Success based on a composite of objective and subjective measures:

1. Objective success was achieved by the subject having an anatomic outcome defined as the leading edge of prolapse at or above the hymen in the operated compartment:

   • Anterior segment: Leading edge of anterior prolapse was at or above 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 single compartment apical prolapse.

2. 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).

3. 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 since index surgery (i.e., 'treated segment' refers to the target compartment).

337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study [NCT01945580], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.

A co-primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Uphold LITE vs. NTR for safety by comparing the overall complication rate (device-related and/or procedure-related SAEs) at 36 months

337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study [NCT01945580], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.

Provides a summary of the number of subjects who reported mesh erosion or exposure at each of the study follow-up time points.

The population includes the 225 subjects in the Transvaginal repair with mesh (Uphold LITE) arm of the study.

Number of subjects with the following device-related and/or procedure-related adverse events: de novo dyspareunia, pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation, and/or de novo voiding dysfunction. The Intent-to-Treat (ITT) population includes all enrolled subjects who had a surgery initiated; the As Treated population includes all subjects who successfully completed the surgical procedure. Both ITT and As Treated populations are identical to the Overall Number of Participants Analyzed.

337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study [NCT01945580], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.

The Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three components: Pelvic Organ Prolapse Distress Inventory (POPDI; 6 questions), Urinary Distress Inventory (UDI; 6 questions), and Colorectal-Anal Distress Inventory (CRADI; 8 questions). 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). Reported outcomes are the change from Baseline for the time periods indicated.

225 Uphold LITE arm subjects and 485 Native Tissue Repair arm subjects had available questionnaire data at Baseline. The number of participants at each follow up time point represents subjects who had available questionnaire data at Baseline and the time point indicated.

The Pelvic Floor Impact Questionnaire (PFIQ-7) is composed of 3 separate but related assessments: the Urinary Impact Questionnaire, addresses the impact of urinary incontinence symptoms, the Colorectal-Anal Impact Questionnaire addresses the impact of colorectal-anal or bowel symptoms, and the Pelvic Organ Prolapse Impact Questionnaire 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, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.

222 Uphold LITE arm subjects and 485 Native Tissue Repair arm subjects had available questionnaire data at Baseline. The number of participants at each follow up time point represents subjects who had available questionnaire data at Baseline and the time point indicated.

The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated short form that can be used to ascertain improvement in sexual function and desire in women undergoing therapy for pelvic organ prolapse. The PISQ-12 consists of 12 questions graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Values range from 0-48 and a higher score indicates better sexual function. Reported outcomes are the change from Baseline for the time periods indicated.

90 Uphold LITE arm subjects and 234 Native Tissue Repair arm subjects had available questionnaire data at Baseline. The number of participants at each follow up time point represents those who had available questionnaire data at Baseline and the time point indicated.

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. There are seven (7) questions each with a maximum score of 10 and a possible score range of 0-70. Reported outcomes are the change from Baseline for the time periods indicated.

225 Uphold LITE arm subjects and 485 Native Tissue Repair arm subjects had available questionnaire data at Baseline. The number of participants at each follow up time point represents subjects who had available questionnaire data at Baseline and the time point indicated.

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 pelvic organ prolapse. 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.

289 subjects were enrolled in the Uphold LITE study--225 in the Uphold LITE arm and 64 in the NTR arm. 421 subjects from AUGS PFD Registry (146 subjects from Xenform™ 522 study, 69 subjects from MatriStem® 522 study, and 206 from Restorelle® 522 study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall. The number of participants for each follow up time point represents subjects who had available questionnaire data at that time point.

Compares the office-based and surgical intervention for recurrent prolapse and complications between the Uphold LITE arm and the NTR arm 36 months from the index procedure in the Intent-to-Treat (ITT) and As Treated populations. The ITT population includes all enrolled subjects who had a surgery initiated; the As Treated population includes all subjects who successfully completed the surgical procedure. Both ITT and As Treated populations are identical to the Overall Number of Participants Analyzed.

337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study [NCT01945580], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.

Secondary efficacy endpoint defined similarly to the primary efficacy endpoint except for the definition of objective success. Objective success for this endpoint is defined as:

• Anatomic success in the operated compartment was achieved by:

  • 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 single compartment apical prolapse.

• Subjective success was achieved if the patient denied symptoms of vaginal bulging per PFDI-20 question 3, answering "no" or "yes" but "Not at all" bothersome (< 2).

• No retreatment for POP: No additional surgical treatment for POP in 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).

337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study [NCT01945580], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.