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NCT Number: NCT01823055

Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

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

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Key information

Conditions

Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases Uterine Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transvaginal suture capturing mesh device

Procedure

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

Primary outcomes

  1. Immediate and delayed complications related to the surgical procedure

    Time frame: 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 outcomes

  1. Pelvic Organ Prolapse Quantification system

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

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

Registry information

Official study title

Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial

Important dates

Study start
2012
Primary completion
2013
First posted
Apr 4, 2013
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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