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Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

Primary Purpose

Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transvaginal suture capturing mesh device
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification [POP-Q] system)9,
  • with or without anterior vaginal wall prolapse, and
  • experiences symptoms of vaginal bulging with or without a previous hysterectomy
  • being able to provide oral and written informed consent before entering the study.

Exclusion Criteria:

  • previous cancer of any pelvic organ,
  • systemic glucocorticoid treatment,
  • insulin-treated diabetes,
  • an inability to participate in study follow-up or to provide informed consent, or
  • the need for any concomitant pelvic surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Surgery

    Arm Description

    Transvaginal suture capturing mesh device

    Outcomes

    Primary Outcome Measures

    Immediate and delayed complications related to the surgical procedure
    Serious surgical complications are categorised as any surgical event which is potentially life-threatening, internal organ perforation (or other injury), bleeding in excess of 1000 mL or adverse events, related to the surgical procedure, during follow-up which requires re-hospitalisation.

    Secondary Outcome Measures

    Pelvic Organ Prolapse Quantification system
    The secondary efficacy outcome is a composite of objective and subjective measures including POP-Q stage 0 or 1 of the upper vaginal segment (i.e., point C/D, which represents the most distal point of the vaginal apex in relation to the total vaginal length) and a negative response to the question, "Do you experience a feeling of bulging or protrusion in the vaginal area?" (question 16 on the UDI). The secondary outcome measures further include the individual components of the composite end point, other POP-Q measurements and patient-reported urogenital distress.

    Full Information

    First Posted
    March 28, 2013
    Last Updated
    April 2, 2013
    Sponsor
    Karolinska Institutet
    Collaborators
    Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01823055
    Brief Title
    Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
    Official Title
    Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet
    Collaborators
    Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    214 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgery
    Arm Type
    Experimental
    Arm Description
    Transvaginal suture capturing mesh device
    Intervention Type
    Procedure
    Intervention Name(s)
    Transvaginal suture capturing mesh device
    Other Intervention Name(s)
    Uphold™ LITE
    Intervention Description
    The Uphold™ LITE vaginal support system is an intra-vaginal approach to apical and anterior vaginal wall prolapse repair that utilizes a suture capturing device to place the mesh. After primary dissection the suturing device is used to pull the mesh through the sacrospinous ligament, medial to the ischial spine. An anterior colporraphy was allowed following the Uphold™ LITE procedure at the discretion of the surgeon if deemed necessary.
    Primary Outcome Measure Information:
    Title
    Immediate and delayed complications related to the surgical procedure
    Description
    Serious surgical complications are categorised as any surgical event which is potentially life-threatening, internal organ perforation (or other injury), bleeding in excess of 1000 mL or adverse events, related to the surgical procedure, during follow-up which requires re-hospitalisation.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Pelvic Organ Prolapse Quantification system
    Description
    The secondary efficacy outcome is a composite of objective and subjective measures including POP-Q stage 0 or 1 of the upper vaginal segment (i.e., point C/D, which represents the most distal point of the vaginal apex in relation to the total vaginal length) and a negative response to the question, "Do you experience a feeling of bulging or protrusion in the vaginal area?" (question 16 on the UDI). The secondary outcome measures further include the individual components of the composite end point, other POP-Q measurements and patient-reported urogenital distress.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification [POP-Q] system)9, with or without anterior vaginal wall prolapse, and experiences symptoms of vaginal bulging with or without a previous hysterectomy being able to provide oral and written informed consent before entering the study. Exclusion Criteria: previous cancer of any pelvic organ, systemic glucocorticoid treatment, insulin-treated diabetes, an inability to participate in study follow-up or to provide informed consent, or the need for any concomitant pelvic surgery.

    12. IPD Sharing Statement

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    Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

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