Xenform Postmarket Surveillance Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01945580
• Collaborator: (none)
• Enrollment: 374
• Locations: 25
• Arms: 2
• Actual Duration (Months): 72
• Patients Per Site: 15
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Prolapse Repair	N/A

Detailed Description

The primary objective is to evaluate clinical effectiveness of transvaginal repair with Xenform against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Xenform-related complications and subject reported outcomes.

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

Additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with Xenform to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point.

The secondary endpoints of the study include assessments of complications and subject reported outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 374 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Non-Randomized, Parallel Cohort, Multi-Center Study of Xenform vs. Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse
• Actual Study Start Date: Feb 10, 2014
• Actual Primary Completion Date: Feb 12, 2020
• Actual Study Completion Date: Feb 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Xenform Prolapse Repair with Xenform Soft Tissue Repair Matrix	Procedure: Prolapse Repair; Transvaginal anterior/apical pelvic organ prolapse repair; Other Names: Transvaginal Prolapse POP Repair Anterior Apical
Active Comparator: Control Prolapse Repair with Native Tissue Only	Procedure: Prolapse Repair; Transvaginal anterior/apical pelvic organ prolapse repair; Other Names: Transvaginal Prolapse POP Repair Anterior Apical

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Success at 36 Months [36 Months]

   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

2. Number of Participants With One or More Serious Device-related and/or Procedure-Related Adverse Events [36 months]

   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.

Secondary Outcome Measures

1. Number of Participants With Mesh Erosion [36 months]

   Incidence of Mesh Erosion at 36 months

2. Number of Participants With Mesh Exposure [36 Months]

   Incidence of mesh exposure at 36 months

3. Number of Participants With de Novo Dyspareunia [36 months]

   Incidence of de novo dyspareunia at 36 months

4. Subject Specific Outcomes Measured With the Pelvic Floor Impact Questionnaire (PFIQ-7)] [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.

5. Subject Specific Outcomes Measured by the Pelvic Floor Symptoms Per the Pelvic Floor Distress Inventory (PFDI-20) [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.

6. Subject Specific Outcomes Measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [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.

7. Subject Specific Outcomes: Pain Measured by the TOMUS Pain Scale [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.

8. Subject Improvement Measured by the Patient Global Impression of Improvement for Prolapse (PGI-I) [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.

9. Number of Participants With Re-Intervention or Re-Surgery [36 months]

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

10. Surgical Success [36 months]

    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)

11. Incidence of Complications [36 Months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is female

• Subject is at least 18 years of age

• Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 (for prolapse of the anterior compartment alone) or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments).

• Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")

• Subject or subject's legally authorized representative is willing to provide written informed consent

• Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

• Subject is pregnant or intends to become pregnant during the study

• Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis

• Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)

• Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area

• Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)

• Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis, polymyalgia rheumatica)

• Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis

• Subject has uncontrolled diabetes mellitus (DM)

• Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)

• Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)

• Subject is not able to conform to the modified dorsal lithotomy position

• Subject is currently participating in or plans to participate in another device or drug study during this study

