Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
45 participants
INTERVENTIONAL
2002-01-31
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cytrix
Observational Study
Cytrix
Control Group
Patients with similar indications who were treated at the same centers using other products
Other treatments for pelvic organ prolapse
Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)
Interventions
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Cytrix
Other treatments for pelvic organ prolapse
Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)
Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
85 Years
FEMALE
Yes
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Boston Scientific
Principal Investigators
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Oscar A Aguirre, MD
Role: PRINCIPAL_INVESTIGATOR
Milestone Medical Research
References
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Goldstein HB, Maccarone J, Naughton MJ, Aguirre OA, Patel RC. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform(R) Matrix) for pelvic reconstructive surgery. BMC Urol. 2010 Dec 13;10:21. doi: 10.1186/1471-2490-10-21.
Other Identifiers
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WH-2004-01
Identifier Type: -
Identifier Source: org_study_id