Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

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

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

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.