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
  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:


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 April 17, 2014