Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery

Transvaginal suture capturing mesh device

Group Type EXPERIMENTAL

Transvaginal suture capturing mesh device

Intervention Type 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.

Interventions

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Transvaginal suture capturing mesh device

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.

Intervention Type PROCEDURE

Other Intervention Names

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Uphold™ LITE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No