Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

NCT01378065 | Completed Results

• 1 other identifier: US011
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.

Conditions

Pelvic Organ Prolapse (POP)

Keywords

POP; pelvic organ prolapse; anterior prolapse; posterior prolapse; vaginal prolapse; vaginal floor reconstruction

Outcome Measures

Primary Outcomes (5)

• Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)

  Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  Baseline

• Palpability of the Restorelle Direct Fix A&P

  Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  6 weeks

• Palpability of the Restorelle Direct Fix A&P

  Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  3 months

• Palpability of the Restorelle Direct Fix A&P

  Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  6 months

• Palpability of the Restorelle Direct Fix A&P

  Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.

  12 months

Secondary Outcomes (29)

• Rates of de Novo Dyspareunia

  6 weeks

• Rates of de Novo Dyspareunia

  3 months

• Rates of de Novo Dyspareunia

  6 months

• Rates of de Novo Dyspareunia

  12 months

• Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks

  6 weeks

Interventions

Restorelle Direct Fix A&P DEVICE

Restorelle Direct Fix A\&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic organs into or out of the vaginal canal.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects satisfying criteria for inclusion in the study were enrolled.

You may qualify if:

• Adult female at least 18 years of age
• Willing and able to provide written informed consent
• Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as determined by Pelvic Organ Prolapse Quantification System (POP-Q) requiring surgical intervention in the anterior and/or posterior compartment
• Willing and able to complete all follow-up visits and procedures indicated in the protocol

You may not qualify if:

• Concurrent surgical treatment of pelvic organ prolapse using anything other than the Restorelle Direct Fix A\&P
• Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is not being repaired in the same procedure
• Previous pelvic organ prolapse repair using synthetic grafts
• Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of vaginal reconstruction
• Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty) at the time of vaginal reconstruction
• Pregnant or a desire to become pregnant
• Previous radiation or other treatments for cancer in the pelvic area
• Immunosuppression and/or current systemic steroid user
• On any anticoagulation therapy at the time of implant or with bleeding diathesis

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (6)

MedStar Health Research Institute at Baltimore

Baltimore, Maryland, 21237, United States

Location

Female Pelvic Medicine & Urogynecology Institute of MI

Grand Rapids, Michigan, 49503, United States

Location

Central Missouri Women's Healthcare

Marshall, Missouri, 65340, United States

Location

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

Location

The Group for Women

Norfolk, Virginia, 23502, United States

Location

Integrity Medical Research, LLC

Mountlake Terrace, Washington, 98043, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study N was small.

Results Point of Contact

• Title: Cathy Bartz
• Organization: Coloplast Corp

uscmba@coloplast.com

612-834-3127

Study Officials

• Barry Jarnagin, MD

  Center for Pelvic Health, Franklin, TN, United States

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 12, 2020
• Results First Posted: October 28, 2015

Record last verified: 2020-04

Locations

US (6)