Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Coloplast A/S
The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Adult female at least 18 years of age.
Willing and able to provide written informed consent.
Confirmed pelvic organ prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading requiring surgical intervention in the anterior, posterior or combined (anterior and posterior) compartment.
Willing and able to complete all follow-up visits and procedures indicated in this protocol.
You may not be if
Concurrent surgical treatment of pelvic organ prolapse using anything other than the Axis Dermis.\[Note: concurrent mid-urethral sling placement for treatment of stress urinary incontinence is allowed\].
Confirmed Stage 2 or higher prolapse as determined by POP-Q prolapse grading for a compartment that is not being repaired in the same procedure. (Concurrent POP-Q Stage 1 repair is at the physician's discretion.)
Previous pelvic organ prolapse repair using biologic, or synthetic grafts. \[Note: previous mid-urethral sling for treatment of stress urinary incontinence is allowed\]
Pregnant or a desire to become pregnant in the future.
Previous radiation or other treatments for cancer in the pelvic area.
Severe urogenital atrophy.
Immunosuppression and/or current systemic steroid user.
