Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study

Completed

Conditions studied: Pelvic Organ Prolapse

In brief

This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.

Key facts

Study ID

NCT01541748

Run by

Coloplast A/S

People needed

74

Starts

2011-11-01

Expected to finish

2018-11-11

Last updated by the study team

2020-06-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify 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 qualify 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.
• Any contraindication to the surgical procedure.

Where it is running

• Cleveland Clinic Florida — Weston, Florida, United States
• Boston Urogynecology Associates — Cambridge, Massachusetts, United States
• Female Pelvic Medicine and Urogynecology Institute of MI/Grand Rapids Women's Health — Grand Rapids, Michigan, United States
• The Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States
• Philadelphia Urosurgical Associates — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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