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Study of Cytrix Use in Pelvic Floor Prolapse Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244165
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boston Scientific Corporation
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • number of treated patients reporting post-operative adverse events [ Time Frame: 6 Months ]
  • Patient healing time [ Time Frame: 6 Months ]
    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 ]
    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 ]
    Phone-Patient Questionnaire

  • Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix [ Time Frame: 6 months ]
    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 ]
  • Comparison of phone patient questionnaire results between Cytrix Group and Control Group [ Time Frame: 6 months ]
    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 ]
    Phone-Patient Questionnaire

  • Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix [ Time Frame: 6 wks ]
    Phone-Patient Questionnaire

  • Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results between Cytrix Group and Control Group [ Time Frame: 6 months ]
    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 ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244165


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

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
First Submitted: November 17, 2010
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
Last Verified: November 2010

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