Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

Phase 4

• Conditions: Pelvic Organ Prolapse

• 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)

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23
• Study Start: 2020-04-05
• Primary Completion: 2022-05-05
• Study Completion: 2022-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Trial Locations

Locations (1)

Colorado Pelvic Floor Consultants; 🇺🇸 Englewood, Colorado, United States