About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse

Clinicaltrials.gov identifier NCT03939715

Recruitment Status Not yet recruiting

First Posted May 7, 2019

Last update posted January 23, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Pelvic Organ Prolapse
  • Intervention/Treatment: Biological: DermaPure®
    Procedure: native tissue
  • Phase: Phase 4
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Anterior And Multi-Compartment Vaginal Prolapse Repair Augmented With Decellularized Human Dermal Allograft: A Prospactive, Randomized Controlled, Post Market Study
  • Estimated Study Start Date: April 2020
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: May 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: DermaPure
Biological: DermaPure®
Surgical intervention using DermaPure®
Active Comparator: Native Tissue
Procedure: native tissue
Surgical intervention using native tissue
Outcome Measures
  • Primary Outcome Measures: 1. Safety through AE and SAE assessments and percentage of incidences [ Time Frame: 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)
  • 2. Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied [ Time Frame: 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)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: CATHERINE JAY 3039558059 cjay@surgone.com

Locations

United States, Colorado
Colorado Pelvic Floor Consultants
Englewood

Sponsors and Collaborators

Colorado Pelvic Floor Consultants

Tissue Regenix Ltd

Investigators

Principal Investigator: James Lukban, DO Colorado Pelvic Floor Consultants

More Information
  • Responsible Party: Colorado Pelvic Floor Consultants
  • ClinicalTrials.gov Identifier: NCT03939715 History of Changes
  • Other Study ID Numbers: 1385925-1
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: January 23, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Supporting Materials: Study Protocol, Informed Consent Form (ICF)
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Prolapse Pelvic Organ Prolapse