Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

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

Detailed Description
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The investigator is comparing FDA-approved DermaPure with patient's own native tissue for the repair of pelvic organ prolapse. Please see below for detailed objectives and endpoints for our measuring parameters: Objectives Specific Aim #1: To determine the relative safety and efficacy of anterior and multi-compartment vaginal wall prolapse repair augmented with decellularized human dermal allograft (DermaPure®) versus anterior and multi-compartment repair employing native tissue. Specific Aim #2: To evaluate bulge symptoms, quality of life, sexual function, and patient satisfaction Our hypothesis is that pelvic organ prolapse repair augmented with DermaPure® will provide superior anatomic outcomes as compared to native tissue controls with a non-inferior safety profile. Endpoints Safety Endpoint #1: The relative proportion of allograft, native tissue, and procedure-related SAE's at 12 months. Safety Endpoint #2: The relative proportion of allograft, native tissue, and procedure-related AE's of interest at 12 months, which include: Vaginal shortening Vaginal scarring or banding De novo vaginal bleeding Atypical vaginal discharge Fistula formation De novo dyspareunia Pelvic pain Peri-operative infection Vaginal infection UTI Neuromuscular disorder SUI (worsening or de novo) UUI (worsening or de novo) Difficulty emptying bladder (worsening or de novo) Graft exposure (into vagina) Graft erosion (into viscus) Efficacy Endpoint #1: The proportion of patients in each group at 36 months with prolapse of the target compartment beyond the hymen. Efficacy Endpoint #2: The proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by PFDI-20 question number 3 (Does the participant usually have a bulge or something falling out that the participant can see or feel in the vaginal area) answering yes and >= 2 (responses of somewhat, moderately, or quite a bit). (Barber) Efficacy Endpoint #3: The proportion of patients in each group at 36 months requiring re-treatment for recurrent prolapse of the target compartment (to include surgery, physical therapy or pessary insertion). Efficacy Endpoint #4: Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber) Efficacy Endpoint #5: Change in sexual function in each group from baseline to 36 months as measured by the PISQ-IR. (Rogers) Efficacy Endpoint #6: Patient satisfaction in each group at 36 months as measured by the SSQ-8. (Haff) Efficacy Endpoint #7: Patient impression in each group at 36 months of postoperative improvement by the PGI-I (Srikrishna)

Official Title
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Anterior And Multi-Compartment Vaginal Prolapse Repair Augmented With Decellularized Human Dermal Allograft: A Prospactive, Randomized Controlled, Post Market Study

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Biological: DermaPure®
* Procedure: native tissue


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DermaPure<br> | Biological: DermaPure®<br>* Surgical intervention using DermaPure®<br>|
| Active Comparator: Native Tissue<br> | Procedure: native tissue<br>* Surgical intervention using native tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety through AE and SAE assessments and percentage of incidences | The relative proportion of allograft, native tissue, and procedure-related SAE's is assessed at 12 months, 24 months, and 36 months. The relative proportion of allograft, native tissue, and procedure-related AE's of interest is assessed at 12 months, 24 months, and 36 months which include: Vaginal shortening Vaginal scarring or banding De novo vaginal bleeding Atypical vaginal discharge Fistula formation De novo dyspareunia Pelvic pain Peri-operative infection Vaginal infection UTI Neuromuscular disorder SUI (worsening or de novo) UUI (worsening or de novo) Difficulty emptying bladder (worsening or de novo) Graft exposure (into vagina) Graft erosion (into viscus) | 3 years | 
| Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied | The proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by PFDI-20 question number 3 (Do you usually have a bulge or something falling out that you can see or feel in the vaginal area) answering yes and >= 2 (responses of somewhat, moderately, or quite a bit). (Barber) Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber) | 3 years |