Uphold LITE Post-Market Surveillance Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01917968
• Collaborator: (none)
• Enrollment: 289
• Locations: 28
• Arms: 2
• Actual Duration (Months): 76.1
• Patients Per Site: 10.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare transvaginal mesh repair 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	Device: Uphold Lightweight Vaginal Support System; Procedure: Traditional native tissue repair	N/A

Detailed Description

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

The primary endpoint of the study is to achieve superiority of transvaginal repair with mesh (Uphold LITE) 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 mesh (Uphold LITE) 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: 289 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 Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse
• Actual Study Start Date: Oct 10, 2013
• Actual Primary Completion Date: Feb 12, 2020
• Actual Study Completion Date: Feb 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Uphold Lightweight Vaginal Support System Transvaginal repair with mesh (Uphold LITE)	Device: Uphold Lightweight Vaginal Support System; Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE); Other Names: Uphold LITE
Active Comparator: Traditional native tissue repair Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy	Procedure: Traditional native tissue repair; Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Outcome Measures

Primary Outcome Measures

1. Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months [36 Months]

   Success based on a composite of objective and subjective measures: 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. 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). 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).

2. Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months [36 months]

   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

Secondary Outcome Measures

1. Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects [6 Month, 12 Months, 18 Months, 24 Months, 36 Months, Overall]

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

2. Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events [36 Months]

   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.

3. Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects [6 Month, 12 Months, 18 Months, 24 Months, 36 Months]

   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.

4. Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects [6 Month, 12 Months, 18 Months, 24 Months, 36 Months]

   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.

5. Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects [6 Month, 12 Months, 18 Months, 24 Months, 36 Months]

   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.

6. Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects [6 Month, 12 Months, 18 Months, 24 Months, 36 Months]

   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.

7. Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects [6 Month, 12 Months, 18 Months, 24 Months, 36 Months]

   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.

8. Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure [36 Months]

   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.

9. Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months [36 Months]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is female

2. Subject is ≥18 years of age

3. 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 or (for prolapse of the anterior compartment alone) 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).

4. Subject reports of 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")

5. Subject or subject's legally authorized representative must be willing to provide written informed consent

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

Exclusion Criteria:

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

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

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

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

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

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

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

8. Subject has a previous prolapse repair with mesh in the target compartment

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

10. Subject is not able to conform to the modified dorsal lithotomy position

11. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that includes the pelvis

12. Subject has uncontrolled diabetes mellitus (DM)

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

14. Subject has a known hypersensitivity to polypropylene mesh

15. Subject is pregnant or intends to become pregnant during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Kirklin Clinic	Birmingham	Alabama	United States	35233
2	Montgomery Women's Health Associates, PC	Montgomery	Alabama	United States	36117
3	UCSD Health/Women's Pelvic Medicine Center	La Jolla	California	United States	92037
4	Sherry Thomas, PC	North Hollywood	California	United States	91301
5	University of CA Irvine Medical Center	Orange	California	United States	92868
6	Kaiser Permanente OB/GYN Urogynecology	San Diego	California	United States	92110
7	Scripps Clinic Carmel Valley	San Diego	California	United States	92130
8	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
9	The Florida Bladder Institute	Naples	Florida	United States	34109
10	NorthShore University HealthSystem	Evanston	Illinois	United States	60201
11	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
12	Capital Women's Care - Frederick	Frederick	Maryland	United States	21702
13	Las Vegas Minimally Invasive Surgery Women's Pelvic Health Center	Las Vegas	Nevada	United States	89135
14	Cooper University Hospital	Voorhees	New Jersey	United States	08043
15	Columbia University Irving Medical Center/NY Presbyterian Hospital	New York	New York	United States	10032
16	Presbyterian Hospital	Charlotte	North Carolina	United States	28210
17	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
18	St. Alexius Medical Center/Mid Dakota Clinic	Bismarck	North Dakota	United States	58501
19	University of Cincinnati Physicians Co	Cincinnati	Ohio	United States	45267
20	Institute for Female Pelvic Medicine & Reconstructive Surgery	Allentown	Pennsylvania	United States	18103
21	Institute for Female Pelvic Medicine & Reconstructive Surgery	North Wales	Pennsylvania	United States	19454
22	Prisma Health System	Greenville	South Carolina	United States	29605
23	Holston Medical Group at Seasons Center for Urogynecology & Advanced Pelvic Surgery	Bristol	Tennessee	United States	37620
24	Dr. M. Mitchell Silver, FACOG, PA	Nacogdoches	Texas	United States	25965
25	Kyle P. McMorries, MD	Nacogdoches	Texas	United States	75965
26	Women's OB/GYN Center	Pasadena	Texas	United States	77505
27	MultiCare Women's Health Care	Covington	Washington	United States	98042
28	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Karen Noblett, MD, University of California, Irvine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 28, 2018

