Pelvic Organ Prolapse
Conditions
Brief summary
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
Detailed description
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)
Interventions
BIOLOGICALDermaPure®
Surgical intervention using DermaPure®
PROCEDUREnative tissue
Surgical intervention using native tissue
Sponsors
Tissue Regenix Ltd
Colorado Pelvic Floor Consultants
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety through AE and SAE assessments and percentage of incidences | 3 years | 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) |
| Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied | 3 years | 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) |
Countries
United States
Contacts
Primary ContactCATHERINE JAY
Outcome results
None listed