Study of Cytrix Use in Pelvic Floor Prolapse Treatment

Clinical Investigation of Fetal Bovine Dermis Material (Cytrix) for Use in the Treatment of Pelvic Floor Prolapse

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

Study Overview

• Status: Completed
• Conditions: Vaginal Vault Prolapse
• Intervention / Treatment: Device: Cytrix; Other: Other treatments for pelvic organ prolapse

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cytrix; Observational Study	Device: Cytrix
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients reporting intra-operative complications		at procedure
number of treated patients reporting post-operative adverse events		6 Months
Patient healing time	length of hospital stay and pain medication	6 Months
Incidence of complication in Cytrix treated patients compared to patients in the historical control group	Incidence of complication in Cytrix treated patients compared to patients in the historical control group	6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Phone-Patient Questionnaire	3 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Pelvic Floor Distress Inventory (PFDI-SF20) Patient questionnaire, and Pelvic Organ Prolapse Sexual Questionnaire (PISQ-12) Questionnaire	6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix		12 months
Comparison of phone patient questionnaire results between Cytrix Group and Control Group	Comparison of phone patient questionnaire results in Cytrix treated patients compared to patients in the retrospective historical control group where available.	6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Phone-Patient Questionnaire	2 wks
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix	Phone-Patient Questionnaire	6 wks
Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results between Cytrix Group and Control Group	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix	Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix versus any other product currently being the standard method of care; handling characteristics; conformity to the surgical site; ease of suture; procedure length of time	6 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Oscar A Aguirre, MD, Milestone Medical Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): November 19, 2010
• Last Update Submitted That Met QC Criteria: November 18, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: WH-2004-01