Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

Status unconfirmed · Not applicable

Conditions studied: Uterine Prolapse

In brief

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

Key facts

Study ID

NCT02921451

Run by

Michigan Institution of Women's Health PC

People needed

40

Starts

2016-08-01

Expected to finish

2020-08-01

Last updated by the study team

2019-08-14

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Advanced Urogynecology of Michigan, P.C. — Dearborn, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.