Restorelle Direct Fix A&P Study
This study is ongoing, but not recruiting participants.
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01378065
First received: June 20, 2011
Last updated: February 6, 2013
Last verified: February 2013
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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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 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
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 Jarnigan, 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: | February 6, 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 May 16, 2013