Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AXIS Allograft Dermis Participants receiving AXIS Allograft Dermis for anterior, posterior or combined (anterior and posterior) female pelvic floor repair. |
Other: Axis
Coloplast's Axis™ Allograft Dermis is used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
|
Outcome Measures
Primary Outcome Measures
- 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. [1 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
Secondary Outcome Measures
- 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]
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
- 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]
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
- 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]
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
- 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]
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
- 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]
The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
- 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 [Baseline and 12 months]
The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
- 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 [Baseline and 24 months]
The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
- 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 [Baseline and 36 months]
The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
- Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 12 Months [12 months]
The PGI-I Index consists of one question and was collected at 12 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response.
- Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 24 Months [24 month]
The PGI-I Index consists of one question and was collected at 24 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response.
- Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 36 Months [36 months]
The PGI-I Index consists of one question and was collected at 36 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response.
- 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 [Baseline and 6 weeks, 6 months, 12 months, 24 months, 36 months]
The Visual analog scales (VAS) Questionnaire is a questionnaire that asks the participant to mark a place on a scale that aligns with their level of pain. Participants were asked to make a vertical mark on a 10 centimeter line marked with "No Pain" and "Worst Pain" at each end and the line was measured to the tenths decimal place. A lower score indicates less pain.
- 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 [Baseline and 6 weeks, 6 months, 1 year, 2 years, 3 years]
The Visual analog scales (VAS) Questionnaire is a questionnaire that asks the participant to mark a place on a scale that aligns with their level of pain. Participants were asked to make a vertical mark on a 10 centimeter line with the left end marker labeled "No Pain" and the right end marker labeled "Worst Pain." The line was measured to the tenths decimal place. Zero was the minimum value and 10 was the maximum value. Higher scores indicated a greater amount of pain.
- Percentage of Participants Who Had Surgical Revision of the Index Prolapse Compartment(s) After Pelvic Organ Prolapse Repair With Axis [3 year]
Percentage of participants who had surgical revision of the index prolapse compartment(s) after pelvic organ prolapse repair with Axis from the time of the index procedure to the end of study visit.
- 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. [6 week, 6 month, 12 month, 24 month, and 36 month visits]
The Surgical Satisfaction Questionnaire (SSQ-8) is a validated questionnaire consisting of eight questions assessing participant satisfaction with the results of their surgery to correct urinary incontinence and/or pelvic organ prolapse. Scoring is implemented with the mean average of the 8 scores multiplied by 25, yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction.
- 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 [Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months]
The Pelvic Floor Distress Inventory Questionnaire (PFDI-20) is a questionnaire with 20 questions that measures symptom distress and impact of health-related quality of life. The PFDI-20 has three scales: Pelvic Organ Prolapse Distress Inventory (POPDI-6), Colorectal-Anal Distress Inventory (CRADI-8), and Urinary Distress Inventory (UDI-6). Each of the 3 scales of the PFDI-20 is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 to 300. Higher scores indicate more distress.
- 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 [Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months]
The Pelvic Floor Impact Questionnaire (PFIQ) measures impact of bladder, bowel, and vaginal symptoms on daily physical activity, travel, social/relationships, and emotional health. The PFIQ-7 has three scales: the Urinary Impact Questionnaire (UIQ-7), the Colorectal-Anal Impact Questionnaire (CRAIQ-7), and the Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7). Response options range from 0 ("not at all") to 3 ("quite a bit"). Per scale, the mean score of answered items is multiplied by 33.3 to obtain the scale score (range 0-100) [4]. Summary scores are calculated by adding up the scale scores (range 0-300) [4]. Higher scores indicate more impact on daily activity.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic Florida | Weston | Florida | United States | 33331 |
