Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

Not Applicable

Completed

• Conditions: Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
• Interventions: Procedure: Transvaginal suture capturing mesh device

• Registration Number: NCT01823055
• Lead Sponsor: Karolinska Institutet

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 Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Study First Posted: 2013-04-04
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 214

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Transvaginal suture capturing mesh device	Transvaginal suture capturing mesh device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.