Clinical trial NCT01945580: Xenform Postmarket Surveillance Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: POP
Transvaginal
Native Tissue Repair
Repair Augmented with Mesh
Biologic Graft
Pelvic Organ Prolapse
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-09-18
Enrollment: 374
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Success at 36 Months
timeFrame: 36 Months
measure: Number of Participants With One or More Serious Device-related and/or Procedure-Related Adverse Events
timeFrame: 36 months
Secondary outcomes:
measure: Number of Participants With Mesh Erosion
timeFrame: 36 months
measure: Number of Participants With Mesh Exposure
timeFrame: 36 Months
measure: Number of Participants With de Novo Dyspareunia
timeFrame: 36 months
measure: Subject Specific Outcomes Measured With the Pelvic Floor Impact Questionnaire (PFIQ-7)]
timeFrame: 36 months
measure: Subject Specific Outcomes Measured by the Pelvic Floor Symptoms Per the Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: 36 months
measure: Subject Specific Outcomes Measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
timeFrame: 36 months
measure: Subject Specific Outcomes: Pain Measured by the TOMUS Pain Scale
timeFrame: 36 months
measure: Subject Improvement Measured by the Patient Global Impression of Improvement for Prolapse (PGI-I)
timeFrame: 36 months
measure: Number of Participants With Re-Intervention or Re-Surgery
timeFrame: 36 months
measure: Surgical Success
timeFrame: 36 months
measure: Incidence of Complications
timeFrame: 36 Months
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Canton
country: United States
facility: Cherokee Womens Health Specialist
state: Georgia
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: Crowley
country: United States
facility: Acadia Women's Health
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Owings Mills
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Cambridge
country: United States
facility: Mount Auburn Hospital
state: Massachusetts
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Voorhees
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Gastonia
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Dresden
country: United States
facility: Prime Care of SEO
state: Ohio
city: Greenville
country: United States
facility: Prisma Health System
state: South Carolina
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
city: Dallas
country: United States
facility: Practice Research Organization
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Irving
country: United States
facility: Las Colinas ObGyn
state: Texas
city: Covington
country: United States
facility: MultiCare Women's Health Care
state: Washington
Study officials:
affiliation: Mount Auburn Hospital
name: Peter Rosenblatt, MD
role: PRINCIPAL_INVESTIGATOR
References: