N/A
N=74
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT01541748 ↗Enrolled (actual)
74
Serious AEs
1.5%
Results posted
Jun 2020
Primary outcome: Primary: 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. — 35; 4; 7 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Axis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Coloplast A/S
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
35; 4; 7 | — |
| SECONDARY 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 |
63; 1; 1 | — |
| SECONDARY 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 |
46; 5; 6 | — |
| SECONDARY 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 |
36; 2; 8 | — |
| SECONDARY 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 |
27; 7; 9 | — |
| SECONDARY 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 |
-3.1; 16.8 | — |
| SECONDARY 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 |
-2.9; 16.8 | — |
| SECONDARY 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 |
-2.2 | — |
| SECONDARY 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 |
11.9; 16.8 | — |
| SECONDARY Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 12 Months |
87.5 | — |
| SECONDARY Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 24 Months |
87.0 | — |
| SECONDARY Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 36 Months |
88.1 | — |
| SECONDARY 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 |
1.7; -.08; -1.0; -1.5; -1.1; 0.5 | — |
| SECONDARY 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 |
1.8; -0.7; -0.3; -0.9; -1.0; -1.5 | — |
| SECONDARY Percentage of Participants Who Had Surgical Revision of the Index Prolapse Compartment(s) After Pelvic Organ Prolapse Repair With Axis |
— | — |
| SECONDARY 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. |
83.2; 81.7; 87.9; 86.8; 86.2 | — |
| SECONDARY 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 |
108.3; -58; -62.5; -69.4; -62.0; -62.7 | — |
| SECONDARY 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 |
65.8; -31.5; -41.2; -46; -48.8; -44.9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01541748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.