Xenform Postmarket Surveillance Study

NCT01945580 | Completed Results

• 2 other identifiers: U9920AUGS PFD Outcome Registry
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 25

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.

Conditions

Pelvic Organ Prolapse

Keywords

POP; Transvaginal; Native Tissue Repair; Repair Augmented with Mesh; Biologic Graft; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Success at 36 Months

  The primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Xenform over NTR at 36 months as compared to baseline. Success was based on a composite of objective and subjective measures. 1. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (\< 2). 2. Anatomic success (in the operated compartment): * Anterior segment: Leading edge of anterior prolapse was at or above the hymen or Pelvic Organ Prolapse Quantification System (POP-Q) point Ba ≤ 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. 3. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use

  36 Months

• Number of Participants With One or More Serious Device-related and/or Procedure-Related Adverse Events

  Co-primary endpoint of the study was to achieve non-inferiority of transvaginal mesh repair with Xenform to NTR for safety by comparing rates of serious device-related or serious procedure-related complications between baseline and the 36-month time point.

  36 months

Secondary Outcomes (11)

• Number of Participants With Mesh Erosion

  36 months

• Number of Participants With Mesh Exposure

  36 Months

• Number of Participants With de Novo Dyspareunia

  36 months

• Subject Specific Outcomes Measured With the Pelvic Floor Impact Questionnaire (PFIQ-7)]

  36 months

• Subject Specific Outcomes Measured by the Pelvic Floor Symptoms Per the Pelvic Floor Distress Inventory (PFDI-20)

  36 months

Study Arms (2)

Xenform

ACTIVE COMPARATOR

Prolapse Repair with Xenform Soft Tissue Repair Matrix

Procedure: Prolapse Repair

Control

ACTIVE COMPARATOR

Prolapse Repair with Native Tissue Only

Procedure: Prolapse Repair

Interventions

Prolapse Repair PROCEDURE

Transvaginal anterior/apical pelvic organ prolapse repair

Also known as: Transvaginal, Prolapse, POP Repair, Anterior, Apical

Control; Xenform

Eligibility Criteria

• Age: 18 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (25)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Cherokee Womens Health Specialist

Canton, Georgia, 30114, United States

Location

NorthShore University Health System

Skokie, Illinois, 60076, United States

Location

Acadia Women's Health

Crowley, Louisiana, 70526, United States

Location

Chesapeake Urology Research Associates

Hanover, Maryland, 21061, United States

Location

Chesapeake Urology Research Associates

Owings Mills, Maryland, 21117, United States

Location

Mount Auburn Hospital

Cambridge, Massachusetts, 02138, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

Cooper University Hospital

Voorhees Township, New Jersey, 08043, United States

Location

University of Buffalo

Buffalo, New York, 14222, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Carolina Urology Partners

Gastonia, North Carolina, 28054, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Prime Care of SEO

Dresden, Ohio, 43821, United States

Location

Prisma Health System

Greenville, South Carolina, 29605, United States

Location

Southern Urogynecology

West Columbia, South Carolina, 29169, United States

Location

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

Location

Practice Research Organization

Dallas, Texas, 75230, United States

Location

Houston Metro Urology

Houston, Texas, 77030, United States

Location

Las Colinas ObGyn

Irving, Texas, 75062, United States

Location

MultiCare Women's Health Care

Covington, Washington, 98042, United States

Location

Related Publications (1)

• Lipetskaia L, Gonzalez RR, Wu JM, Northington GM, Henley BR, Lane F, Brucker BM, Jarnagin B, Rosenblatt PL. Thirty-six-month Prospective Study of Transvaginal Bovine Graft vs Native Tissue Repair for the Treatment of Pelvic Organ Prolapse. Urology. 2022 Sep;167:234-240. doi: 10.1016/j.urology.2022.06.003. Epub 2022 Jun 15.

  PMID: 35716871 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Boston Scientific

teresa.takle-flach@bsci.com

952-930-6000

Study Officials

• Peter Rosenblatt, MD

  Mount Auburn Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2013
• First Posted: September 18, 2013
• Study Start: February 10, 2014
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Locations

US (25)