| 2 | Boston Urogynecology Associates | Cambridge | Massachusetts | United States | 02138 |
| 3 | Female Pelvic Medicine and Urogynecology Institute of MI/Grand Rapids Women's Health | Grand Rapids | Michigan | United States | 49503 |
| 4 | The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | United States | 18103 |
| 5 | Philadelphia Urosurgical Associates | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Coloplast A/S
Investigators
- Principal Investigator: Kristine Whitmore, MD, Virtua Female Pelvic Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.- CP009SU
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Seventy-four subjects were consented. Five subjects did not meet inclusion/exclusion criteria and one subject was not implanted with a study device. |
| Arm/Group Title | Axis Allograft Dermis |
|---|---|
| Arm/Group Description | Subjects with clinically significant pelvic organ prolapse Stage greater than or equal to 2, with surgical intervention using Axis device in the anterior, posterior, or combined (anterior and posterior) compartments. |
| Period Title: Overall Study | |
| STARTED | 74 |
| COMPLETED | 43 |
| NOT COMPLETED | 31 |
Baseline Characteristics
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair. |
| Overall Participants | 74 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
60.4
(11.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
74
100%
|
| Male |
0
0%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
74
100%
|
| BMI (Kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Kg/m^2] |
27.9
(4.8)
|
| Diabetes (Count of Participants) | |
| Count of Participants [Participants] |
3
4.1%
|
Outcome Measures
| Title | 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. |
|---|---|
| Description | 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 |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair. |
| Measure Participants | 46 |
| Cured |
35
47.3%
|
| Improved |
4
5.4%
|
| Failed |
7
9.5%
|
| Title | 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 |
|---|---|
| Description | 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 |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair. |
| Measure Participants | 65 |
| Cured |
63
85.1%
|
| Improved |
1
1.4%
|
| Failed |
1
1.4%
|
| Title | 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 |
|---|---|
| Description | 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 |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair at 6 months |
| Measure Participants | 57 |
| Cured |
46
62.2%
|
| Improved |
5
6.8%
|
| Failed |
6
8.1%
|
| Title | 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 |
|---|---|
| Description | 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 |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair. |
| Measure Participants | 46 |
| Cured |
36
48.6%
|
| Improved |
2
2.7%
|
| Failed |
8
10.8%
|
| Title | 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 |
|---|---|
| Description | 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 |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair. |
| Measure Participants | 43 |
| Cured |
27
36.5%
|
| Improved |
7
9.5%
|
| Failed |
9
12.2%
|
| Title | 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 |
|---|---|
| Description | The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. |
| Time Frame | Baseline and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 19 participants who completed the PISQ-12 at the 6 month follow up visit. |
| Arm/Group Title | Axis Allograft Dermis |
|---|---|
| Arm/Group Description | Participants with clinically significant pelvic organ prolapse Stage greater than or equal to 2, with surgical intervention using Axis device in the anterior, posterior, or combined (anterior and posterior) compartments. |
| Measure Participants | 19 |
| 6 months |
-3.1
(10.4)
|
| Baseline |
16.8
(8.1)
|
| Title | 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 |
|---|---|
| Description | The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. |
| Time Frame | Baseline and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 17 participants who completed the PISQ-12 at the twelve month follow up visit. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior and/or posterior compartment. |
| Measure Participants | 17 |
| 12 months |
-2.9
(6.9)
|
| Baseline |
16.8
(8.1)
|
| Title | 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 |
|---|---|
| Description | The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. |
| Time Frame | Baseline and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 13 participants who completed the PISQ-12 at the 24 month follow up visit. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior and/or posterior compartment. |
| Measure Participants | 13 |
| Mean (Standard Deviation) [score on a scale] |
-2.2
(5.1)
|
| Title | 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 |
|---|---|
| Description | The PISQ-12 is the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Sexual Function in women after pelvic organ prolapse repair with Axis Allograft Dermis measured by PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totaling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. |