• Subject has a known sensitivity to any Xenform component

• Subject has had previous prolapse repair with mesh in the target compartment

• Subject is planning to undergo a concomitant prolapse repair with use of mesh in the non-target compartment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine Medical Center	Orange	California	United States	92868
2	Emory Hospital	Atlanta	Georgia	United States	30322
3	Augusta University	Augusta	Georgia	United States	30912
4	Cherokee Womens Health Specialist	Canton	Georgia	United States	30114
5	NorthShore University Health System	Skokie	Illinois	United States	60076
6	Acadia Women's Health	Crowley	Louisiana	United States	70526
7	Chesapeake Urology Research Associates	Hanover	Maryland	United States	21061
8	Chesapeake Urology Research Associates	Owings Mills	Maryland	United States	21117
9	Mount Auburn Hospital	Cambridge	Massachusetts	United States	02138
10	Beyer Research	Kalamazoo	Michigan	United States	49009
11	Cooper University Hospital	Voorhees	New Jersey	United States	08043
12	University of Buffalo	Buffalo	New York	United States	14222
13	Beth Israel Medical Center	New York	New York	United States	10003
14	NYU Langone Medical Center	New York	New York	United States	10016
15	University of North Carolina	Chapel Hill	North Carolina	United States	27599
16	Carolina Urology Partners	Gastonia	North Carolina	United States	28054
17	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
18	Prime Care of SEO	Dresden	Ohio	United States	43821
19	Prisma Health System	Greenville	South Carolina	United States	29605
20	Southern Urogynecology	West Columbia	South Carolina	United States	29169
21	Center for Pelvic Health	Franklin	Tennessee	United States	37067
22	Practice Research Organization	Dallas	Texas	United States	75230
23	Houston Metro Urology	Houston	Texas	United States	77030
24	Las Colinas ObGyn	Irving	Texas	United States	75062
25	MultiCare Women's Health Care	Covington	Washington	United States	98042

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Peter Rosenblatt, MD, Mount Auburn Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 20, 2018

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01945580
• Other Study ID Numbers: U9920; AUGS PFD Outcome Registry
• First Posted: Sep 18, 2013
• Last Update Posted: Apr 14, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Boston Scientific Corporation: POP; Transvaginal; Native Tissue Repair; Repair Augmented with Mesh; Biologic Graft; Pelvic Organ Prolapse
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

Participant Flow

Pre-assignment Detail

412 subjects were screened and 374 subjects were enrolled in the Xenform Postmarket Surveillance Study. 228 subjects were enrolled into the Xenform arm and 146 subjects into the NTR arm. 339 subjects from the AUGS PFD Registry (64 subjects from BSC's Uphold™ LITE 522 study [NCT01917968], 69 subjects from Acell's MatriStem® 522 study & 206 subjects 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 713 subjects overall

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Period Title: Overall Study
STARTED	228	485
COMPLETED	176	401
NOT COMPLETED	52	84

Baseline Characteristics

Arm/Group Title	Xenform	Control	Total
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Total of all reporting groups
Overall Participants	228	485	713
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.2 (12.7)	61.8 (10.5)	60.7 (11.4)
Sex: Female, Male (Count of Participants)
Female	228 100%	485 100%	713 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 11.8%	20 4.1%	47 6.6%
Not Hispanic or Latino	199 87.3%	457 94.2%	656 92%
Unknown or Not Reported	2 0.9%	8 1.6%	10 1.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	6 2.6%	11 2.3%	17 2.4%
Native Hawaiian or Other Pacific Islander	1 0.4%	1 0.2%	2 0.3%
Black or African American	16 7%	55 11.3%	71 10%
White	198 86.8%	409 84.3%	607 85.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	7 3.1%	9 1.9%	16 2.2%
Region of Enrollment (participants) [Number]
United States	228 100%	485 100%	713 100%
Smoking (Count of Participants)
Current	21 9.2%	38 7.8%	59 8.3%
Previous	41 18%	139 28.7%	180 25.2%
Never	164 71.9%	308 63.5%	472 66.2%
Not Recorded	2 0.9%	0 0%	2 0.3%
Diabetes (Count of Participants)
Count of Participants [Participants]	22 9.6%	63 13%	85 11.9%
Menopausal Status (Count of Participants)
Premenopausal	39 17.1%	54 11.1%	93 13%
Perimenopausal	19 8.3%	27 5.6%	46 6.5%
Postmenopausal	170 74.6%	404 83.3%	574 80.5%
Previous Pelvic Surgery (Count of Participants)
Count of Participants [Participants]	136 59.6%	235 48.5%	371 52%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Success at 36 Months
Description	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
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

412 subjects were screened and 374 subjects were enrolled in the Xenform Postmarket Surveillance Study. 228 subjects were enrolled into the Xenform arm and 146 subjects into the NTR arm. 339 subjects from the AUGS PFD Registry (64 subjects from BSC's Uphold™ LITE 522 study, 69 subjects from Acell's MatriStem® 522 study and 206 subjects 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 713 study subjects overall.

