Pelvic Organ Prolapse Clinical Trial
Official title:
Anterior And Multi-Compartment Vaginal Prolapse Repair Augmented With Decellularized Human Dermal Allograft: A Prospactive, Randomized Controlled, Post Market Study
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
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)
;
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