This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatment axis
Sponsor Coloplast A/S
Start date November 2011
End date September 2018
Trial size 74 participants
Trial identifier NCT01541748, CP009SU


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Coloplast's Axis™ Allograft Dermis consists of solvent-dehydrated, gamma-irradiated, preserved human collagen. It is restricted to homologus use as a soft tissue graft for horizontal and vertical soft tissue augmentation of thickness and length.

Primary Outcomes

Evaluate efficacy of the Axis Dermis graft used for soft tissue repair, replacement, reconstruction, or augmentations in the correction of POP as assessed by POP-Q Stage improvement
time frame: 1 year

Secondary Outcomes

Assess change in prolapse stage from baseline
time frame: 6 weeks, 6 months, 2 years, 3 years
Patient satisfaction and quality of life measurement
time frame: 6 weeks, 6 months, 2 years, 3 years
Summary of AEs graded as mild, moderate, severe possibly or related to product and/or procedure and SAEs related to product and/or procedure
time frame: 3 years

Eligibility Criteria

Female participants at least 18 years old.

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 midurethral 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.

Additional Information

Official title Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Principal investigator Kristine Whitmore, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Coloplast A/S.