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	228	485
Count of Participants [Participants]	191 83.8%	390 80.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xenform, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	With type I error of 0.05 and type II error of 0.20 (power 80%), 362 subjects (181 subjects per arm) are needed to detect non-inferiority of transvaginal biologic to native tissue repair, using a margin of 12.0%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted Difference in Percentages
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 90%; -5.6 to 5.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The propensity adjusted treatment difference of Xenform transvaginal mesh (TVM) minus NTR was estimated and missing data was handled using multiple imputation method.

2. Primary Outcome

Title	Number of Participants With One or More Serious Device-related and/or Procedure-Related Adverse Events
Description	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.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

412 subjects were screened and 374 subjects were enrolled in the Xenform Postmarket Surveillance Study. 228 subjects were enrolled into the Xenform arm and 146 subjects into the NTR arm. 339 subjects from the AUGS PFD Registry (64 subjects from BSC's Uphold™ LITE 522 study, 69 subjects from Acell's MatriStem® 522 study and 206 subjects 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 713 study subjects overall.

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	228	485
Count of Participants [Participants]	12 5.3%	13 2.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Xenform, Control
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	With type I error of 0.05 and type II error of 0.10 (power 90%), 308 subjects (154 subjects per arm) are needed to detect non-inferiority with a margin of 11.6%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted Difference in Percentages
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 90%; -0.8 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	The propensity score adjusted difference in SAE rate of Xenform transvaginal mesh (TVM) vs. NTR was estimated.

3. Secondary Outcome

Title	Number of Participants With Mesh Erosion
Description	Incidence of Mesh Erosion at 36 months
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The population includes the 228 subjects in the Xenform arm of the study.

Arm/Group Title	Total	Mild	Moderate	Severe
Arm/Group Description	Inclusive	Measure of Severity	Measure of Severity	Measure of Severity
Measure Participants	228	228	228	228
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 NaN

4. Secondary Outcome

Title	Number of Participants With Mesh Exposure
Description	Incidence of mesh exposure at 36 months
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

The population includes the 228 subjects in the Xenform arm of the study.

Arm/Group Title	Total	Mild	Moderate	Severe
Arm/Group Description	Inclusive	Measure of Severity	Measure of Severity	Measure of Severity
Measure Participants	228	228	228	228
Count of Participants [Participants]	2 0.9%	2 0.4%	0 0%	0 NaN

5. Secondary Outcome

Title	Number of Participants With de Novo Dyspareunia
Description	Incidence of de novo dyspareunia at 36 months
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

412 subjects were screened and 374 subjects were enrolled in the Xenform Postmarket Surveillance Study. 228 subjects were enrolled into the Xenform arm and 146 subjects into the NTR arm. 339 subjects from the AUGS PFD Registry (64 subjects from BSC's Uphold™ LITE 522 study, 69 subjects from Acell's MatriStem® 522 study and 206 subjects 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 713 study subjects overall.

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	228	485
Count of Participants [Participants]	2 0.9%	6 1.2%

6. Secondary Outcome

Title	Subject Specific Outcomes Measured With the Pelvic Floor Impact Questionnaire (PFIQ-7)]
Description	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.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The 174 Xenform arm participants and 399 Native Tissue Repair arm participants are indicative of the available information at the 36 month timepoint (i.e. the number of participants who completed the PFIQ-7 questionnaire at Baseline and 36 months).

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	174	399
Mean (Standard Deviation) [score on a scale]	-55.2 (62.8)	-41.9 (55.0)

7. Secondary Outcome

Title	Subject Specific Outcomes Measured by the Pelvic Floor Symptoms Per the Pelvic Floor Distress Inventory (PFDI-20)
Description	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.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The 175 Xenform arm participants and 400 Native Tissue Repair arm participants are indicative of the available information at the 36 month timepoint (i.e. the number of participants who completed the PFDI-20 questionnaire at Baseline and 36 months).

