Clinical Trial: Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Karolinska Institutet

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: March 28, 2013
Date Started: January 2012
Date Completion:
Last Updated: April 2, 2013
Last Verified: March 2013