Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Pelvic Organ Prolapse (POP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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 organs into or out of the vaginal canal.

Intervention Type DEVICE

Eligibility Criteria

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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 Pelvic Organ Prolapse Quantification System (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 anything 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 current systemic steroid user
* On any anticoagulation therapy at the time of implant or with bleeding diathesis

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No