Trial record 18 of 22 for:    native american AND (woman OR women OR female)

Xenform Postmarket Surveillance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Boston Scientific Corporation
Sponsor:
Collaborator:
TEI Biosciences Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01945580
First received: September 15, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

To compare transvaginal repair with a biologic mesh to traditional native tissue repair in women surgically treated for anterior/apical pelvic organ prolapse with or without concurrent cystocele.


Condition Intervention
Anterior and Apical Pelvic Organ Prolapse
Procedure: Prolapse Repair

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Surgical Success [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    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:
  • Incidence of complications [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 454
Study Start Date: February 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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/apical pelvic organ prolapse with or without concurrent cystocele. 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

Ages Eligible for Study:   18 Years and older
Genders 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 or C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL (for a multi-compartment prolapse that includes the apical compartment).
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945580

Contacts
Contact: Lisa LeBlanc 508-683-6636 lisa.leblanc@bsci.com

  Show 29 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
TEI Biosciences Inc.
Investigators
Principal Investigator: Peter Rosenblatt, MD Mount Auburn Hospital
Study Director: Aaron Kirkemo, MD Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01945580     History of Changes
Other Study ID Numbers: U9920, AUGS PFD Outcome Registry
Study First Received: September 15, 2013
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 26, 2014