Incomplete Uterovaginal Prolapse
Conditions
Interventions
This is a comparative, randomized, controlled, open-label, two-arm clinical trial. Experimental Group: 18 women aged 18-80 years with stage III and IV apical vaginal or vaginal vault prolapse (POP-Q/
A10.850.710.500
Sponsors
Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro
Hospital Municipal Maternidade -Escola Doutor Mário de Moraes Altenfelder Silva
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Women. Age between 18 and 80 years. Report of an uncomfortable bulge in the vaginal area that the patients can feel or see. Pelvic Organ Prolapse grade 3 or higher, anterior, apical, and vault types. The patient or legally authorized representative must agree and provide written informed consent. Be literate. Have accepted the invitation and understood the information contained in the informed consent form. Participant capable and agreeable to follow the established follow-up regimen
Exclusion criteria
Exclusion criteria: Informed consent form. Patients who withdraw from the study. Active or chronic infection, including gynecological infection, urinary tract infection, or local tissue necrosis. History of pelvic organ cancer (uterine, ovarian, bladder, colorectal, or cervical). History of radiotherapy and/or chemotherapy in the pelvic region. Use of systemic steroids in the last month or immunosuppressive or immunomodulatory treatment in the last 3 months. Systemic connective tissue disease (Scleroderma, Systemic Lupus Erythematosus, Marfan Syndrome, Ehlers-Danlos Syndrome, Collagenosis, Polymyositis, Rheumatic Polymyalgia). Neurological disease with neurogenic dysfunction of the lower urinary tract (Multiple Sclerosis, Spinal Cord Injury, or Stroke). Previous prolapse surgery with mesh in the target compartment. Skeletal alteration that prevents positioning in lithotomy. Chronic pelvic pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome: To demonstrate non-inferiority of transvaginal repair with Vivendi (bovine pericardium) versus native tissue repair in improving quality of life, as measured by a reduction in prolapse symptoms; Evaluate the success of transvaginal repair using the Vivendi® graft compared to traditional native tissue repair;Measure patients' perceived improvement | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitor specific side effects related to the use of bovine pericardium, including extrusion, erosion, infection, pain, dyspareunia, and other material-related complications;Evaluate the quality of tissue integration and biointegration of the bovine pericardium graft over time, including the study of chronic inflammatory response and graft compatibility with adjacent tissues | — |
Countries
Brazil
Contacts
Public ContactJosé Ailton Silva
Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro
Outcome results
None listed