Trial Outcomes & Findings for Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study (NCT NCT01541748)

Seventy-four subjects were consented. Five subjects did not meet inclusion/exclusion criteria and one subject was not implanted with a study device.

Race and Ethnicity were not collected from any participant.

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

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

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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 from the time of the index procedure to the end of study visit.

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.

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.

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.