Clinical trial NCT01244165: Study of Cytrix Use in Pelvic Floor Prolapse Treatment
Official title: Clinical Investigation of Fetal Bovine Dermis Material (Cytrix) for Use in the Treatment of Pelvic Floor Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Vault Prolapse
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of patients reporting intra-operative complications
timeFrame: at procedure
measure: number of treated patients reporting post-operative adverse events
timeFrame: 6 Months
measure: Patient healing time
timeFrame: 6 Months
measure: Incidence of complication in Cytrix treated patients compared to patients in the historical control group
timeFrame: 6 months
measure: Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
timeFrame: 3 months
measure: Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
timeFrame: 6 months
measure: Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
timeFrame: 12 months
measure: Comparison of phone patient questionnaire results between Cytrix Group and Control Group
timeFrame: 6 months
measure: Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
timeFrame: 2 wks
measure: Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
timeFrame: 6 wks
measure: Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results between Cytrix Group and Control Group
timeFrame: 6 months
Secondary outcomes:
measure: Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Milestone Medical Research
name: Oscar A Aguirre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.