Uphold LITE Post-Market Surveillance Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01917968

Acronym

Uphold LITE

Enrollment

289

Registered

2013-08-07

Start date

2013-10-10

Completion date

2020-02-12

Last updated

2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

POP, Transvaginal, Native Tissue Repair, Repair Augmented with Mesh, Pelvic Organ Prolapse

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.

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.

Interventions

DEVICEUphold Lightweight Vaginal Support System

Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)

PROCEDURETraditional native tissue repair

Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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: 1. Objective success was achieved by the subject having an anatomic outcome defined as the leading edge of prolapse at or above the hymen in the operated compartment: * Anterior segment: Leading edge of anterior prolapse was at or above the hymen or POP-Q point Ba ≤ 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. 2. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering no or yes but Not at all bothersome (\< 2). 3. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery (i.e., 'treated segment' refers to the target compartment).
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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).
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.
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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
Uphold Lightweight Vaginal Support System Transvaginal repair with mesh (Uphold LITE) Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)	225
Traditional Native Tissue Repair Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy	485
Total	710

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	36M Missed Visit	3	2
Overall Study	Change in Family Circumstances	0	1
Overall Study	Death	3	2
Overall Study	Lost to Follow-up	21	39
Overall Study	No Data Available	0	2
Overall Study	Physician Decision	1	2
Overall Study	Subject Noncompliance to Scheduled 36M Follow Up Visit	1	0
Overall Study	Subject Relocation	5	1
Overall Study	Withdrawal by Subject	20	35

Baseline characteristics

Characteristic	Uphold Lightweight Vaginal Support System	Total	Traditional Native Tissue Repair
Age, Continuous	66.1 Years STANDARD_DEVIATION 10.8	63.2 Years STANDARD_DEVIATION 10.8	61.8 Years STANDARD_DEVIATION 10.5
Diabetes	32 Participants	95 Participants	63 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	26 Participants	20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	219 Participants	676 Participants	457 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	8 Participants	8 Participants
Menopausal Status Perimenopausal	5 Participants	32 Participants	27 Participants
Menopausal Status Postmenopausal	209 Participants	613 Participants	404 Participants
Menopausal Status Premenopausal	11 Participants	65 Participants	54 Participants
Previous Pelvic Surgery	169 Participants	404 Participants	235 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian	5 Participants	16 Participants	11 Participants
Race/Ethnicity, Customized Black or African American	9 Participants	64 Participants	55 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Not disclosed	0 Participants	3 Participants	3 Participants
Race/Ethnicity, Customized Other	1 Participants	7 Participants	6 Participants
Race/Ethnicity, Customized White	210 Participants	619 Participants	409 Participants
Region of Enrollment United States	225 participants	710 participants	485 participants
Sex: Female, Male Female	225 Participants	710 Participants	485 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Smoking Current	18 Participants	56 Participants	38 Participants
Smoking Never	147 Participants	455 Participants	308 Participants
Smoking Not Recorded	1 Participants	1 Participants	0 Participants
Smoking Previous	59 Participants	198 Participants	139 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	3 / 225	2 / 485
other Total, other adverse events	108 / 225	312 / 485
serious Total, serious adverse events	12 / 225	27 / 485

Outcome results

Primary

Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 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

Time frame: 36 months

Population: 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	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Uphold Lightweight Vaginal Support System	Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months	Intent To Treat Analysis	7 Participants
Uphold Lightweight Vaginal Support System	Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months	Per Protocol	7 Participants
Traditional Native Tissue Repair	Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months	Intent To Treat Analysis	13 Participants
Traditional Native Tissue Repair	Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months	Per Protocol	12 Participants

90% CI: [-2.7, 1.9]

Primary

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

Success based on a composite of objective and subjective measures: 1. Objective success was achieved by the subject having an anatomic outcome defined as the leading edge of prolapse at or above the hymen in the operated compartment: * Anterior segment: Leading edge of anterior prolapse was at or above the hymen or POP-Q point Ba ≤ 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. 2. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering no or yes but Not at all bothersome (\< 2). 3. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery (i.e., 'treated segment' refers to the target compartment).

Time frame: 36 Months

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Uphold Lightweight Vaginal Support System	Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months	Intent to Treat Analysis	201 Participants
Uphold Lightweight Vaginal Support System	Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months	Per Protocol	199 Participants
Traditional Native Tissue Repair	Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months	Intent to Treat Analysis	389 Participants
Traditional Native Tissue Repair	Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months	Per Protocol	384 Participants

p-value: 0.05690% CI: [-0.2, 13.2]Z statistics

Secondary

Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 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).

