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Xenform Postmarket Surveillance Study (Xenform)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Boston Scientific Corporation
Integra LifeSciences Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: September 15, 2013
Last updated: June 7, 2016
Last verified: June 2016
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 Intervention
Pelvic Organ Prolapse
Procedure: Prolapse Repair

Study Type: Observational [Patient Registry]
Study Design: 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

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: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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
  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 identifier: NCT01945580

Contact: Laura Olson +1 952-930-6428

  Show 28 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Integra LifeSciences Corporation
Principal Investigator: Peter Rosenblatt, MD Mount Auburn Hospital
Study Director: Aaron Kirkemo, MD Boston Scientific Corporation
  More Information

Responsible Party: Boston Scientific Corporation Identifier: NCT01945580     History of Changes
Other Study ID Numbers: U9920  AUGS PFD Outcome Registry 
Study First Received: September 15, 2013
Last Updated: June 7, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical processed this record on December 07, 2016