Uterine ProlapseNCT07295782
The Assessment of Fibrin Clot Phenotype and Thrombin Generation in Women After Urogynecological Surgeries.
An observational study of Uterine Prolapse and Urine Incontinence, run by Jagiellonian University at 1 site in Poland.
Trial summary
Determination of fibrin clot properties along with thrombin generation in women after urigynecological surgery. 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
- Uterine Prolapse, Urine Incontinence
- What is being tested?
- determination of fibrin clot properties
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 10 Dec 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Women with diagnosed uterine prolapse or urine incontinence after failure of pharmacotherapy.
Who may be able to join
- Age 18-70
- treatment failure (pharmacotherapy) due to uterine prolapse or urine incontinence
Who cannot join
- prolonged thromboprophylaxis
- planned surgery other than due to urine incontinence/uterine prolapse
- acquired or congenital thrombophilia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Gynecological Endocrinology Department
Krakow, Małopolska, 31-501
Magdalena MP Piróg, MD, PhD, +48 604514915, magda.m.pulka@gmail.com
About this study
Official title: Fibrin Clot Properties and Thrombin Generation in Women After Urogynecological Surgery.
Determination of fibrin clot properties along with thrombin generation in women after urigynecological surgery.
Read the detailed description
Fibrin clot permeability and susceptibility to lysis along with thrombin generation
- Conditions
- Uterine Prolapse, Urine Incontinence
- Being tested
- determination of fibrin clot properties
- Keywords
- uterine prolapse, urine incontinence, fibrin clot, fibrinolysis, thrombin
- Medical subject headings
- Uterine Prolapse, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determination of fibrin clot propertiesDiagnostic test
Determination of fibre clot properties and thrombin generation in women with uterine prolapse/ urine incontinence before and after urogynecological surgery.
| Study group | Role | What they receive |
|---|---|---|
| Women with urine incontinence/ uterine prolapse | Healthy women with urine incontinence/ uterine prolapse qualified for urogynecological surgery Receives: Diagnostic Test: determination of fibrin clot properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrin clot phenotype
fibrin clot permeability and susceptibility to lysis
Measured: December 2025 till May 2026
Thrombin generation
Endogenous thrombin generation
Measured: December 2025 till May 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ProlapseStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Piróg, MD, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295782
- Sponsor's protocol ID
- 1072.6120.315.2022
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrin Clot Properties and Thrombin Generation in Women After Urogynecological Surgery.
- ClinicalTrials.gov ID
- NCT07295782
- Acronym / sponsor ID
- 1072.6120.315.2022
- Conditions
- Uterine Prolapse, Urine Incontinence
- Keywords
- uterine prolapse, urine incontinence, fibrin clot, fibrinolysis, thrombin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 22 Dec 2025 (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.
Determination of fibrin clot properties along with thrombin generation in women after urigynecological surgery.
Detailed description
Fibrin clot permeability and susceptibility to lysis along with thrombin generation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with urine incontinence/ uterine prolapse | – | Diagnostic Test: determination of fibrin clot propertiesHealthy women with urine incontinence/ uterine prolapse qualified for urogynecological surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with diagnosed uterine prolapse or urine incontinence after failure of pharmacotherapy.
Key inclusion criteria (2 listed)
- Age 18-70
- treatment failure (pharmacotherapy) due to uterine prolapse or urine incontinence
Key exclusion criteria (3 listed)
- prolonged thromboprophylaxis
- planned surgery other than due to urine incontinence/uterine prolapse
- acquired or congenital thrombophilia
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 |
|---|---|---|
| determination of fibrin clot propertiesDetermination of fibre clot properties and thrombin generation in women with uterine prolapse/ urine incontinence before and after urogynecological surgery. | Diagnostic test | Women with urine incontinence/ uterine prolapse |
Primary outcome
fibrin clot phenotype
Time frame: December 2025 till May 2026
fibrin clot permeability and susceptibility to lysis
Thrombin generation
Time frame: December 2025 till May 2026
Endogenous thrombin generation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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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.
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 Uterine Prolapse and Urine Incontinence, run by Jagiellonian University at 1 site in Poland.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdalena MP Piróg, MD, PhD (+48 604514915, magda.m.pulka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fibrin clot phenotype (time frame: December 2025 till May 2026). The study lists 2 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 22 Dec 2025.