Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse (NCT03939715) | Clinical Trial Compass
UnknownPhase 4
Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse
United States50 participantsStarted 2020-04-05
Plain-language summary
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
Who can participate
Age range18 Years
SexFEMALE
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:
* Subject is female
* Subject is at least 18 years of age
* Subject has prolapse of the anterior compartment beyond the hymen
* Subject reports bulge symptoms as defined in question 3 of the PFDI-20 with a response of 2 or higher ("somewhat", "moderately" or "quite a bit")
* Subject is willing and able to provide informed consent
* Subject is willing and able to comply with the follow-up protocol through 36 months
Exclusion criteria:
* Subject is pregnant or intends to become pregnant during the study
* Subject has untreated severe urogenital atrophy
* Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
* Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
* Subject has had prior pelvic radiation therapy
* Subject has taken systemic steroids within the last month, or immunosuppressive or immunomodulatory treatment within the last 3 months (list attached)
* Subject has a history of poor wound healing with or without a diagnosis of connective tissue disease
* Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
* Subject has uncontrolled diabetes mellitus (DM) as defined by a hemoglobin A1C \< or = to 8% (Underwood, Ata)
* Subject has a known neurologic or medical condition that may effect of currently affects bladder function
* Subject is seeking obliterative vagi…
What they're measuring
1
Safety through AE and SAE assessments and percentage of incidences
Timeframe: 3 years
2
Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied