CompletedNot Applicable

Quality of Life Questionnaire and Disease Severity Scale

Russia397 participantsStarted 2018-01-10

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

internal consistency assessment

Timeframe: At baseline

discriminant validity evaluation internal consistency score

Timeframe: At baseline

internal consistency score

Timeframe: At baseline and after 14 days

determination of criterion validity

Timeframe: At baseline

Sensitivity assessment.

Timeframe: At baseline and after 2 months

Trial details

NCT IDNCT05889000

SponsorKazan State Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Pelvic Congestion Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

internal consistency assessment

Timeframe: At baseline

discriminant validity evaluation internal consistency score

Timeframe: At baseline

internal consistency score

Timeframe: At baseline and after 14 days

determination of criterion validity

Timeframe: At baseline

Sensitivity assessment.

Timeframe: At baseline and after 2 months