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

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

Population: 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.

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

Population: The 19 participants who completed the PISQ-12 at the 6 month follow up visit.

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

Population: The 17 participants who completed the PISQ-12 at the twelve month follow up visit.

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

Population: The 13 participants who completed the PISQ-12 at the 24 month follow up visit.

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

Population: The 19 participants who completed the PISQ-12 at the 36 month follow up visit.

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

Population: 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.

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

Population: 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.

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

Population: Participants who completed the Pelvic Floor Distress Inventory (PFDI-20) Questionnaire at 6 week, 6 month, 12 Month, 24 Month, 36 Month visits.

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

Population: Subjects who completed the Pelvic Floor Impact Questionnaire Questionnaire at 6 weeks, 6 month, 12 Month, 24 Month, and 36 Month visits.

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

Population: The 48 participants who completed the PGI-I at the 12 month follow up visit.

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

Population: The 46 participants who completed the PGI-I at the 24 month follow up visit.

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

Population: The 42 participants who completed the PGI-I at the 36 month follow up visit.

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

Population: 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.

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

Population: 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

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: The subjects who completed the SSQ-8 Questionnaire at the 6 week, 6 month, 12 month, 24 month, and 36 month visits.