Restorelle Direct Fix A&P Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01378065
First received: June 20, 2011
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.


Condition Intervention
Pelvic Organ Prolapse
Device: Restorelle Direct Fix A&P

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Restorelle Direct Fix A&P Study

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Palpability of the Restorelle Direct Fix A&P [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure rates of de novo dyspareunia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Measure mesh exposure/extrusion after vaginal reconstruction surgery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Determine surgical success rates after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluate patient impression of improvement since treatment via questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Determine bladder function after vaginal reconstruction surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Determine bowel function after vaginal reconstruction surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Determine sexual function after vaginal reconstruction surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Restorelle Direct Fix A&P
    Restorelle Direct Fix A&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic orgains into or out of the vaginal canal.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult female at least 18 years of age
  • Willing and able to provide written informed consent
  • Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as determined by POP-Q requiring surgical intervention in the anterior and/or posterior compartment
  • Willing and able to complete all follow-up visits and procedures indicated in the protocol

Exclusion Criteria:

  • Concurrent surgical treatment of pelvic organ prolapse using anthing other than the Restorelle Direct Fix A&P
  • Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is not being repaired in the same procedure
  • Previous pelvic organ prolapse repair using synthetic grafts
  • Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of vaginal reconstruction
  • Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty) at the time of vaginal reconstruction
  • Pregnant or a desire to become pregnant
  • Previous radiation or other treatments for cancer in the pelvic area
  • Immunosuppression and/or succrent systemic steroid user
  • On any anticoagulation therapy at the time of implant or with bleeding diathesis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378065

Locations
United States, Maryland
MedStar Health Research Institute at Baltimore
Baltimore, Maryland, United States, 21237
United States, Michigan
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Central Missouri Women's Healthcare
Marshall, Missouri, United States, 65340
United States, Tennessee
Center for Pelvic Health
Franklin, Tennessee, United States, 37067
United States, Virginia
The Group for Women
Norfolk, Virginia, United States, 23502
United States, Washington
Integrity Medical Research, LLC
Mountlake Terrace, Washington, United States, 98043
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Barry Jarnagin, MD Center for Pelvic Health, Franklin, TN, United States
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01378065     History of Changes
Other Study ID Numbers: US011
Study First Received: June 20, 2011
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Coloplast A/S:
POP
pelvic organ prolapse
anterior prolapse
posterior prolapse
vaginal prolapse
vaginal floor reconstruction

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014