The Assessment of Fibrin Clot Phenotype and Thrombin Generation in Women After Urogynecological Surgeries.

NCT07295782 | Recruiting DMC

• 1 other identifier: 1072.6120.315.2022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Determination of fibrin clot properties along with thrombin generation in women after urigynecological surgery.

Conditions

Uterine Prolapse; Urine Incontinence

Keywords

uterine prolapse; urine incontinence; fibrin clot; fibrinolysis; thrombin

Outcome Measures

Primary Outcomes (2)

• fibrin clot phenotype

  fibrin clot permeability and susceptibility to lysis

  December 2025 till May 2026

• Thrombin generation

  Endogenous thrombin generation

  December 2025 till May 2026

Study Arms (1)

Women with urine incontinence/ uterine prolapse

Healthy women with urine incontinence/ uterine prolapse qualified for urogynecological surgery

Diagnostic Test: determination of fibrin clot properties

Interventions

determination of fibrin clot properties DIAGNOSTIC_TEST

Determination of fibre clot properties and thrombin generation in women with uterine prolapse/ urine incontinence before and after urogynecological surgery.

Women with urine incontinence/ uterine prolapse

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Participants with urine incontinence and uterine prolapse will be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with diagnosed uterine prolapse or urine incontinence after failure of pharmacotherapy.

You may qualify if:

• Age 18-70
• treatment failure (pharmacotherapy) due to uterine prolapse or urine incontinence

You may not qualify if:

• prolonged thromboprophylaxis
• planned surgery other than due to urine incontinence/uterine prolapse
• acquired or congenital thrombophilia

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Gynecological Endocrinology Department

Krakow, Małopolska, 31-501, Poland

RECRUITING

MeSH Terms

Conditions

Uterine Prolapse; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Enuresis; Urination Disorders; Urologic Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Central Study Contacts

Magdalena MP Piróg, MD, PhD

CONTACT

+48 604514915; magda.m.pulka@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

PL (1)