Clinical trial NCT01541748: Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Official title: Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 6 weeks
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 24 months
measure: 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
timeFrame: 36 months
measure: 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
timeFrame: Baseline and 6 months
measure: Change in Patient 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 12 Months
timeFrame: Baseline and 12 months
measure: Change in Patient 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 24 Months
timeFrame: Baseline and 24 months
measure: Change in Patient 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 36 Months
timeFrame: Baseline and 36 months
measure: Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 12 Months
timeFrame: 12 months
measure: Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 24 Months
timeFrame: 24 month
measure: Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 36 Months
timeFrame: 36 months
measure: Change in Pelvic/Bladder Pain With Daily Activity Visual Analog Scale (VAS) Questionnaire From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
timeFrame: Baseline and 6 weeks, 6 months, 12 months, 24 months, 36 months
measure: Change in Pelvic/Bladder Pain With Sexual Activity Visual Analog Scale (VAS) Questionnaire From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
timeFrame: Baseline and 6 weeks, 6 months, 1 year, 2 years, 3 years
measure: Percentage of Participants Who Had Surgical Revision of the Index Prolapse Compartment(s) After Pelvic Organ Prolapse Repair With Axis
timeFrame: 3 year
measure: Ratings for the Validated Surgical Satisfaction Questionnaire (SSQ-8) in Women Following Surgery to Correct Pelvic Organ Prolapse Repair With Axis Allograft Dermis at the 6 Week, 6 Month, 12 Month, 24 Month, and 36 Month Visits.
timeFrame: 6 week, 6 month, 12 month, 24 month, and 36 month visits
measure: Change in Pelvic Floor Distress Inventory (PFDI-20) Questionnaire After Pelvic Organ Prolapse Repair With Axis Allograft Dermis From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, and 36 Months
timeFrame: Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months
measure: Change in the Participants Response on the Pelvic Floor Impact Questionnaire (PFIQ) From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months
timeFrame: Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Cambridge
country: United States
facility: Boston Urogynecology Associates
state: Massachusetts
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine and Urogynecology Institute of MI/Grand Rapids Women's Health
state: Michigan
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Urosurgical Associates
state: Pennsylvania
Study officials:
affiliation: Virtua Female Pelvic Medicine
name: Kristine Whitmore, MD
role: PRINCIPAL_INVESTIGATOR
References: