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

NCT01541748 | Completed Results

• 1 other identifier: CP009SU
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and One Year.

  The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are: Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1 centimeter below the plan of the hymen but protrudes no further than 2 centimeters less that the total vaginal length in centimeters Stage 4: The distal portion of the prolapse protrudes to at least (TVL-2) centimeters. Improvement at one year is categorized as follows: Cured: Pop-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline Improved: POP-Q Stage \> 1, but improved by 1 stage from baseline Failed: POP-Q Stage stayed the same or increased in severity from baseline

  1 year

Secondary Outcomes (17)

• Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and Six Weeks

  6 weeks

• Percentage of Participants With POP-Q Stage Improvement After POP Repair With Axis Assessed by POP-Q Stage Improvement Based Upon Prolapse Grading of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Between Baseline and Six Months

  6 months

• Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline at 24 Months

  24 months

• Percentage of Participants With POP-Q Stage Improvement After POP Repair With Axis Assessed by POP-Q Stage Improvement Based Upon Prolapse Grading of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Between Baseline at 36 Months

  36 months

• Change in Participant Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 6 Months

  Baseline and 6 months

Study Arms (1)

AXIS Allograft Dermis

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

Other: Axis

Interventions

Axis OTHER

Coloplast's Axis™ Allograft Dermis is used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.

AXIS Allograft Dermis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 human tissue in the anterior, posterior, or combined (anterior and posterior) compartments at the institutions designated for this study.

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.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (5)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Boston Urogynecology Associates

Cambridge, Massachusetts, 02138, United States

Location

Female Pelvic Medicine and Urogynecology Institute of MI/Grand Rapids Women's Health

Grand Rapids, Michigan, 49503, United States

Location

The Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Philadelphia Urosurgical Associates

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study N was small.

Results Point of Contact

• Title: Cathy Bartz
• Organization: Coloplast

uscmba@coloplast.com

612-834-3127

Study Officials

• Kristine Whitmore, MD

  Virtua Female Pelvic Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 1, 2012
• Study Start: November 1, 2011
• Primary Completion: November 11, 2018
• Study Completion: November 11, 2018
• Last Updated: June 30, 2020
• Results First Posted: June 18, 2020

Record last verified: 2020-06

Locations

US (5)