Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse



Status:Active, not recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 100
Updated:3/7/2019
Start Date:October 2013
End Date:December 2019

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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

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.

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.

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
We found this trial at
28
sites
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Allentown, PA
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Birmingham, AL
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Bismarck, ND
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Bristol, TN
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200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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Charlotte, NC
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Cincinnati, OH
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27121 174th Place Southeast
Covington, Washington 98042
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Covington, WA
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Evanston, IL
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61 Thomas Johnson Drive
Frederick, Maryland 21702
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Frederick, MD
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Greenville, South Carolina 29605
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Greenville, SC
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La Jolla, California 92037
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La Jolla, CA
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Las Vegas, NV
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Montgomery, Alabama 36116
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Montgomery, AL
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Nacogdoches, Texas 75965
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Nacogdoches, TX
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Nacogdoches, Texas 25965
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Nacogdoches, TX
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Naples, Florida 34109
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Naples, FL
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from
New York, NY
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North Hollywood, California 91301
Principal Investigator: Sherry Thomas, MD
Phone: 818-991-0988
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North Hollywood, CA
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North Wales, PA
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Orange, California 92868
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Orange, CA
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5119 Fairmont Parkway
Pasadena, Texas 77505
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Pasadena, TX
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San Diego, California 92110
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San Diego, CA
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San Diego, California 92130
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San Diego, CA
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Shreveport, Louisiana 71106
Principal Investigator: Kevin Cline, MD
Phone: 318-683-0411
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Shreveport, LA
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Voorhees, New Jersey 08043
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Voorhees, NJ
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Washington, District of Columbia
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Washington,
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West Allis, Wisconsin 53227
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West Allis, WI
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Winston-Salem, North Carolina 27103
Principal Investigator: Bradley Jacobs, MD
Phone: 336-397-3723
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Winston-Salem, NC
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