Clinical trial NCT01917968: Uphold LITE Post-Market Surveillance Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: POP
Transvaginal
Native Tissue Repair
Repair Augmented with Mesh
Pelvic Organ Prolapse
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 289
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
timeFrame: 36 Months
measure: Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months
timeFrame: 36 months
Secondary outcomes:
measure: Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
timeFrame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months, Overall
measure: Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
timeFrame: 36 Months
measure: Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
timeFrame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
measure: Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
timeFrame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
measure: Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
timeFrame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
measure: Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects
timeFrame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
measure: Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
timeFrame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months
measure: Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
timeFrame: 36 Months
measure: Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
timeFrame: 36 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Kirklin Clinic
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Women's Health Associates, PC
state: Alabama
city: La Jolla
country: United States
facility: UCSD Health/Women's Pelvic Medicine Center
state: California
city: North Hollywood
country: United States
facility: Sherry Thomas, PC
state: California
city: Orange
country: United States
facility: University of CA Irvine Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente OB/GYN Urogynecology
state: California
city: San Diego
country: United States
facility: Scripps Clinic Carmel Valley
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Naples
country: United States
facility: The Florida Bladder Institute
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Frederick
country: United States
facility: Capital Women's Care - Frederick
state: Maryland
city: Las Vegas
country: United States
facility: Las Vegas Minimally Invasive Surgery Women's Pelvic Health Center
state: Nevada
city: Voorhees
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center/NY Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Bismarck
country: United States
facility: St. Alexius Medical Center/Mid Dakota Clinic
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Co
state: Ohio
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine & Reconstructive Surgery
state: Pennsylvania
city: North Wales
country: United States
facility: Institute for Female Pelvic Medicine & Reconstructive Surgery
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health System
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group at Seasons Center for Urogynecology & Advanced Pelvic Surgery
state: Tennessee
city: Nacogdoches
country: United States
facility: Dr. M. Mitchell Silver, FACOG, PA
state: Texas
city: Nacogdoches
country: United States
facility: Kyle P. McMorries, MD
state: Texas
city: Pasadena
country: United States
facility: Women's OB/GYN Center
state: Texas
city: Covington
country: United States
facility: MultiCare Women's Health Care
state: Washington
city: West Allis
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
Study officials:
affiliation: University of California, Irvine
name: Karen Noblett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.