Back to resultsProspective Analysis of Restorelle in the Treatment of Uterine Prolapse
Primary Purpose
Uterine Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restorelle Smartmesh
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Prolapse
Eligibility Criteria
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.
Sites / Locations
- Advanced Urogynecology of Michigan, P.C.
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Restorelle Smartmesh
Arm Description
Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.
Outcomes
Primary Outcome Measures
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02921451
First Posted
September 23, 2016
Last Updated
August 12, 2019
Sponsor
Michigan Institution of Women's Health PC
Collaborators
Coloplast A/S
1. Study Identification
Unique Protocol Identification Number
NCT02921451
Brief Title
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Official Title
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan Institution of Women's Health PC
Collaborators
Coloplast A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Restorelle Smartmesh
Arm Type
Other
Arm Description
Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.
Intervention Type
Device
Intervention Name(s)
Restorelle Smartmesh
Intervention Description
Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.
Primary Outcome Measure Information:
Title
Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
Description
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.
Time Frame
Within first two years after surgical procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salil Khandwala
Organizational Affiliation
Advanced Urogynecology of Michigan, P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Urogynecology of Michigan, P.C.
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48125
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
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