To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)
Number of patients reporting intra-operative complications
Time frame: at procedure
number of treated patients reporting post-operative adverse events
Time frame: 6 Months
Patient healing time
length of hospital stay and pain medication
Time frame: 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
Time frame: 6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Phone-Patient Questionnaire
Time frame: 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
Time frame: 6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Time frame: 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.
Time frame: 6 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
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Phone-Patient Questionnaire
Time frame: 2 wks
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
Phone-Patient Questionnaire
Time frame: 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.
Time frame: 6 months
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; 1. handling characteristics 2. conformity to the surgical site 3. ease of suture 4. procedure length of time
Time frame: 6 months