Status:
COMPLETED
Uphold LITE Post-Market Surveillance Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-100 years
Phase:
NA
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 apic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2020
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT01917968
Start Date
October 10 2013
End Date
February 12 2020
Last Update
May 20 2021
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham Kirklin Clinic
Birmingham, Alabama, United States, 35233
2
Montgomery Women's Health Associates, PC
Montgomery, Alabama, United States, 36117
3
UCSD Health/Women's Pelvic Medicine Center
La Jolla, California, United States, 92037
4
Sherry Thomas, PC
North Hollywood, California, United States, 91301