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	175	400
Mean (Standard Deviation) [score on a scale]	-80.8 (58.6)	-77.2 (56.1)

8. Secondary Outcome

Title	Subject Specific Outcomes Measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Description	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.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The 78 Xenform arm participants and 156 Native Tissue Repair arm participants are indicative of the available information at the 36 month timepoint (i.e. the number of participants who completed the PISQ-12 questionnaire at Baseline and 36 months).

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	78	156
Mean (Standard Deviation) [score on a scale]	5.0 (7.2)	4.3 (5.8)

9. Secondary Outcome

Title	Subject Specific Outcomes: Pain Measured by the TOMUS Pain Scale
Description	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.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The 175 Xenform arm participants and 399 Native Tissue Repair arm participants are indicative of the available information at the 36 month timepoint (i.e. the number of participants who completed the TOMUS pain scale at Baseline and 36 months).

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	175	399
Mean (Standard Deviation) [score on a scale]	-4.8 (8.8)	-4.0 (8.3)

10. Secondary Outcome

Title	Subject Improvement Measured by the Patient Global Impression of Improvement for Prolapse (PGI-I)
Description	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.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The 175 Xenform arm participants and 399 Native Tissue Repair arm participants are indicative of the available information at the 36 month timepoint (i.e. the number of participants who completed the PGI-I at Baseline and 36 months).

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	175	399
Mean (Standard Deviation) [score on a scale]	1.6 (0.9)	1.4 (0.9)

11. Secondary Outcome

Title	Number of Participants With Re-Intervention or Re-Surgery
Description	Absence of re-intervention or re-surgery for recurrence or persistence of POP or Xenform exposure/erosion
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

412 subjects were screened and 374 subjects were enrolled in the Xenform Postmarket Surveillance Study. 228 subjects were enrolled into the Xenform arm and 146 subjects into the NTR arm. 339 subjects from the AUGS PFD Registry (64 subjects from BSC's Uphold™ LITE 522 study, 69 subjects from Acell's MatriStem® 522 study and 206 subjects 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 713 study subjects overall.

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	228	485
Office-Based Intervention for Recurrent Prolapse	1 0.4%	2 0.4%
Surgical Intervention for Recurrent Prolapse	5 2.2%	15 3.1%
Office-Based Intervention for Complications	23 10.1%	40 8.2%
Surgical Intervention for Complications	15 6.6%	34 7%

12. Secondary Outcome

Title	Surgical Success
Description	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)
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

412 subjects were screened and 374 subjects were enrolled in the Xenform Postmarket Surveillance Study. 228 subjects were enrolled into the Xenform arm and 146 subjects into the NTR arm. 339 subjects from the AUGS PFD Registry (64 subjects from BSC's Uphold™ LITE 522 study, 69 subjects from Acell's MatriStem® 522 study and 206 subjects 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 713 study subjects overall.

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	228	485
Count of Participants [Participants]	183 80.3%	351 72.4%

13. Secondary Outcome

Title	Incidence of Complications
Description	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.
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

412 subjects were screened and 374 subjects were enrolled in the Xenform Postmarket Surveillance Study. 228 subjects were enrolled into the Xenform arm and 146 subjects into the NTR arm. 339 subjects from the AUGS PFD Registry (64 subjects from BSC's Uphold™ LITE 522 study, 69 subjects from Acell's MatriStem® 522 study and 206 subjects 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 713 study subjects overall.