Time frame: 36 Months

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Uphold Lightweight Vaginal Support System	Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months	Intent to treat	188 Participants
Uphold Lightweight Vaginal Support System	Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months	Per protocol	185 Participants
Traditional Native Tissue Repair	Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months	Intent to treat	353 Participants
Traditional Native Tissue Repair	Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months	Per protocol	346 Participants

Secondary

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

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

Arm	Measure	Group	Value (NUMBER)
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Office-based Intervention for Recurrence : Intent-to-Treat	1 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Office-based Intervention for Recurrence : As Treated	1 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Surgical Intervention for Recurrence : Intent-to-Treat	5 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Surgical Intervention for Recurrence : As Treated	5 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Office-based Intervention for Complications : Intent-to-Treat	13 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Office-based Intervention for Complications : As Treated	13 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Surgical Intervention for Complications : Intent-to-Treat	20 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Surgical Intervention for Complications : As Treated	20 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Surgical Intervention for Complications : As Treated	34 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Office-based Intervention for Recurrence : Intent-to-Treat	2 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Office-based Intervention for Complications : Intent-to-Treat	40 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Office-based Intervention for Recurrence : As Treated	2 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Surgical Intervention for Complications : Intent-to-Treat	34 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Surgical Intervention for Recurrence : Intent-to-Treat	15 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Office-based Intervention for Complications : As Treated	40 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure	Surgical Intervention for Recurrence : As Treated	15 participants

Secondary

Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects

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

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

Arm	Measure	Group	Value (NUMBER)
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 6 Months	3 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Overall	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 24 Months	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 36 Months	9 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 36 Months	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 24 Months	8 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 12 Months	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 6 Months	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 18 Months	7 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 12 Months	5 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 18 Months	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Overall	11 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 36 Months	7 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 6 Months	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 12 Months	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 18 Months	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 24 Months	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 36 Months	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Overall	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 6 Months	2 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 12 Months	4 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 18 Months	5 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 24 Months	6 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Overall	8 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 6 Months	0 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 18 Months	0 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 6 Months	1 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 36 Months	2 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 12 Months	1 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 12 Months	0 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 18 Months	2 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Overall	3 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 24 Months	2 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 24 Months	0 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 36 Months	0 participants
Moderate	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Overall	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 36 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Overall	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 18 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 36 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 6 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 6 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 12 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 24 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 18 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Within 12 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Erosion : Within 24 Months	0 participants
Severe	Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects	Exposure : Overall	0 participants

Secondary

Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events

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

Arm	Measure	Group	Value (NUMBER)
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Dyspareunia : Intent-to-treat	2 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Dyspareunia : As treated	2 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Pelvic Pain : Intent-to-treat	11 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Pelvic Pain : As treated	11 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Infection : Intent-to-treat	23 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Infection : As treated	23 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Vaginal Shortening : Intent-to-treat	1 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Vaginal Shortening : As treated	1 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Atypical Vaginal Discharge : Intent-to-treat	2 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Atypical Vaginal Discharge : As treated	2 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Neuromuscular Problems : Intent-to-treat	10 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Neuromuscular Problems : As treated	10 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Vaginal Scarring : Intent-to-treat	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Vaginal Scarring : As treated	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Vaginal Bleeding : Intent-to-treat	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Vaginal Bleeding : As treated	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Fistula Formation : Intent-to-treat	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Fistula Formation : As treated	0 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Voiding Dysfunction : Intent-to-treat	17 participants
Uphold Lightweight Vaginal Support System	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Voiding Dysfunction : As treated	17 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Fistula Formation : As treated	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Dyspareunia : Intent-to-treat	6 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Neuromuscular Problems : Intent-to-treat	14 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Dyspareunia : As treated	6 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Vaginal Bleeding : As treated	7 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Pelvic Pain : Intent-to-treat	28 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Neuromuscular Problems : As treated	14 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Pelvic Pain : As treated	28 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Voiding Dysfunction : As treated	23 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Infection : Intent-to-treat	68 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Vaginal Scarring : Intent-to-treat	1 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Infection : As treated	68 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Fistula Formation : Intent-to-treat	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Vaginal Shortening : Intent-to-treat	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Vaginal Scarring : As treated	1 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Vaginal Shortening : As treated	0 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Voiding Dysfunction : Intent-to-treat	23 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Atypical Vaginal Discharge : Intent-to-treat	3 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	De novo Vaginal Bleeding : Intent-to-treat	7 participants
Traditional Native Tissue Repair	Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events	Atypical Vaginal Discharge : As treated	3 participants

Secondary

Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects

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.