| Time Frame | Baseline and 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 19 participants who completed the PISQ-12 at the 36 month follow up visit. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior and/or posterior compartment. |
| Measure Participants | 19 |
| 36 month |
11.9
(6.9)
|
| Baseline |
16.8
(8.1)
|
| Title | Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 12 Months |
|---|---|
| Description | The PGI-I Index consists of one question and was collected at 12 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 48 participants who completed the PGI-I at the 12 month follow up visit. |
| Arm/Group Title | Axis Allograft Dermis |
|---|---|
| Arm/Group Description | Participants implanted with Axis Allograft Dermis who completed the PGI-I Questionnaire at 12 months. |
| Measure Participants | 48 |
| Number [percentage of participants] |
87.5
118.2%
|
| Title | Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 24 Months |
|---|---|
| Description | The PGI-I Index consists of one question and was collected at 24 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response. |
| Time Frame | 24 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 46 participants who completed the PGI-I at the 24 month follow up visit. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | The PGI-I Index consists on one question and was collected at 6 weeks. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including "very much better," "much better," "a little better," "no change," "a little worse," "much worse" and "very much worse" and the subject chooses one response. |
| Measure Participants | 46 |
| Number [percentage of participants] |
87.0
117.6%
|
| Title | Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 36 Months |
|---|---|
| Description | The PGI-I Index consists of one question and was collected at 36 months. The question is "Check the box that best describes how your condition is now, compared with how it was before you had the operation." There are seven possible responses including, "very much better," "much better," "a little better," "no change," "a little worse," "much worse," and "very much worse and the subject chooses one response. |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 42 participants who completed the PGI-I at the 36 month follow up visit. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Participants implanted with Axis Allograft Dermis |
| Measure Participants | 42 |
| Number [percentage of participants] |
88.1
119.1%
|
| Title | 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 |
|---|---|
| Description | The Visual analog scales (VAS) Questionnaire is a questionnaire that asks the participant to mark a place on a scale that aligns with their level of pain. Participants were asked to make a vertical mark on a 10 centimeter line marked with "No Pain" and "Worst Pain" at each end and the line was measured to the tenths decimal place. A lower score indicates less pain. |
| Time Frame | Baseline and 6 weeks, 6 months, 12 months, 24 months, 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The participants who completed the VAS Questionnaire for Pelvic/Bladder Pain with Daily Activity at the 6 week, 6 month, 12 month, 24 month, and 36 month visits. Some participants either did not complete the questionnaire or did not complete it correctly and this accounts for the lesser total number of participant questionnaires analyzed. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair. |
| Measure Participants | 61 |
| Baseline |
1.7
(2.6)
|
| 6 week |
-.08
(2.4)
|
| 6 month |
-1.0
(2.7)
|
| 12 month |
-1.5
(2.8)
|
| 24 month |
-1.1
(2.4)
|
| 36 month |
0.5
(1.6)
|
| Title | 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 |
|---|---|
| Description | The Visual analog scales (VAS) Questionnaire is a questionnaire that asks the participant to mark a place on a scale that aligns with their level of pain. Participants were asked to make a vertical mark on a 10 centimeter line with the left end marker labeled "No Pain" and the right end marker labeled "Worst Pain." The line was measured to the tenths decimal place. Zero was the minimum value and 10 was the maximum value. Higher scores indicated a greater amount of pain. |
| Time Frame | Baseline and 6 weeks, 6 months, 1 year, 2 years, 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed the VAS Questionnaire for Pelvic/Bladder Pain with Sexual Activity at the 6 week, 6 month, 12 month, 24 month, and 36 month visits. Some participants were not sexually active and this accounts for the lesser total number of participant questionnaires analyzed at certain visit intervals. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair.. |
| Measure Participants | 48 |
| Baseline |
1.8
(2.9)
|
| 6 Week |
-0.7
(2.9)
|
| 6 Month |
-0.3
(3.4)
|
| 12 Month |
-0.9
(2.9)
|
| 24 Month |
-1.0
(3.3)
|
| 36 Month |
-1.5
(3.3)
|
| Title | Percentage of Participants Who Had Surgical Revision of the Index Prolapse Compartment(s) After Pelvic Organ Prolapse Repair With Axis |
|---|---|
| Description | Percentage of participants who had surgical revision of the index prolapse compartment(s) after pelvic organ prolapse repair with Axis from the time of the index procedure to the end of study visit. |