Arm/Group Title	Xenform	Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair	Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
Measure Participants	228	485
pelvic pain	14 6.1%	28 5.8%
infection	25 11%	68 14%
vaginal shortening	0 0%	0 0%
atypical vaginal discharge	2 0.9%	3 0.6%
neuromuscular problems	3 1.3%	14 2.9%
vaginal scarring	3 1.3%	1 0.2%
de novo vaginal bleeding	3 1.3%	7 1.4%
fistula formation	0 0%	0 0%
de novo voiding dysfunction	35 15.4%	23 4.7%

Adverse Events

Time Frame	36 months
Adverse Event Reporting Description	412 subjects were screened and 374 subjects were enrolled in the Xenform Postmarket Surveillance Study. 228 subjects were enrolled into the Xenform arm and 146 subjects into the NTR arm. 339 subjects from the AUGS PFD Registry (64 subjects from BSC's Uphold™ LITE 522 study, 69 subjects from Acell's MatriStem® 522 study and 206 subjects 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 713 study subjects overall.
Arm/Group Title	Xenform		Control
Arm/Group Description	Prolapse Repair with Xenform Soft Tissue Repair Matrix Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair		Prolapse Repair with Native Tissue Only Prolapse Repair: Transvaginal anterior/apical pelvic organ prolapse repair
All Cause Mortality
	Xenform		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/228 (3.1%)		2/485 (0.4%)
Serious Adverse Events
	Xenform		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/228 (8.8%)		27/485 (5.6%)
Cardiac disorders
Cardiac Event - NEW	0/228 (0%)	0	6/485 (1.2%)	6
Cardiac Event - Worsening	1/228 (0.4%)	1	1/485 (0.2%)	1
Pulmonary Event, Specify - NEW	1/228 (0.4%)	1	0/485 (0%)	0
Gastrointestinal disorders
Constipation - NEW	2/228 (0.9%)	2	0/485 (0%)	0
Constipation - Worsening	1/228 (0.4%)	1	1/485 (0.2%)	1
Ileus/Bowel Obstruction	0/228 (0%)	0	4/485 (0.8%)	4
Other, Specify	0/228 (0%)	0	1/485 (0.2%)	1
General disorders
Death	1/228 (0.4%)	1	0/485 (0%)	0
Infections and infestations
Infection - Other, specify type	1/228 (0.4%)	1	4/485 (0.8%)	6
Pelvic Infection/Abscess	0/228 (0%)	0	2/485 (0.4%)	2
Pulmonary Event, Specify - NEW	0/228 (0%)	0	1/485 (0.2%)	1
Urinary Tract Infection (UTI), Lower	0/228 (0%)	0	2/485 (0.4%)	2
Injury, poisoning and procedural complications
Infection - Other, specify type	1/228 (0.4%)	1	0/485 (0%)	0
Ureteral Kink/Injury	0/228 (0%)	0	2/485 (0.4%)	2
Visceral Organ Injury	1/228 (0.4%)	1	1/485 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Tumor	1/228 (0.4%)	1	0/485 (0%)	0
Cancer	1/228 (0.4%)	1	0/485 (0%)	0
Other, Specify	0/228 (0%)	0	1/485 (0.2%)	1
Nervous system disorders
Alzheimers	1/228 (0.4%)	1	0/485 (0%)	0
Product Issues
Mesh Exposure in Vagina	1/228 (0.4%)	1	0/485 (0%)	0
Renal and urinary disorders
Difficult Emptying Bladder - NEW	3/228 (1.3%)	3	0/485 (0%)	0
