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Xenform Postmarket Surveillance Study (Xenform)

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ClinicalTrials.gov Identifier: NCT01945580
Recruitment Status : Active, not recruiting
First Posted : September 18, 2013
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
Integra LifeSciences Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Procedure: Prolapse Repair

Detailed Description:

The primary objective is to evaluate clinical effectiveness of transvaginal repair with Xenform against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Xenform-related complications and subject reported outcomes.

The primary endpoint of the study is to achieve non-inferiority of transvaginal repair with Xenform over native tissue repair at 36 months as compared to baseline. Success will be based on a composite of objective and subjective measures.

Additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with Xenform to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point.

The secondary endpoints of the study include assessments of complications and subject reported outcomes.


Study Type : Observational [Patient Registry]
Actual Enrollment : 374 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: A Prospective, Non-Randomized, Parallel Cohort, Multi-Center Study of Xenform vs. Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse
Study Start Date : February 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Xenform
Prolapse Repair with Xenform Soft Tissue Repair Matrix
Procedure: Prolapse Repair
Transvaginal anterior/apical pelvic organ prolapse repair
Other Names:
  • Transvaginal
  • Prolapse
  • POP Repair
  • Anterior
  • Apical

Control
Prolapse Repair with Native Tissue Only
Procedure: Prolapse Repair
Transvaginal anterior/apical pelvic organ prolapse repair
Other Names:
  • Transvaginal
  • Prolapse
  • POP Repair
  • Anterior
  • Apical




Primary Outcome Measures :
  1. Surgical Success [ Time Frame: 36 Months ]
    Surgical success will be measured based on anatomic success measures (leading edge of prolapse is at or above the hymen and/or POPQ measurements), no additional surgical treatment for pelvic organ prolapse in the anterior/apical vaginal compartments, and patient denies symptoms of vaginal bulging (per PFDI-20 questionnaire).


Secondary Outcome Measures :
  1. Incidence of complications [ Time Frame: 36 Months ]
    Incidence of mesh erosion, mesh exposure, de novo dyspareunia, and the following device or procedure related events: pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation and/or de novo voiding dysfunction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with pelvic organ prolapse at or beyond the hymen who will be treated surgically.
Criteria

Inclusion Criteria:

  • Subject is female
  • Subject is at least 18 years of age
  • Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 (for prolapse of the anterior compartment alone) or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments).
  • Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
  • Subject or subject's legally authorized representative is willing to provide written informed consent
  • Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

  • Subject is pregnant or intends to become pregnant during the study
  • Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
  • Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
  • Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
  • Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
  • Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis, polymyalgia rheumatica)
  • Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
  • Subject has uncontrolled diabetes mellitus (DM)
  • Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
  • Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
  • Subject is not able to conform to the modified dorsal lithotomy position
  • Subject is currently participating in or plans to participate in another device or drug study during this study
  • Subject has a known sensitivity to any Xenform component
  • Subject has had previous prolapse repair with mesh in the target compartment
  • Subject is planning to undergo a concomitant prolapse repair with use of mesh in the non-target compartment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945580


  Hide Study Locations
Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
United States, Georgia
Emory Hospital
Atlanta, Georgia, United States, 30322
Augusta University
Augusta, Georgia, United States, 30912
Cherokee Womens Health
Canton, Georgia, United States, 30114
United States, Illinois
NorthShore University Health System
Skokie, Illinois, United States, 60076
United States, Louisiana
American Legion Hospital
Crowley, Louisiana, United States, 70526
United States, Maryland
Chesapeake Urology Research Associates
Glen Burnie, Maryland, United States, 21061
Chesapeake Urology Research Associates
Owings Mills, Maryland, United States, 21117
United States, Massachusetts
Boston Urogynecology Associates
Cambridge, Massachusetts, United States, 02138
United States, Michigan
Beyer Research
Kalamazoo, Michigan, United States, 49009
United States, New Jersey
Cooper Health
Voorhees, New Jersey, United States, 08043
United States, New York
University of Buffalo
Buffalo, New York, United States, 14222
Beth Israel Medical Center
New York, New York, United States, 10003
NYU Langone Medical Center
New York, New York, United States, 10016
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolina Urology Partners
Gastonia, North Carolina, United States, 28054
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Prime Care of SEO
Dresden, Ohio, United States, 43821
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29605
Southern Urogynecology
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Center for Pelvic Health
Franklin, Tennessee, United States, 37067
United States, Texas
Practice Research Organization
Dallas, Texas, United States, 75230
Houston Metro Urology
Houston, Texas, United States, 77030
Las Colinas ObGyn
Irving, Texas, United States, 75062
United States, Washington
MultiCare Women's Health Care
Covington, Washington, United States, 98042
Sponsors and Collaborators
Boston Scientific Corporation
Integra LifeSciences Corporation
Investigators
Principal Investigator: Peter Rosenblatt, MD Mount Auburn Hospital

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01945580     History of Changes
Other Study ID Numbers: U9920
AUGS PFD Outcome Registry ( Registry Identifier: AUGS PFD Outcome Registry )
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

Keywords provided by Boston Scientific Corporation:
POP
Transvaginal
Native Tissue Repair
Repair Augmented with Mesh
Biologic Graft
Pelvic Organ Prolapse

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical