Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Biological: DermaPure®Procedure: native tissue
- Registration Number
- NCT03939715
- Lead Sponsor
- Colorado Pelvic Floor Consultants
- 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DermaPure DermaPure® - Native Tissue native tissue -
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Colorado Pelvic Floor Consultants
🇺🇸Englewood, Colorado, United States