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01917968
• Other Study ID Numbers: U8090
• First Posted: Aug 7, 2013
• Last Update Posted: May 20, 2021
• Last Verified: Apr 1, 2021

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

Study Results

Participant Flow

Pre-assignment Detail

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.

Arm/Group Title	Uphold Lightweight Vaginal Support System	Traditional Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Period Title: Overall Study
STARTED	225	485
COMPLETED	171	401
NOT COMPLETED	54	84

Baseline Characteristics

Arm/Group Title	Uphold Lightweight Vaginal Support System	Traditional Native Tissue Repair	Total
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy	Total of all reporting groups
Overall Participants	225	485	710
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	66.1 (10.8)	61.8 (10.5)	63.2 (10.8)
Sex: Female, Male (Count of Participants)
Female	225 100%	485 100%	710 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 2.7%	20 4.1%	26 3.7%
Not Hispanic or Latino	219 97.3%	457 94.2%	676 95.2%
Unknown or Not Reported	0 0%	8 1.6%	8 1.1%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
White	210 93.3%	409 84.3%	619 87.2%
Asian	5 2.2%	11 2.3%	16 2.3%
Black or African American	9 4%	55 11.3%	64 9%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.2%	1 0.1%
Other	1 0.4%	6 1.2%	7 1%
Not disclosed	0 0%	3 0.6%	3 0.4%
Region of Enrollment (participants) [Number]
United States	225 100%	485 100%	710 100%
Smoking (Count of Participants)
Current	18 8%	38 7.8%	56 7.9%
Previous	59 26.2%	139 28.7%	198 27.9%
Never	147 65.3%	308 63.5%	455 64.1%
Not Recorded	1 0.4%	0 0%	1 0.1%
Diabetes (Count of Participants)
Count of Participants [Participants]	32 14.2%	63 13%	95 13.4%
Menopausal Status (Count of Participants)
Premenopausal	11 4.9%	54 11.1%	65 9.2%
Perimenopausal	5 2.2%	27 5.6%	32 4.5%
Postmenopausal	209 92.9%	404 83.3%	613 86.3%
Previous Pelvic Surgery (Count of Participants)
Count of Participants [Participants]	169 75.1%	235 48.5%	404 56.9%

Outcome Measures

1. Primary Outcome

Title	Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Description	Success based on a composite of objective and subjective measures: 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. 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). 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).
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold Lightweight Vaginal Support System	Traditional Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	225	485
Intent to Treat Analysis	201 89.3%	389 80.2%
Per Protocol	199 88.4%	384 79.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Uphold Lightweight Vaginal Support System, Traditional Native Tissue Repair
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.056
	Comments	Statistical significance is considered at 0.05 level.
	Method	Z statistics
	Comments	P-value is calculated using a Z statistics from the propensity score adjusted estimates. Missing values are handled using multiple imputation.
Method of Estimation	Estimation Parameter	Adjusted difference in percentages
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 90%; -0.2 to 13.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months
Description	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
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold Lightweight Vaginal Support System	Traditional Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	225	485
Intent To Treat Analysis	7 3.1%	13 2.7%
Per Protocol	7 3.1%	12 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Uphold Lightweight Vaginal Support System, Traditional Native Tissue Repair
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	With type I error of 0.05 and type II error of 0.20 (power 80%), 298 subjects (149 subjects per arm) are needed to detect non-inferiority with a margin of 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference in percentages
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 90%; -2.7 to 1.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	The propensity score adjusted difference in SAE rate of Uphold LITE transvaginal mesh (TVM) vs. NTR was estimated.

