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

Coloplast

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Other: Axis

Study type: Observational

Funder types: Industry

Identifiers

NCT01541748

CP009SU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

74 participants in 1 patient group

AXIS Allograft Dermis

Description:

Participants receiving AXIS Allograft Dermis for anterior, posterior or combined (anterior and posterior) female pelvic floor repair.

Treatment:

Other: Axis