Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

Karolinska Institute

Status: Completed

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

Treatments: Procedure: Transvaginal suture capturing mesh device

Study type: Interventional

Funder types: Other

Identifiers

NCT01823055

Karolinska Institutet

Details and patient eligibility

About

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

Enrollment: 214 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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214 participants in 1 patient group

Surgery

Experimental group

Description:

Transvaginal suture capturing mesh device

Treatment:

Procedure: Transvaginal suture capturing mesh device