of life and disease severity of patients with CPVD will be compared with similar levels of healthy participants.
internal consistency score
Time frame: At baseline and after 14 days
Assessment of internal consistency will be performed by retesting stable patients without treatment after 14 days, followed by calculation of Cronbach's alpha.
determination of criterion validity
Time frame: At baseline
To assess the validity, the reliability of the construct will be studied by determining the criterion validity, i.e. identifying the correlation coefficient or relationships between the scales of both questionnaires with some external criterion. The scales of the SF-36 questionnaire will be used as external criteria for assessing the quality of life, and elements of visual analogue scales will be used to assess the severity of the disease.
Sensitivity assessment.
Time frame: At baseline and after 2 months
To assess the sensitivity, a comparison of the indicators of the questionnaire questionnaires at the points before treatment and 2 months after the treatment will be carried out.
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 5 Jun 2023.
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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.
Aigul A Mutygullina, PhD study director
Kazan State Medical University
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 Pelvic Congestion Syndrome, run by Kazan State Medical University at 1 site in Russia.
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 4 inclusion and 7 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 5 Jun 2023. 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 Russia. 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?
internal consistency assessment (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.