Clinical Investigation of Fetal Bovine Dermis Material (Cytrix) for Use in the Treatment of Pelvic Floor Prolapse
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Number of patients reporting intra-operative complications
研究概览
简要总结
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of patients reporting intra-operative complications
时间窗: at procedure
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
时间窗: 6 wks
Phone-Patient Questionnaire
Comparison of Pelvic Floor Distress Inventory (PFDI-SF20) questionnaire results between Cytrix Group and Control Group
时间窗: 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
时间窗: 6 Months
Patient healing time
时间窗: 6 Months
length of hospital stay and pain medication
Incidence of complication in Cytrix treated patients compared to patients in the historical control group
时间窗: 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
时间窗: 6 months
Comparison of phone patient questionnaire results in Cytrix treated patients compared to patients in the retrospective historical control group where available.
次要结局
- Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix(6 months)