Hematoma - Retropubic	0/228 (0%)	0	1/485 (0.2%)	1
Stress Incontinence - Worsening	1/228 (0.4%)	1	0/485 (0%)	0
Urinary Obstruction	1/228 (0.4%)	1	0/485 (0%)	0
Reproductive system and breast disorders
Pelvic Pain - NEW	1/228 (0.4%)	1	1/485 (0.2%)	1
Prolapse	1/228 (0.4%)	1	0/485 (0%)	0
Sensation of Bulge	1/228 (0.4%)	1	0/485 (0%)	0
Respiratory, thoracic and mediastinal disorders
Other, Specify	1/228 (0.4%)	1	0/485 (0%)	0
Pulmonary Event, Specify - Worsening	0/228 (0%)	0	1/485 (0.2%)	2
Surgical and medical procedures
Other, Specify	0/228 (0%)	0	1/485 (0.2%)	1
Vascular disorders
Bleeding	1/228 (0.4%)	1	0/485 (0%)	0
Bleeding Requiring Blood Transfusion	2/228 (0.9%)	2	0/485 (0%)	0
Thrombotic Event	0/228 (0%)	0	1/485 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Xenform		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	131/228 (57.5%)		312/485 (64.3%)
Cardiac disorders
Cardiac Event - NEW	0/228 (0%)	0	1/485 (0.2%)	1
Cardiac Event - Worsening	0/228 (0%)	0	1/485 (0.2%)	1
Gastrointestinal disorders
Constipation - NEW	6/228 (2.6%)	6	12/485 (2.5%)	12
Constipation - Worsening	4/228 (1.8%)	4	5/485 (1%)	5
Fecal Incontinence - NEW	6/228 (2.6%)	7	18/485 (3.7%)	18
Fecal Incontinence - Worsening	2/228 (0.9%)	2	6/485 (1.2%)	6
Hematoma - Retroperitoneal	0/228 (0%)	0	1/485 (0.2%)	1
Hemorrhoids	2/228 (0.9%)	2	3/485 (0.6%)	3
Ileus/Bowel Obstruction	0/228 (0%)	0	1/485 (0.2%)	1
Nausea	2/228 (0.9%)	2	0/485 (0%)	0
Neuromuscular Disorder, specify type	0/228 (0%)	0	8/485 (1.6%)	8
Other, Specify	3/228 (1.3%)	3	7/485 (1.4%)	7
General disorders
Cyst	4/228 (1.8%)	4	0/485 (0%)	0
Fever	1/228 (0.4%)	1	0/485 (0%)	0
Inflammation	0/228 (0%)	0	1/485 (0.2%)	1
Neuromuscular Disorder, specify type	0/228 (0%)	0	1/485 (0.2%)	1
Other, Specify	1/228 (0.4%)	1	2/485 (0.4%)	2
Pain, Other	1/228 (0.4%)	1	3/485 (0.6%)	3
Infections and infestations
Infection - Other, specify type	6/228 (2.6%)	9	9/485 (1.9%)	10
Other, Specify	0/228 (0%)	0	1/485 (0.2%)	1
Pelvic Infection/Abscess	2/228 (0.9%)	2	3/485 (0.6%)	3
Pulmonary Event, Specify - NEW	0/228 (0%)	0	2/485 (0.4%)	2
Upper Respiratory Infection	0/228 (0%)	0	1/485 (0.2%)	1
Urinary Tract Infection (UTI), Lower	26/228 (11.4%)	39	118/485 (24.3%)	164
Vaginal Infection	12/228 (5.3%)	14	16/485 (3.3%)	18
Injury, poisoning and procedural complications
Fracture	0/228 (0%)	0	1/485 (0.2%)	2
Other, Specify	1/228 (0.4%)	1	3/485 (0.6%)	3
Ureteral Kink/Injury	2/228 (0.9%)	2	0/485 (0%)	0
Visceral Organ Injury	1/228 (0.4%)	1	2/485 (0.4%)	2
Musculoskeletal and connective tissue disorders
Buttock Pain	4/228 (1.8%)	4	2/485 (0.4%)	2
Neuromuscular Disorder, specify type	1/228 (0.4%)	1	1/485 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasia, Non-Pelvic	0/228 (0%)	0	1/485 (0.2%)	1
