Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

Michigan Institution of Women's Health PC

Status

Unknown

Conditions

Uterine Prolapse

Treatments

Device: Restorelle Smartmesh

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02921451

IISP 16-05

Details and patient eligibility

About

The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.

Full description

This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is female.
Subject is at least 18 years of age.
Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
Subject is willing to provide written informed consent.
Subject is willing and able to comply with follow-up regimen.

Exclusion criteria

Subject is pregnant or intends to become pregnant in the future.
Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
Subject has undergone any previous repair for pelvic organ prolapse.
Subject has undergone a hysterectomy.
Subject lacks competency of the English language.