3. Secondary Outcome

Title	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Description	Provides a summary of the number of subjects who reported mesh erosion or exposure at each of the study follow-up time points.
Time Frame	6 Month, 12 Months, 18 Months, 24 Months, 36 Months, Overall

Outcome Measure Data

Analysis Population Description

The population includes the 225 subjects in the Transvaginal repair with mesh (Uphold LITE) 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	225	225	225	225
Erosion : Within 6 Months	0 0%	0 0%	0 0%	0 NaN
Erosion : Within 12 Months	0 0%	0 0%	0 0%	0 NaN
Erosion : Within 18 Months	0 0%	0 0%	0 0%	0 NaN
Erosion : Within 24 Months	0 0%	0 0%	0 0%	0 NaN
Erosion : Within 36 Months	0 0%	0 0%	0 0%	0 NaN
Erosion : Overall	0 0%	0 0%	0 0%	0 NaN
Exposure : Within 6 Months	3 1.3%	2 0.4%	1 0.1%	0 NaN
Exposure : Within 12 Months	5 2.2%	4 0.8%	1 0.1%	0 NaN
Exposure : Within 18 Months	7 3.1%	5 1%	2 0.3%	0 NaN
Exposure : Within 24 Months	8 3.6%	6 1.2%	2 0.3%	0 NaN
Exposure : Within 36 Months	9 4%	7 1.4%	2 0.3%	0 NaN
Exposure : Overall	11 4.9%	8 1.6%	3 0.4%	0 NaN

4. Secondary Outcome

Title	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Description	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.
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold Lightweight Vaginal Support System	Traditional Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	225	485
De novo Dyspareunia : Intent-to-treat	2 0.9%	6 1.2%
De novo Dyspareunia : As treated	2 0.9%	6 1.2%
Pelvic Pain : Intent-to-treat	11 4.9%	28 5.8%
Pelvic Pain : As treated	11 4.9%	28 5.8%
Infection : Intent-to-treat	23 10.2%	68 14%
Infection : As treated	23 10.2%	68 14%
Vaginal Shortening : Intent-to-treat	1 0.4%	0 0%
Vaginal Shortening : As treated	1 0.4%	0 0%
Atypical Vaginal Discharge : Intent-to-treat	2 0.9%	3 0.6%
Atypical Vaginal Discharge : As treated	2 0.9%	3 0.6%
Neuromuscular Problems : Intent-to-treat	10 4.4%	14 2.9%
Neuromuscular Problems : As treated	10 4.4%	14 2.9%
Vaginal Scarring : Intent-to-treat	0 0%	1 0.2%
Vaginal Scarring : As treated	0 0%	1 0.2%
De novo Vaginal Bleeding : Intent-to-treat	0 0%	7 1.4%
De novo Vaginal Bleeding : As treated	0 0%	7 1.4%
Fistula Formation : Intent-to-treat	0 0%	0 0%
Fistula Formation : As treated	0 0%	0 0%
De novo Voiding Dysfunction : Intent-to-treat	17 7.6%	23 4.7%
De novo Voiding Dysfunction : As treated	17 7.6%	23 4.7%

5. Secondary Outcome

Title	Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
Description	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.
Time Frame	6 Month, 12 Months, 18 Months, 24 Months, 36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold LITE	Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	225	485
6 Months	-78.9 (57.3)	-77.7 (53.2)
12 Months	-74.8 (61.6)	-76.9 (54.2)
18 Months	-78.5 (60.9)	-77.3 (53.4)
24 Months	-81.8 (56.6)	-77.5 (53.9)
36 Months	-73.5 (59.4)	-77.2 (56.1)

6. Secondary Outcome

Title	Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
Description	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.
Time Frame	6 Month, 12 Months, 18 Months, 24 Months, 36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold LITE	Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	222	485
6 Months	-51.2 (59.2)	-41.0 (56.1)
12 Months	-47.7 (66.6)	-41.9 (55.8)
18 Months	-48.8 (66.4)	-42.9 (58.8)
24 Months	-50.3 (62.9)	-41.5 (57.6)
36 Months	-48.1 (62.9)	-41.9 (55.0)