Other, Specify	1/228 (0.4%)	1	0/485 (0%)	0
Nervous system disorders
Neuromuscular Disorder, specify type	2/228 (0.9%)	2	6/485 (1.2%)	6
Neurovascular Event	0/228 (0%)	0	1/485 (0.2%)	1
Other, Specify	1/228 (0.4%)	1	0/485 (0%)	0
Product Issues
Mesh Exposure in Vagina	2/228 (0.9%)	2	0/485 (0%)	0
Suture Exposure in Vagina	3/228 (1.3%)	3	19/485 (3.9%)	20
Psychiatric disorders
Other, Specify	1/228 (0.4%)	1	0/485 (0%)	0
Renal and urinary disorders
Difficulty Emptying Bladder - NEW	27/228 (11.8%)	28	24/485 (4.9%)	25
Difficulty Emptying Bladder - Worsening	2/228 (0.9%)	2	4/485 (0.8%)	4
Dysuria	3/228 (1.3%)	3	4/485 (0.8%)	7
Mixed Incontinence	1/228 (0.4%)	1	0/485 (0%)	0
Mixed Incontinence - Worsening	1/228 (0.4%)	1	0/485 (0%)	0
Mixed Urinary Incontinence	1/228 (0.4%)	1	1/485 (0.2%)	1
Other, Specify	2/228 (0.9%)	2	5/485 (1%)	5
Overactive Bladder	1/228 (0.4%)	1	6/485 (1.2%)	6
Stress Incontinence - NEW	8/228 (3.5%)	8	6/485 (1.2%)	6
Stress Incontinence - Worsening	4/228 (1.8%)	4	21/485 (4.3%)	21
Urge Incontinence - NEW	14/228 (6.1%)	15	8/485 (1.6%)	8
Urge Incontinence - Worsening	8/228 (3.5%)	8	25/485 (5.2%)	26
Urinary Frequency	5/228 (2.2%)	5	6/485 (1.2%)	6
Urinary Urgency	1/228 (0.4%)	1	5/485 (1%)	5
Weak Urinary Stream	0/228 (0%)	0	1/485 (0.2%)	1
Reproductive system and breast disorders
Dyspareunia - NEW (De Novo)	5/228 (2.2%)	6	11/485 (2.3%)	11
Dyspareunia - Worsening	2/228 (0.9%)	2	3/485 (0.6%)	3
Hematoma - Vaginal	3/228 (1.3%)	3	1/485 (0.2%)	1
Neuromuscular Disorder, specify type	1/228 (0.4%)	1	0/485 (0%)	0
Other, Specify	2/228 (0.9%)	2	4/485 (0.8%)	4
Pelvic Pain - NEW	17/228 (7.5%)	17	39/485 (8%)	41
Pelvic Pain - Worsening	1/228 (0.4%)	1	2/485 (0.4%)	2
Prolapse	20/228 (8.8%)	21	88/485 (18.1%)	93
Sensation of Bulge	35/228 (15.4%)	36	53/485 (10.9%)	55
Sensation of Pressure	2/228 (0.9%)	2	1/485 (0.2%)	1
Vaginal Atrophy	2/228 (0.9%)	2	3/485 (0.6%)	3
Vaginal Bleeding, De Novo	4/228 (1.8%)	4	9/485 (1.9%)	10
Vaginal Discharge, Atypical	2/228 (0.9%)	2	3/485 (0.6%)	3
Vaginal Scarring	3/228 (1.3%)	3	2/485 (0.4%)	2
Vaginal Wall Dehiscence	2/228 (0.9%)	2	1/485 (0.2%)	1
Vulvar Itching	0/228 (0%)	0	1/485 (0.2%)	1
Vulvar Lesion	0/228 (0%)	0	1/485 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Other, Specify	0/228 (0%)	0	1/485 (0.2%)	1
Skin and subcutaneous tissue disorders
Lichen Sclerosus	0/228 (0%)	0	1/485 (0.2%)	1
Rash	0/228 (0%)	0	1/485 (0.2%)	1
Skin Condition	0/228 (0%)	0	1/485 (0.2%)	1
Tissue Granulation	9/228 (3.9%)	10	33/485 (6.8%)	33
Vascular disorders
Bleeding	1/228 (0.4%)	1	1/485 (0.2%)	1
Hematoma - Other	0/228 (0%)	0	1/485 (0.2%)	1
Other, Specify	0/228 (0%)	0	1/485 (0.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor (including trade secrets but not including Results) from the proposed publication or presentation.