Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

NCT02921451 | Unknown

• 1 other identifier: IISP 16-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Prolapse

Outcome Measures

Primary Outcomes (1)

• 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.

  Within first two years after surgical procedure

Study Arms (1)

Restorelle Smartmesh

OTHER

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

Device: Restorelle Smartmesh

Interventions

Restorelle Smartmesh DEVICE

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

Restorelle Smartmesh

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (1)

Advanced Urogynecology of Michigan, P.C.

Dearborn, Michigan, 48125, United States

Location

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Salil Khandwala

  Advanced Urogynecology of Michigan, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 3, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)