Anterior And Multi-Compartment Vaginal Prolapse Repair Augmented With Decellularized Human Dermal Allograft: A Prospactive, Randomized Controlled, Post Market Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Safety through AE and SAE assessments and percentage of incidences
研究概览
简要总结
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
详细描述
The investigator is comparing FDA-approved DermaPure with patient's own native tissue for the repair of pelvic organ prolapse. Please see below for detailed objectives and endpoints for our measuring parameters:
Objectives
Specific Aim #1:
To determine the relative safety and efficacy of anterior and multi-compartment vaginal wall prolapse repair augmented with decellularized human dermal allograft (DermaPure®) versus anterior and multi-compartment repair employing native tissue.
Specific Aim #2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female
- •Subject is at least 18 years of age
- •Subject has prolapse of the anterior compartment beyond the hymen
- •Subject reports bulge symptoms as defined in question 3 of the PFDI-20 with a response of 2 or higher ("somewhat", "moderately" or "quite a bit")
- •Subject is willing and able to provide informed consent
- •Subject is willing and able to comply with the follow-up protocol through 36 months
排除标准
- •Subject is pregnant or intends to become pregnant during the study
- •Subject has untreated severe urogenital atrophy
- •Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
- •Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
- •Subject has had prior pelvic radiation therapy
- •Subject has taken systemic steroids within the last month, or immunosuppressive or immunomodulatory treatment within the last 3 months (list attached)
- •Subject has a history of poor wound healing with or without a diagnosis of connective tissue disease
- •Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- •Subject has uncontrolled diabetes mellitus (DM) as defined by a hemoglobin A1C < or = to 8% (Underwood, Ata)
- •Subject has a known neurologic or medical condition that may effect of currently affects bladder function
- •Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
- •Subject is not able to conform to the modified dorsal lithotomy position
- •Subject is currently participating in or plans to participate in another pelvic organ prolapse related study during this study
- •Subject has had previous prolapse repair with synthetic mesh in the anterior compartment
- •Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue or DermaPure®
- •Subject is unable to be treated in the anterior compartment with DermaPure®
- •Subject is desirous of a concomitant hysteropexy
结局指标
主要结局
Safety through AE and SAE assessments and percentage of incidences
时间窗: 3 years
The relative proportion of allograft, native tissue, and procedure-related SAE's is assessed at 12 months, 24 months, and 36 months. The relative proportion of allograft, native tissue, and procedure-related AE's of interest is assessed at 12 months, 24 months, and 36 months which include: * Vaginal shortening * Vaginal scarring or banding * De novo vaginal bleeding * Atypical vaginal discharge * Fistula formation * De novo dyspareunia * Pelvic pain * Peri-operative infection * Vaginal infection * UTI * Neuromuscular disorder * SUI (worsening or de novo) * UUI (worsening or de novo) * Difficulty emptying bladder (worsening or de novo) * Graft exposure (into vagina) * Graft erosion (into viscus)
Quality of Life through the administration of questionnaires, analyzed at the end of the study as % of patients that are satisfied or above satisfied
时间窗: 3 years
The proportion of patients in each group at 36 months with bulge symptoms attributable to the target compartment as determined by PFDI-20 question number 3 ("Do you usually have a bulge or something falling out that you can see or feel in the vaginal area") answering "yes" and \>= 2 (responses of "somewhat", "moderately", or "quite a bit"). (Barber) Change in quality of life in each group from baseline to 36 months as measured by the PFDI-20 and the PFIQ-7. (Barber)
次要结局
未报告次要终点