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
- Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
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
研究组 & 干预措施
Cytrix
Observational Study
干预措施: Cytrix (Device)
Control Group
Patients with similar indications who were treated at the same centers using other products
干预措施: Other treatments for pelvic organ prolapse (Other)
结局指标
主要结局
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
时间窗: 6 wks
Phone-Patient Questionnaire
Number of patients reporting intra-operative complications
时间窗: at procedure
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.
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
时间窗: 12 months
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
时间窗: 3 months
Phone-Patient Questionnaire
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
时间窗: 6 months
Pelvic Floor Distress Inventory (PFDI-SF20) Patient questionnaire, and Pelvic Organ Prolapse Sexual Questionnaire (PISQ-12) Questionnaire
Patient satisfaction after Pelvic Organ Prolapse surgery using Cytrix
时间窗: 2 wks
Phone-Patient Questionnaire
次要结局
- Physician satisfaction in the treatment of patients with pelvic floor prolapse using Cytrix(6 months)