Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

NCT03939715 | Unknown Phase 4 FDA Device

• 1 other identifier: 1385925-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

DermaPure

ACTIVE COMPARATOR

Biological: DermaPure®

Native Tissue

ACTIVE COMPARATOR

Procedure: native tissue

Interventions

DermaPure® BIOLOGICAL

Surgical intervention using DermaPure®

DermaPure

native tissue PROCEDURE

Surgical intervention using native tissue

Native Tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Colorado Pelvic Floor Consultants: lead
• Tissue Regenix Ltd: collaborator

Study Sites (1)

Colorado Pelvic Floor Consultants

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• James Lukban, DO

  Colorado Pelvic Floor Consultants

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CATHERINE JAY

CONTACT

3039558059; cjay@surgone.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 7, 2019
• Study Start: April 5, 2020
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)