7. Secondary Outcome

Title	Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
Description	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.
Time Frame	6 Month, 12 Months, 18 Months, 24 Months, 36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold LITE	Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	90	234
6 Month	4.4 (6.2)	4.4 (6.3)
12 Month	3.9 (6.4)	4.4 (6.3)
18 Month	4.1 (5.7)	4.0 (6.2)
24 Month	4.0 (6.2)	4.6 (6.5)
36 Month	4.2 (5.8)	4.3 (5.8)

8. Secondary Outcome

Title	Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects
Description	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.
Time Frame	6 Month, 12 Months, 18 Months, 24 Months, 36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold LITE	Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	225	485
6 Months	-3.8 (8.1)	-3.3 (8.3)
12 Months	-3.4 (8.3)	-3.8 (8.7)
18 Months	-3.5 (10.6)	-4.2 (9.0)
24 Months	-3.6 (8.8)	-3.9 (9.1)
36 Months	-4.3 (8.7)	-4.0 (8.3)

9. Secondary Outcome

Title	Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
Description	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.
Time Frame	6 Month, 12 Months, 18 Months, 24 Months, 36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold LITE	Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	225	485
6 Month	1.4 (0.7)	1.3 (0.7)
12 Month	1.5 (0.9)	1.4 (0.9)
18 Month	1.4 (0.8)	1.4 (0.9)
24 Month	1.4 (0.9)	1.4 (0.9)
36 Month	1.6 (1.0)	1.4 (0.9)

10. Secondary Outcome

Title	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Description	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.
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold LITE	Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	225	485
Office-based Intervention for Recurrence : Intent-to-Treat	1 0.4%	2 0.4%
Office-based Intervention for Recurrence : As Treated	1 0.4%	2 0.4%
Surgical Intervention for Recurrence : Intent-to-Treat	5 2.2%	15 3.1%
Surgical Intervention for Recurrence : As Treated	5 2.2%	15 3.1%
Office-based Intervention for Complications : Intent-to-Treat	13 5.8%	40 8.2%
Office-based Intervention for Complications : As Treated	13 5.8%	40 8.2%
Surgical Intervention for Complications : Intent-to-Treat	20 8.9%	34 7%
Surgical Intervention for Complications : As Treated	20 8.9%	34 7%

11. Secondary Outcome

Title	Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Description	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).
Time Frame	36 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Uphold Lightweight Vaginal Support System	Traditional Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Measure Participants	225	485
Intent to treat	188 83.6%	353 72.8%
Per protocol	185 82.2%	346 71.3%

