A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 54
- 主要终点
- Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months
研究概览
简要总结
The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
详细描述
The primary objective is to evaluate clinical effectiveness of transvaginal repair with mesh (Uphold LITE) against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Uphold LITE-related complications and subject reported outcomes.
The primary endpoint of the study is to achieve superiority of transvaginal repair with mesh (Uphold LITE) over native tissue repair at 36 months as compared to baseline. Success will be based on a composite of objective and subjective measures.
Additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with mesh (Uphold LITE) to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point.
The secondary endpoints of the study include assessments of complications and subject reported outcomes.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female
- •Subject is ≥18 years of age
- •Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 or (for prolapse of the anterior compartment alone) C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments).
- •Subject reports of a bothersome bulge they can see or feel per PFDI-20, question 3 response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
- •Subject or subject's legally authorized representative must be willing to provide written informed consent
- •Subject is willing and able to comply with the follow-up regimen
排除标准
- •Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
- •Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
- •Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
- •Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- •Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis polymyalgia rheumatica)
- •Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
- •Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
- •Subject has a previous prolapse repair with mesh in the target compartment
- •Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
- •Subject is not able to conform to the modified dorsal lithotomy position
- •Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that includes the pelvis
- •Subject has uncontrolled diabetes mellitus (DM)
- •Subject is currently participating in or plans to participate in another device or drug study during this study
- •Subject has a known hypersensitivity to polypropylene mesh
- •Subject is pregnant or intends to become pregnant during the study
结局指标
主要结局
Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months
时间窗: 36 months
A co-primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Uphold LITE vs. NTR for safety by comparing the overall complication rate (device-related and/or procedure-related SAEs) at 36 months
Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
时间窗: 36 Months
Success based on a composite of objective and subjective measures: 1. Objective success was achieved by the subject having an anatomic outcome defined as the leading edge of prolapse at or above the hymen in the operated compartment: * Anterior segment: Leading edge of anterior prolapse was at or above the hymen or POP-Q point Ba ≤ 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. 2. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (\< 2). 3. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery (i.e., 'treated segment' refers to the target compartment).
次要结局
- Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects(6 Month, 12 Months, 18 Months, 24 Months, 36 Months, Overall)
- Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects(6 Month, 12 Months, 18 Months, 24 Months, 36 Months)
- Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months(36 Months)
- Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events(36 Months)
- Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure(36 Months)
- Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects(6 Month, 12 Months, 18 Months, 24 Months, 36 Months)
- Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects(6 Month, 12 Months, 18 Months, 24 Months, 36 Months)
- Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects(6 Month, 12 Months, 18 Months, 24 Months, 36 Months)
- Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects(6 Month, 12 Months, 18 Months, 24 Months, 36 Months)