Vaginal Vault Prolapse
Conditions
Brief summary
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
Interventions
DEVICECytrix
OTHEROther treatments for pelvic organ prolapse
Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 patients reporting intra-operative complications | at procedure | — |
| 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 |
| Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix | 3 months | Phone-Patient Questionnaire |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed