Study of Cytrix Use in Pelvic Floor Prolapse Treatment

Phase 4

Completed

• Conditions: Vaginal Vault Prolapse
• Interventions: Device: Cytrix; Other: Other treatments for pelvic organ prolapse

• Registration Number: NCT01244165
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2010-11
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-18
• Last Update Submitted: 2010-11-18
• Study First Posted: 2010-11-19
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytrix	Cytrix	Observational Study
Control Group	Other treatments for pelvic organ prolapse	Patients with similar indications who were treated at the same centers using other products

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix	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