Study of Cytrix Use in Pelvic Floor Prolapse Treatment

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

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

Conditions
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Vaginal Vault Prolapse

Intervention / Treatment
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* Device: Cytrix
* Other: Other treatments for pelvic organ prolapse


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cytrix<br>Observational Study | Device: Cytrix<br> <br> |
| Other: Control Group<br>Patients with similar indications who were treated at the same centers using other products | Other: Other treatments for pelvic organ prolapse<br>* Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)<br>|

What is the study measuring?
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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 |