Uterine Prolapse
Conditions
Brief summary
The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.
Detailed 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.
Interventions
DEVICERestorelle Smartmesh
Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.
Sponsors
Coloplast A/S
Michigan Institution of Women's Health PC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is female. 2. Subject is at least 18 years of age. 3. Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh. 4. Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater. 5. 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). 6. Subject is willing to provide written informed consent. 7. Subject is willing and able to comply with follow-up regimen.
Exclusion criteria
1. Subject is pregnant or intends to become pregnant in the future. 2. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical). 3. Subject has undergone any previous repair for pelvic organ prolapse. 4. Subject has undergone a hysterectomy. 5. Subject lacks competency of the English language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria | Within first two years after surgical procedure | Success criteria will be defined through the examination of patient's Prolapse Quantification System Assessment (POPQ) score of C -1 or less and patient's report of bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 0 or 1 (i.e. response of not at all). Failure to meet this criteria will be considered recurrence of uterine prolapse. |
Countries
United States
Outcome results
None listed