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Uphold LITE Post-Market Surveillance Study (Uphold LITE)

Primary Purpose

Pelvic Organ Prolapse

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Uphold Lightweight Vaginal Support System

Traditional native tissue repair

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring POP, Transvaginal, Native Tissue Repair, Repair Augmented with Mesh, Pelvic Organ Prolapse

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Subject is female
Subject is ≥18 years of age
Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 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).
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")
Subject or subject's legally authorized representative must be willing to provide written informed consent
Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)
Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis polymyalgia rheumatica)
Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
Subject has a previous prolapse repair with mesh in the target compartment
Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
Subject is not able to conform to the modified dorsal lithotomy position
Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that includes the pelvis
Subject has uncontrolled diabetes mellitus (DM)
Subject is currently participating in or plans to participate in another device or drug study during this study
Subject has a known hypersensitivity to polypropylene mesh
Subject is pregnant or intends to become pregnant during the study

Sites / Locations

University of Alabama at Birmingham Kirklin Clinic
Montgomery Women's Health Associates, PC
UCSD Health/Women's Pelvic Medicine Center
Sherry Thomas, PC
University of CA Irvine Medical Center
Kaiser Permanente OB/GYN Urogynecology
Scripps Clinic Carmel Valley
MedStar Washington Hospital Center
The Florida Bladder Institute
NorthShore University HealthSystem
Regional Urology, LLC
Capital Women's Care - Frederick
Las Vegas Minimally Invasive Surgery Women's Pelvic Health Center
Cooper University Hospital
Columbia University Irving Medical Center/NY Presbyterian Hospital
Presbyterian Hospital
Lyndhurst Clinical Research
St. Alexius Medical Center/Mid Dakota Clinic
University of Cincinnati Physicians Co
Institute for Female Pelvic Medicine & Reconstructive Surgery
Institute for Female Pelvic Medicine & Reconstructive Surgery
Prisma Health System
Holston Medical Group at Seasons Center for Urogynecology & Advanced Pelvic Surgery
Dr. M. Mitchell Silver, FACOG, PA
Kyle P. McMorries, MD
Women's OB/GYN Center
MultiCare Women's Health Care
Aurora West Allis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Uphold Lightweight Vaginal Support System

Traditional native tissue repair

Arm Description

Transvaginal repair with mesh (Uphold LITE)

Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Outcomes

Primary Outcome Measures

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: 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).

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

Secondary Outcome Measures

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.

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.

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.

Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects

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

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 - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects

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: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects

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

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

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).

Full Information

NCT ID

NCT01917968

First Posted

July 18, 2013

Last Updated

April 29, 2021

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01917968

Brief Title

Uphold LITE Post-Market Surveillance Study

Acronym

Uphold LITE

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

October 10, 2013 (Actual)

Primary Completion Date

February 12, 2020 (Actual)

Study Completion Date

February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

289 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Uphold Lightweight Vaginal Support System

Arm Type

Active Comparator

Arm Description

Transvaginal repair with mesh (Uphold LITE)

Arm Title

Traditional native tissue repair

Arm Type

Active Comparator

Arm Description

Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Intervention Type

Device

Intervention Name(s)

Uphold Lightweight Vaginal Support System

Other Intervention Name(s)

Uphold LITE

Intervention Description

Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)

Intervention Type

Procedure

Intervention Name(s)

Traditional native tissue repair

Intervention Description

Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Primary Outcome Measure Information:

Title

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

Description

Time Frame

36 Months

Title

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

Description

Time Frame

36 months

Secondary Outcome Measure Information:

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

Title

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

Description

Time Frame

36 Months

Title

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

Description

Time Frame