Uphold LITE Post-Market Surveillance Study

NCT01917968 | Completed Results

• 1 other identifier: U8090
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 28

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.

Conditions

Pelvic Organ Prolapse

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

  36 Months

• 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

  36 months

Secondary Outcomes (9)

• 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

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

  36 Months

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

  6 Month, 12 Months, 18 Months, 24 Months, 36 Months

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

  6 Month, 12 Months, 18 Months, 24 Months, 36 Months

• Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects

  6 Month, 12 Months, 18 Months, 24 Months, 36 Months

Study Arms (2)

Uphold Lightweight Vaginal Support System

ACTIVE COMPARATOR

Transvaginal repair with mesh (Uphold LITE)

Device: Uphold Lightweight Vaginal Support System

Traditional native tissue repair

ACTIVE COMPARATOR

Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Procedure: Traditional native tissue repair

Interventions

Uphold Lightweight Vaginal Support System DEVICE

Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)

Also known as: Uphold LITE

Uphold Lightweight Vaginal Support System

Traditional native tissue repair PROCEDURE

Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Traditional native tissue repair

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (28)

University of Alabama at Birmingham Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

Montgomery Women's Health Associates, PC

Montgomery, Alabama, 36117, United States

Location

UCSD Health/Women's Pelvic Medicine Center

La Jolla, California, 92037, United States

Location

Sherry Thomas, PC

North Hollywood, California, 91301, United States

Location

University of CA Irvine Medical Center

Orange, California, 92868, United States

Location

Kaiser Permanente OB/GYN Urogynecology

San Diego, California, 92110, United States

Location

Scripps Clinic Carmel Valley

San Diego, California, 92130, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

The Florida Bladder Institute

Naples, Florida, 34109, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Capital Women's Care - Frederick

Frederick, Maryland, 21702, United States

Location

Las Vegas Minimally Invasive Surgery Women's Pelvic Health Center

Las Vegas, Nevada, 89135, United States

Location

Cooper University Hospital

Voorhees Township, New Jersey, 08043, United States

Location

Columbia University Irving Medical Center/NY Presbyterian Hospital

New York, New York, 10032, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28210, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

St. Alexius Medical Center/Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States

Location

University of Cincinnati Physicians Co

Cincinnati, Ohio, 45267, United States

Location

Institute for Female Pelvic Medicine & Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Institute for Female Pelvic Medicine & Reconstructive Surgery

North Wales, Pennsylvania, 19454, United States

Location

Prisma Health System

Greenville, South Carolina, 29605, United States

Location

Holston Medical Group at Seasons Center for Urogynecology & Advanced Pelvic Surgery

Bristol, Tennessee, 37620, United States

Location

Dr. M. Mitchell Silver, FACOG, PA

Nacogdoches, Texas, 25965, United States

Location

Kyle P. McMorries, MD

Nacogdoches, Texas, 75965, United States

Location

Women's OB/GYN Center

Pasadena, Texas, 77505, United States

Location

MultiCare Women's Health Care

Covington, Washington, 98042, United States

Location

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

Location

Related Publications (1)

• Kahn B, Varner RE, Murphy M, Sand P, Thomas S, Lipetskaia L, Chung DE, Mahdy A, Noblett K. Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse. Obstet Gynecol. 2022 Jun 1;139(6):975-985. doi: 10.1097/AOG.0000000000004794. Epub 2022 May 2.

  PMID: 35675593 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Boston Scientific Corporation

teresa.takle-flach@bsci.com

952-930-6000

Study Officials

• Karen Noblett, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: August 7, 2013
• Study Start: October 10, 2013
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: May 20, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-04

Locations

US (28)