Xenform Postmarket Surveillance Study

The primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Xenform over NTR at 36 months as compared to baseline. Success was based on a composite of objective and subjective measures.

• Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (< 2).
• Anatomic success (in the operated compartment):

• Anterior segment: Leading edge of anterior prolapse was at or above the hymen or Pelvic Organ Prolapse Quantification System (POP-Q) point Ba ≤ 0.
• Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C < -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse.
• No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use

Co-primary endpoint of the study was to achieve non-inferiority of transvaginal mesh repair with Xenform to NTR for safety by comparing rates of serious device-related or serious procedure-related complications between baseline and the 36-month time point.

Incidence of Mesh Erosion at 36 months

Incidence of mesh exposure at 36 months

Incidence of de novo dyspareunia at 36 months

Improvement in subject specific outcomes at 36 months compared to baseline [quality of life (QOL) per the Pelvic Floor Impact Questionnaire (PFIQ-7)]

The PFIQ-7 is composed of three separate but related assessments: the UIQ-7 addresses the impact of urinary incontinence symptoms, the CRAIQ-7 addresses the impact of colorectal-anal or bowel symptoms, and the POPIQ-7 addresses impact of vaginal and pelvic symptoms. For each question, the low score (0) corresponds to "not at all" and the high score (3) corresponds to "quite a bit". The scores for the UIQ-7, CRAIQ-7 and POPIQ-7 are additive to yield the final PFIQ-7 score. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.

Reported score is change from baseline at 36 months.

Improvement in subject specific outcomes at 36 months compared to baseline [pelvic floor symptoms per the Pelvic Floor Distress Inventory (PFDI-20)]

The Pelvic Floor Distress Inventory-20 (PFDI-20) is complimentary to the PFIQ-7 and focuses on symptoms of distress in the same compartmentalized fashion as the PFIQ-7. Like the PFIQ-7, the PFDI-20 consists of three components: Urinary Distress Inventory (UDI; 6 questions), the Pelvic Organ Prolapse Distress Inventory (POPDI; 6 questions), and Colorectal-Anal Distress Inventory (CRADI; 8 questions). The scoring for the PFDI-20 is similar to the PFIQ-7 where each individual component score is summed. The total ranges from 0 to 300 with a higher score indicating a greater impact to QOL (i.e., distress symptoms are more noticeable) and a lower score indicating a lesser impact to QOL (i.e., distress symptoms are less noticeable).

The reported result is change from baseline at 36 months.

Improvement in subject specific outcomes at 36 months compared to baseline [change in sexual functioning per the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)]

This is a self-administered questionnaire and the responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Values range from 0 to 48 and a higher score indicates better sexual function.

The reported result is change from baseline at 36 months.

Improvement in subject specific outcomes at 36 months compared to baseline [pain per the TOMUS pain scale]

The TOMUS Pain Score, a visual analog instrument with a scale of 0 (no pain sensation) to 10 (most intense pain sensation imaginable), was used to assess pain associated with surgery for pelvic organ prolapse in this study. There are seven (7) questions each with a maximum score of 10 and a possible score range of 0-70).

The reported results are change from baseline at 36 months.

Assessment of subject's level of improvement, measured by the Patient Global Impression of Improvement for Prolapse (PGI-I)

The Patient Global Impression of Improvement (PGI-I) for prolapse symptoms is a validated QOL instrument that assesses patient perception of overall improvement after surgical interventions for POP.12 The scale rates the patient's improvement or worsening of prolapse symptoms relative to baseline. The scale is as follows: 1- Very much better; 2- Much better; 3- A little better; 4- No change; 5- A little worse; 6- Much worse; 7- Very much worse. Assessments were performed at 6-month intervals beginning 6 months after the index procedure.

Absence of re-intervention or re-surgery for recurrence or persistence of POP or Xenform exposure/erosion

Surgical success based on the following composite outcome:

• Subjective success: Patient denied symptoms of vaginal bulging per PFDI-20 question 3, answering "no" or "yes" but "Not at all" bothersome (˂ 2)
• Anatomic success (in the operated compartment):

• Anterior Segment: No anterior prolapse at or beyond the hymen or POP-Q point Ba ˂ 0
• Apical Segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C ˂ 1/2 TVL) for multi-compartment prolapse or POP-Q point C ˂ 0 for prolapse of the apical compartment alone
• No retreatment for POP (treated segment): No additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery ('treated segment' refers to the target compartments in this study, which are the anterior and apical compartments)

Incidence of the following device-related or procedure-related adverse events (AEs): pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction.