N/A
N=710
Uphold LITE Post-Market Surveillance Study
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT01917968 ↗Enrolled (actual)
710
Serious AEs
5.5%
Results posted
Mar 2021
Primary outcome: Primary: Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months — 201; 389; 199; 384 Participants — p=0.056
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Uphold Lightweight Vaginal Support System (Device); Traditional native tissue repair (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months |
201; 389; 199; 384 | 0.056 |
| PRIMARY Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months |
7; 13; 7; 12 | — |
| SECONDARY Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events |
2; 6; 2; 6; 11; 28 | — |
| SECONDARY Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects |
-78.9; -77.7; -74.8; -76.9; -78.5; -77.3 | — |
| SECONDARY Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects |
-51.2; -41.0; -47.7; -41.9; -48.8; -42.9 | — |
| SECONDARY Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects |
4.4; 4.4; 3.9; 4.4; 4.1; 4.0 | — |
| SECONDARY Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects |
-3.8; -3.3; -3.4; -3.8; -3.5; -4.2 | — |
| SECONDARY Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects |
1.4; 1.3; 1.5; 1.4; 1.4; 1.4 | — |
| SECONDARY Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure |
1; 2; 1; 2; 5; 15 | — |
| SECONDARY Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months |
188; 353; 185; 346 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01917968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.