Adverse Events

Time Frame	36 Months
Arm/Group Title	Uphold Lightweight Vaginal Support System		Traditional Native Tissue Repair
Arm/Group Description	Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)		Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
All Cause Mortality
	Uphold Lightweight Vaginal Support System		Traditional Native Tissue Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/225 (1.3%)		2/485 (0.4%)
Serious Adverse Events
	Uphold Lightweight Vaginal Support System		Traditional Native Tissue Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/225 (5.3%)		27/485 (5.6%)
Cardiac disorders
Cardiac Event- New	0/225 (0%)	0	6/485 (1.2%)	6
Cardiac Event- Worsening	0/225 (0%)	0	1/485 (0.2%)	1
Gastrointestinal disorders
Constipation - Worsening	0/225 (0%)	0	1/485 (0.2%)	1
Ileus / Bowel Obstruction	0/225 (0%)	0	4/485 (0.8%)	4
Other, Specify	0/225 (0%)	0	1/485 (0.2%)	1
General disorders
Death	2/225 (0.9%)	2	0/485 (0%)	0
Fever	1/225 (0.4%)	1	0/485 (0%)	0
Infection- Other, Specify Type	1/225 (0.4%)	1	0/485 (0%)	0
Infections and infestations
Infection - Other, specify type	0/225 (0%)	0	4/485 (0.8%)	6
Pelvic Infection / Abscess	0/225 (0%)	0	2/485 (0.4%)	2
Pulmonary Event, Specify - NEW	0/225 (0%)	0	1/485 (0.2%)	1
Urinary Tract Infection (UTI), Lower	0/225 (0%)	0	2/485 (0.4%)	2
Injury, poisoning and procedural complications
Ureteral Kink / Injury	1/225 (0.4%)	1	2/485 (0.4%)	2
Visceral Organ Injury	0/225 (0%)	0	1/485 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, Specify	0/225 (0%)	0	1/485 (0.2%)	1
Product Issues
Mesh Exposure in Vagina	1/225 (0.4%)	1	0/485 (0%)	0
Renal and urinary disorders
Hematoma - Retropubic	0/225 (0%)	0	1/485 (0.2%)	1
Mixed Incontinence	1/225 (0.4%)	1	0/485 (0%)	0
Reproductive system and breast disorders
Pelvic Pain - NEW	0/225 (0%)	0	1/485 (0.2%)	1
Prolapse	2/225 (0.9%)	2	0/485 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary Event, Specify - Worsening	0/225 (0%)	0	1/485 (0.2%)	2
Surgical and medical procedures
Other, Specify	0/225 (0%)	0	1/485 (0.2%)	1
Vascular disorders
Bleeding	1/225 (0.4%)	1	0/485 (0%)	0
Bleeding Requiring Blood Transfusion	1/225 (0.4%)	1	0/485 (0%)	0
Malignant Hypertension	1/225 (0.4%)	1	0/485 (0%)	0
Thrombotic Event	0/225 (0%)	0	1/485 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Uphold Lightweight Vaginal Support System		Traditional Native Tissue Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	108/225 (48%)		312/485 (64.3%)
Cardiac disorders
Cardiac Event - NEW	0/225 (0%)	0	1/485 (0.2%)	1
Cardiac Worsening	0/225 (0%)	0	1/485 (0.2%)	1
Gastrointestinal disorders
Constipation - NEW	4/225 (1.8%)	4	12/485 (2.5%)	12
Constipation - Worsening	2/225 (0.9%)	2	5/485 (1%)	5
Fecal Incontinence - NEW	0/225 (0%)	0	18/485 (3.7%)	18
Fecal Incontinence - Worsening	0/225 (0%)	0	6/485 (1.2%)	6
Hematoma - Retroperitoneal	2/225 (0.9%)	2	1/485 (0.2%)	1
Hemorrhoids	0/225 (0%)	0	3/485 (0.6%)	3
Ileus / Bowel Obstruction	0/225 (0%)	0	1/485 (0.2%)	1
Nausea	2/225 (0.9%)	2	0/485 (0%)	0
Neuromuscular Disorder, specify type	0/225 (0%)	0	8/485 (1.6%)	8
Other, Specify	1/225 (0.4%)	1	7/485 (1.4%)	7
General disorders
Inflammation	1/225 (0.4%)	1	1/485 (0.2%)	1
Neuromuscular Disorder, specify type	0/225 (0%)	0	1/485 (0.2%)	1
Other, Specify	1/225 (0.4%)	1	2/485 (0.4%)	2
