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Study of Cytrix Use in Pelvic Floor Prolapse Treatment

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01244165
First received: November 17, 2010
Last updated: November 18, 2010
Last verified: November 2010
History of Changes
  Purpose

To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.


Condition Intervention Phase
Vaginal Vault Prolapse
 Device: Cytrix
Other: Other treatments for pelvic organ prolapse
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of Fetal Bovine Dermis Material (Cytrix) for Use in the Treatment of Pelvic Floor Prolapse

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Number of patients reporting intra-operative complications [ Time Frame: at procedure ] [ Designated as safety issue: Yes ]
  • number of treated patients reporting post-operative adverse events [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Patient healing time [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    length of hospital stay and pain medication

  • Incidence of complication in Cytrix treated patients compared to patients in the historical control group [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of complication in Cytrix treated patients compared to patients in the historical control group

  • Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Phone-Patient Questionnaire

  • Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pelvic Floor Distress Inventory (PFDI-SF20) Patient questionnaire, and Pelvic Organ Prolapse Sexual Questionnaire (PISQ-12) Questionnaire

  • Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Comparison of phone patient questionnaire results between Cytrix Group and Control Group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison of phone patient questionnaire results in Cytrix treated patients compared to patients in the retrospective historical control group where available.

  • Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix [ Time Frame: 2 wks ] [ Designated as safety issue: No ]
    Phone-Patient Questionnaire

  • Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix [ Time Frame: 6 wks ] [ Designated as safety issue: No ]
    Phone-Patient Questionnaire

  • Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results between Cytrix Group and Control Group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results in Cytrix treated patients compared to patients in the retrospective historical control group where available.


Secondary Outcome Measures:
  • Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix versus any other product currently being the standard method of care;

    1. handling characteristics
    2. conformity to the surgical site
    3. ease of suture
    4. procedure length of time


Enrollment: 45
Study Start Date: January 2002
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cytrix
Observational Study
 Device: Cytrix
Control Group
Patients with similar indications who were treated at the same centers using other products
 Other: Other treatments for pelvic organ prolapse
Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female >30 years of age
  • Willing and able to comply w/ the study procedures and provide written informed consent to participate in the study.
  • Diagnosed with pelvic organ prolapse with or without pelvis floor dysfunction
  • Patient is willing to complete PFDI-SF20 and PISQ-12 questionnaires at 6 and 12 months post-operatively
  • Patient is willing to answer phone questionnaires at 2 weeks, 6 weeks, and 3 months
  • Patients with a history of pelvic surgery (cystocele/anterior repair, hysterectomy, vault suspension, etc) prior to this procedure are allowed to participate in the study except if the patient had a dermal graft implanted.

Exclusion Criteria:

  • Patients who, in the clinical judgment of the investigator, are not suitable for this study
  • Patients who are, in the Investigators opinion, mentally or legally incapacitated preventing informed consent or unable to read or understand written material.
  • Patients who have participated in an investigational study within 30 days of study entry that may impact analysis of this device or have previously participated in the current trial
  • Patient whose pelvic organ prolapse is Stage I
  • Patient with Diabetes Mellitus type I or II
  • Patient with morbid obesity (weight parameters determined by physician)
  • Patient with undiagnosed pelvic mass outside of the uterus (not expected to be functional in nature)
  • Patient with unexplained abnormal menstrual bleeding
  • Patient with any acute or chronic infection (kidney, bladder, lung, etc)
  • Patient with coagulopathy
  • Patient participating in other investigational device or drug study
  • Patients must not be pregnant
  • Patients with life expectancy less than 2 years
  • Patients with known or suspected hypersensitivity to collagen or bovine products
  • Patients with preexisting local or systemic infection
  • Patients with a history of soft tissue pathology where the implant is to be placed
  • Patients with any pathology that would limit the blood supply and compromise healing
  • Patient diagnosed with autoimmune connective tissue disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244165

Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Oscar A Aguirre, MD Milestone Medical Research
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janice Connor / Director, Clinical Affairs, Boston Scientific
ClinicalTrials.gov Identifier: NCT01244165     History of Changes
Other Study ID Numbers: WH-2004-01
Study First Received: November 17, 2010
Last Updated: November 18, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013