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Uphold LITE Post-Market Surveillance Study (Uphold LITE)

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ClinicalTrials.gov Identifier: NCT01917968
Recruitment Status : Completed
First Posted : August 7, 2013
Results First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Device: Uphold Lightweight Vaginal Support System Procedure: Traditional native tissue repair Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2013
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : February 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Uphold Lightweight Vaginal Support System
Transvaginal repair with mesh (Uphold LITE)
Device: Uphold Lightweight Vaginal Support System
Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
Other Name: Uphold LITE

Active Comparator: Traditional native tissue repair
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Procedure: Traditional native tissue repair
Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy




Primary Outcome Measures :
  1. Primary Efficacy Endpoint - Composite Anatomic and Symptomatic Success at 36 Months [ Time Frame: 36 Months ]

    Success based on a composite of objective and subjective measures:

    1. Objective success was achieved by the subject having an anatomic outcome defined as the leading edge of prolapse at or above the hymen in the operated compartment:

      • Anterior segment: Leading edge of anterior prolapse was at or above the hymen or POP-Q point Ba ≤ 0.
      • Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C < -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse.
    2. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (< 2).
    3. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery (i.e., 'treated segment' refers to the target compartment).

  2. Co-Primary Safety Endpoint - Serious Device-Related and/or Procedure-Related Complications at 36 Months [ Time Frame: 36 months ]
    A co-primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Uphold LITE vs. NTR for safety by comparing the overall complication rate (device-related and/or procedure-related SAEs) at 36 months


Secondary Outcome Measures :
  1. Secondary Endpoint - Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects [ Time Frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months, Overall ]
    Provides a summary of the number of subjects who reported mesh erosion or exposure at each of the study follow-up time points.

  2. Secondary Endpoint - Device-Related and/or Procedure-Related Adverse Events [ Time Frame: 36 Months ]
    Incidence of the following device-related and/or procedure-related adverse events: de novo dyspareunia, pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation, and/or de novo voiding dysfunction.

  3. Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects [ Time Frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months ]
    The Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three components: Pelvic Organ Prolapse Distress Inventory (POPDI; 6 questions), Urinary Distress Inventory (UDI; 6 questions), and Colorectal-Anal Distress Inventory (CRADI; 8 questions). Each individual component score is summed. The total ranges from 0 to 300, with a higher score indicating a greater impact to QOL (i.e., distress symptoms are more noticeable) and a lower score indicating a lesser impact to QOL (i.e., distress symptoms are less noticeable). Reported outcomes are the change from Baseline for the time periods indicated.

  4. Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects [ Time Frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months ]
    The Pelvic Floor Impact Questionnaire (PFIQ-7) is composed of 3 separate but related assessments: the Urinary Impact Questionnaire, addresses the impact of urinary incontinence symptoms, the Colorectal-Anal Impact Questionnaire addresses the impact of colorectal-anal or bowel symptoms, and the Pelvic Organ Prolapse Impact Questionnaire addresses impact of vaginal and pelvic symptoms. For each question, the low score (0) corresponds to "not at all" and the high score (3) corresponds to "quite a bit". The scores for the UIQ-7, CRAIQ-7 and POPIQ-7 are additive to yield the final PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.

  5. Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects [ Time Frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months ]
    The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated short form that can be used to ascertain improvement in sexual function and desire in women undergoing therapy for pelvic organ prolapse. The PISQ-12 consists of 12 questions graded on a five-point Likert scale ranging from 0 (always) to 4 (never). There is a maximum score of 48 and a higher score indicates better sexual function. Reported outcomes are the change from Baseline for the time periods indicated.

  6. Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects [ Time Frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months ]
    The TOMUS Pain Score, a visual analog instrument with a scale of 0 (no pain sensation) to 10 (most intense pain sensation imaginable), was used to assess pain associated with surgery for pelvic organ prolapse. There are seven (7) questions each with a maximum score of 10 and a possible score range of 0-70. Reported outcomes are the change from Baseline for the time periods indicated.

  7. Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects [ Time Frame: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months ]
    The Patient Global Impression of Improvement (PGI-I) for prolapse symptoms is a validated QOL instrument that assesses patient perception of overall improvement after surgical interventions for pelvic organ prolapse. The scale is as follows: 1- Very much better; 2- Much better; 3- A little better; 4- No change; 5- A little worse; 6- Much worse; 7- Very much worse. Reported outcomes are the change from Baseline for the time periods indicated.

  8. Secondary Endpoint - Intervention for Recurrent Prolapse at 36 Months Post Index Procedure [ Time Frame: 36 Months ]
    Compares the office-based and surgical intervention for recurrent prolapse between the Uphold LITE arm and the NTR arm 36 months from the index procedure in the ITT and As Treated populations.

  9. Secondary Efficacy Endpoint - Composite Anatomic and Symptomatic Success at 36 Months [ Time Frame: 36 Months ]

    Secondary efficacy endpoint defined similarly to the primary efficacy endpoint except for the definition of objective success. Objective success for this endpoint is defined as:

    • Anatomic success in the operated compartment was achieved by:

      • Anterior segment: No anterior prolapse at or beyond the hymen or POP-Q point Ba < 0.
      • Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C < -1/2 TVL) for multi-compartment prolapse or POP-Q point C < 0 for single compartment apical prolapse.
    • Subjective success was achieved if the patient denied symptoms of vaginal bulging per PFDI-20 question 3, answering "no" or "yes" but "Not at all" bothersome (< 2).
    • No retreatment for POP: No additional surgical treatment for POP in segment(s) of the vagina treated at the index surgery or no pessary use since index surgery ('treated segment' refers to the target compartments in this study, which are the anterior and apical compartments).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917968


Locations
Show Show 28 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Karen Noblett, MD University of California, Irvine
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01917968    
Other Study ID Numbers: U8090
First Posted: August 7, 2013    Key Record Dates
Results First Posted: March 15, 2021
Last Update Posted: March 15, 2021
Last Verified: February 2021
Keywords provided by Boston Scientific Corporation:
POP
Transvaginal
Native Tissue Repair
Repair Augmented with Mesh
Pelvic Organ Prolapse
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical