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Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT01823055
Collaborator
Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific (Other)
214
Enrollment
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transvaginal suture capturing mesh device
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
214 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Surgery

Transvaginal suture capturing mesh device

Procedure: Transvaginal suture capturing mesh device
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.
Other Names:
  • Uphold™ LITE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Immediate and delayed complications related to the surgical procedure [1 year]

      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

    1. Pelvic Organ Prolapse Quantification system [1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Karolinska Institutet
    • Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Altman, Md, PhD, Associate professor, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT01823055
    Other Study ID Numbers:
    • Karolinska Institutet
    First Posted:
    Apr 4, 2013
    Last Update Posted:
    Apr 4, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Cystocele
    Uterine Prolapse
    Prolapse

    Study Results

    No Results Posted as of Apr 4, 2013