Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Coloplast A/S
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
