xenform postmarket surveillance study

Conditions: Pelvic Organ Prolapse

Summary: to compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

the primary objective is to evaluate clinical effectiveness of transvaginal repair with xenform against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. secondary objectives are to evaluate xenform-related complications and subject reported outcomes. the primary endpoint of the study is to achieve non-inferiority of transvaginal repair with xenform over native tissue repair at 36 months as compared to baseline. success will be based on a composite of objective and subjective measures. additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with xenform to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point. the secondary endpoints of the study include assessments of complications and subject reported outcomes.

Eligibility criteria:
inclusion criteria: * subject is female * subject is at least 18 years of age * subject has pelvic organ prolapse with the leading edge at or beyond the hymen. at or beyond the hymen is defined as pop-q scores of ba≥0 (for prolapse of the anterior compartment alone) or c≥0 (for prolapse of the apical compartment alone) or c≥-1/2 tvl and ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments). * subject reports a bothersome bulge they can see or feel per pfdi-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit") * subject or subject's legally authorized representative is willing to provide written informed consent * subject is willing and able to comply with the follow-up regimen exclusion criteria: * subject is pregnant or intends to become pregnant during the study * subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (uti) or tissue necrosis * subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical) * subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area * subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months) * subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (sle), marfan syndrome, ehlers danlos, collagenosis, polymyositis, polymyalgia rheumatica) * subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis * subject has uncontrolled diabetes mellitus (dm) * subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit) * 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 device or drug study during this study * subject has a known sensitivity to any xenform component * subject has had previous prolapse repair with mesh in the target compartment * subject is planning to undergo a concomitant prolapse repair with use of mesh in the non-target compartment

Keywords: pop transvaginal native tissue repair repair augmented with mesh biologic graft pelvic organ prolapse