Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

Sponsor
Michigan Institution of Women's Health PC (Other)
Overall Status
Unknown status
CT.gov ID
NCT02921451
Collaborator
Coloplast A/S (Industry)
40
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48
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Restorelle Smartmesh
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Restorelle Smartmesh

Surgical procedure for treatment of uterine prolapse will use the device, Restorelle Smartmesh.

Device: Restorelle Smartmesh
Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Advanced Urogynecology of Michigan, P.C. Dearborn Michigan United States 48125

Sponsors and Collaborators

  • Michigan Institution of Women's Health PC
  • Coloplast A/S

Investigators

  • Principal Investigator: Salil Khandwala, Advanced Urogynecology of Michigan, P.C.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Salil Khandwala, Medical Director, Michigan Institution of Women's Health PC
ClinicalTrials.gov Identifier:
NCT02921451
Other Study ID Numbers:
  • IISP 16-05
First Posted:
Oct 3, 2016
Last Update Posted:
Aug 14, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2019