| Time Frame | 3 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The participants who had surgical revision of the index prolapse compartment(s) after pelvic organ prolapse repair with Axis from the time of the index procedure to the end of study visit. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Participants with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments. |
| Measure Participants | 68 |
| Count of Participants [Participants] |
0
0%
|
| Title | 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. |
|---|---|
| Description | The Surgical Satisfaction Questionnaire (SSQ-8) is a validated questionnaire consisting of eight questions assessing participant satisfaction with the results of their surgery to correct urinary incontinence and/or pelvic organ prolapse. Scoring is implemented with the mean average of the 8 scores multiplied by 25, yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction. |
| Time Frame | 6 week, 6 month, 12 month, 24 month, and 36 month visits |
Outcome Measure Data
| Analysis Population Description |
|---|
| The subjects who completed the SSQ-8 Questionnaire at the 6 week, 6 month, 12 month, 24 month, and 36 month visits. |
| Arm/Group Title | Axis Allograft Dermis |
|---|---|
| Arm/Group Description | Subjects with clinically significant pelvic organ prolapse Stage greater than or equal to 2, with surgical intervention using Axis device in the anterior, posterior, or combined (anterior and posterior) compartments. |
| Measure Participants | 65 |
| 6 Weeks |
83.2
(15.9)
|
| Month 6 |
81.7
(20.2)
|
| Month 12 |
87.9
(13.8)
|
| Month 24 |
86.8
(14.8)
|
| Month 36 |
86.2
(17.3)
|
| Title | 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 |
|---|---|
| Description | The Pelvic Floor Distress Inventory Questionnaire (PFDI-20) is a questionnaire with 20 questions that measures symptom distress and impact of health-related quality of life. The PFDI-20 has three scales: Pelvic Organ Prolapse Distress Inventory (POPDI-6), Colorectal-Anal Distress Inventory (CRADI-8), and Urinary Distress Inventory (UDI-6). Each of the 3 scales of the PFDI-20 is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 to 300. Higher scores indicate more distress. |
| Time Frame | Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed the Pelvic Floor Distress Inventory (PFDI-20) Questionnaire at 6 week, 6 month, 12 Month, 24 Month, 36 Month visits. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair. |
| Measure Participants | 60 |
| Baseline |
108.3
(59.6)
|
| 6 Week |
-58
(61.3)
|
| 6 Month |
-62.5
(63.4)
|
| 12 Month |
-69.4
(56.1)
|
| 24 Month |
-62.0
(63.6)
|
| 36 Month |
-62.7
(71.3)
|
| Title | 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 |
|---|---|
| Description | The Pelvic Floor Impact Questionnaire (PFIQ) measures impact of bladder, bowel, and vaginal symptoms on daily physical activity, travel, social/relationships, and emotional health. The PFIQ-7 has three scales: the Urinary Impact Questionnaire (UIQ-7), the Colorectal-Anal Impact Questionnaire (CRAIQ-7), and the Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7). Response options range from 0 ("not at all") to 3 ("quite a bit"). Per scale, the mean score of answered items is multiplied by 33.3 to obtain the scale score (range 0-100) [4]. Summary scores are calculated by adding up the scale scores (range 0-300) [4]. Higher scores indicate more impact on daily activity. |
| Time Frame | Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who completed the Pelvic Floor Impact Questionnaire Questionnaire at 6 weeks, 6 month, 12 Month, 24 Month, and 36 Month visits. |
| Arm/Group Title | AXIS Allograft Dermis |
|---|---|
| Arm/Group Description | Adult females with POP-Q Stage greater than or equal to 2 receiving AXIS Allograft Dermis for anterior, posterior or combined female pelvic floor repair. |
| Measure Participants | 60 |
| Baseline |
65.8
(63.4)
|
| 6 Week |
-31.5
(56.7)
|
| 6 Month |
-41.2
(66.5)
|
| 12 Month |
-46
(72.1)
|
| 24 Month |
-48.8
(65.9)
|
| 36 Month |
-44.9
(70.8)
|
Adverse Events
| Time Frame | Adverse event data was collected from the index procedure through study completion. Thus, the timeframe duration over which adverse events were collected is three years post index procedure. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | AXIS Allograft Dermis | |
| Arm/Group Description | Participants implanted with AXIS Allograft Dermis. | |
All Cause Mortality |
||
| AXIS Allograft Dermis | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/68 (0%) | |
Serious Adverse Events |
||
| AXIS Allograft Dermis | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/68 (1.5%) | |
| Infections and infestations | ||
| Pelvic abscess. | 1/68 (1.5%) | 1 |
| Surgical and medical procedures | ||
| Hematoma | 1/68 (1.5%) | 1 |
| Wound dehiscence | 1/68 (1.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| AXIS Allograft Dermis | ||
| Affected / at Risk (%) | # Events | |
| Total | 7/68 (10.3%) | |
| Skin and subcutaneous tissue disorders | ||
| Wound dehiscence | 4/68 (5.9%) | 4 |
| Surgical and medical procedures | ||
| Pain (Lasting > 6 weeks post-operatively) | 3/68 (4.4%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Cathy Bartz |
|---|---|
| Organization | Coloplast |
| Phone | 612-834-3127 |
| uscmba@coloplast.com |
- CP009SU