Status:
COMPLETED
Study of Cytrix Use in Pelvic Floor Prolapse Treatment
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Vaginal Vault Prolapse
Eligibility:
FEMALE
30-85 years
Phase:
PHASE4
Brief Summary
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01244165
Start Date
January 1 2002
End Date
October 1 2006
Last Update
November 19 2010
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