Study Results
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View full resultsBasic Information
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COMPLETED
NA
289 participants
INTERVENTIONAL
2013-10-10
2020-02-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
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
Interventions
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Uphold Lightweight Vaginal Support System
Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
Traditional native tissue repair
Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
100 Years
FEMALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Noblett, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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University of Alabama at Birmingham Kirklin Clinic
Birmingham, Alabama, United States
Montgomery Women's Health Associates, PC
Montgomery, Alabama, United States
UCSD Health/Women's Pelvic Medicine Center
La Jolla, California, United States
Sherry Thomas, PC
North Hollywood, California, United States
University of CA Irvine Medical Center
Orange, California, United States
Kaiser Permanente OB/GYN Urogynecology
San Diego, California, United States
Scripps Clinic Carmel Valley
San Diego, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
The Florida Bladder Institute
Naples, Florida, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Capital Women's Care - Frederick
Frederick, Maryland, United States
Las Vegas Minimally Invasive Surgery Women's Pelvic Health Center
Las Vegas, Nevada, United States
Cooper University Hospital
Voorhees Township, New Jersey, United States
Columbia University Irving Medical Center/NY Presbyterian Hospital
New York, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
St. Alexius Medical Center/Mid Dakota Clinic
Bismarck, North Dakota, United States
University of Cincinnati Physicians Co
Cincinnati, Ohio, United States
Institute for Female Pelvic Medicine & Reconstructive Surgery
Allentown, Pennsylvania, United States
Institute for Female Pelvic Medicine & Reconstructive Surgery
North Wales, Pennsylvania, United States
Prisma Health System
Greenville, South Carolina, United States
Holston Medical Group at Seasons Center for Urogynecology & Advanced Pelvic Surgery
Bristol, Tennessee, United States
Dr. M. Mitchell Silver, FACOG, PA
Nacogdoches, Texas, United States
Kyle P. McMorries, MD
Nacogdoches, Texas, United States
Women's OB/GYN Center
Pasadena, Texas, United States
MultiCare Women's Health Care
Covington, Washington, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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U8090
Identifier Type: -
Identifier Source: org_study_id
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