Pain, Other	5/225 (2.2%)	5	3/485 (0.6%)	3
Infections and infestations
Infection - Other, specify type	4/225 (1.8%)	4	9/485 (1.9%)	10
Other, Specify	0/225 (0%)	0	1/485 (0.2%)	1
Pelvic Infection / Abscess	2/225 (0.9%)	2	3/485 (0.6%)	3
Pulmonary Event, Specify - NEW	0/225 (0%)	0	2/485 (0.4%)	2
Upper Respiratory Infection	0/225 (0%)	0	1/485 (0.2%)	1
Urinary Tract Infection (UTI), Lower	31/225 (13.8%)	43	118/485 (24.3%)	164
Vaginal Infection	4/225 (1.8%)	4	16/485 (3.3%)	18
Injury, poisoning and procedural complications
Fracture	0/225 (0%)	0	1/485 (0.2%)	2
Other, Specify	0/225 (0%)	0	3/485 (0.6%)	3
Visceral Organ Injury	0/225 (0%)	0	2/485 (0.4%)	2
Musculoskeletal and connective tissue disorders
Buttock Pain	4/225 (1.8%)	4	2/485 (0.4%)	2
Neuromuscular Disorder, specify type	2/225 (0.9%)	2	1/485 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasia, Non-Pelvic	0/225 (0%)	0	1/485 (0.2%)	1
Nervous system disorders
Neuromuscular Disorder, specify type	9/225 (4%)	9	6/485 (1.2%)	6
Neurovascular Event	0/225 (0%)	0	1/485 (0.2%)	1
Product Issues
Mesh Exposure in Vagina	10/225 (4.4%)	12	0/485 (0%)	0
Suture Exposure in Vagina	0/225 (0%)	0	19/485 (3.9%)	20
Renal and urinary disorders
Difficulty Emptying Bladder - NEW	13/225 (5.8%)	13	24/485 (4.9%)	25
Difficulty Emptying Bladder - Worsening	1/225 (0.4%)	1	4/485 (0.8%)	4
Dysuria	1/225 (0.4%)	1	4/485 (0.8%)	7
Mixed Incontinence- Worsening	1/225 (0.4%)	1	0/485 (0%)	0
Mixed Urinary Incontinence	0/225 (0%)	0	1/485 (0.2%)	1
Other, Specify	1/225 (0.4%)	1	5/485 (1%)	5
Overactive Bladder	5/225 (2.2%)	5	6/485 (1.2%)	6
Stress Incontinence - NEW	7/225 (3.1%)	7	6/485 (1.2%)	6
Stress Incontinence - Worsening	3/225 (1.3%)	3	21/485 (4.3%)	21
Urge Incontinence - NEW	8/225 (3.6%)	8	8/485 (1.6%)	8
Urge Incontinence - Worsening	1/225 (0.4%)	1	25/485 (5.2%)	26
Urinary Frequency	1/225 (0.4%)	1	6/485 (1.2%)	6
Urinary Urgency	2/225 (0.9%)	2	5/485 (1%)	5
Weak Urinary Stream	0/225 (0%)	0	1/485 (0.2%)	1
Reproductive system and breast disorders
Dyspareunia - NEW (De Novo)	3/225 (1.3%)	3	11/485 (2.3%)	11
Dyspareunia - Worsening	0/225 (0%)	0	3/485 (0.6%)	3
Hematoma - Vaginal	1/225 (0.4%)	1	1/485 (0.2%)	1
Other, Specify	2/225 (0.9%)	2	4/485 (0.8%)	4
Pelvic Pain - New	14/225 (6.2%)	14	39/485 (8%)	41
Pelvic Pain - Worsening	1/225 (0.4%)	1	2/485 (0.4%)	2
Prolapse	20/225 (8.9%)	20	88/485 (18.1%)	93
Sensation Of Bulge	26/225 (11.6%)	27	53/485 (10.9%)	55
Sensation Of Pressure	0/225 (0%)	0	1/485 (0.2%)	1
Vaginal Atrophy	0/225 (0%)	0	3/485 (0.6%)	3
Vaginal Bleeding, De Novo	0/225 (0%)	0	9/485 (1.9%)	10
Vaginal Discharge, Atypical	2/225 (0.9%)	2	3/485 (0.6%)	3
Vaginal Scarring	0/225 (0%)	0	2/485 (0.4%)	2
Vaginal Shortening	1/225 (0.4%)	1	0/485 (0%)	0
Vaginal Wall Dehiscence	0/225 (0%)	0	1/485 (0.2%)	1
Vulvar Itching	0/225 (0%)	0	1/485 (0.2%)	1
Vulvar Lesion	0/225 (0%)	0	1/485 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Other, Specify	0/225 (0%)	0	1/485 (0.2%)	1
Skin and subcutaneous tissue disorders
Lichen Sclerosus	0/225 (0%)	0	1/485 (0.2%)	1
Rash	0/225 (0%)	0	1/485 (0.2%)	1
Skin Condition	0/225 (0%)	0	1/485 (0.2%)	1
Tissue Granulation	2/225 (0.9%)	2	33/485 (6.8%)	33
Vascular disorders
Bleeding	0/225 (0%)	0	1/485 (0.2%)	1
Hematoma - Other	0/225 (0%)	0	1/485 (0.2%)	1
Other, Specify	0/225 (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.