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 range
18 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:
* 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…
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
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