Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

Status unconfirmed · Phase 4

Conditions studied: Pelvic Organ Prolapse

In brief

Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.

Key facts

Study ID

NCT03939715

Run by

Colorado Pelvic Floor Consultants

People needed

50

Starts

2020-04-05

Expected to finish

2022-05-05

Last updated by the study team

2020-01-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
• Subject is not able to conform to the modified dorsal lithotomy position
• Subject is currently participating in or plans to participate in another pelvic organ prolapse related study during this study
• Subject has had previous prolapse repair with synthetic mesh in the anterior compartment
• Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue or DermaPure®
• Subject is unable to be treated in the anterior compartment with DermaPure®
• Subject is desirous of a concomitant hysteropexy

Where it is running

• Colorado Pelvic Floor Consultants — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.