A Prospective, Non-Randomized, Parallel Cohort, Multi-Center Study of Xenform vs. 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
- 374
- 试验地点
- 47
- 主要终点
- Number of Participants With Success at 36 Months
研究概览
简要总结
To compare transvaginal repair with a biologic graft 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 Xenform against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Xenform-related complications and subject reported outcomes.
The primary endpoint of the study is to achieve non-inferiority of transvaginal repair with Xenform 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 Xenform 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 —（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 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 (for prolapse of the anterior compartment alone) or 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 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 is willing to provide written informed consent
- •Subject is willing and able to comply with the follow-up regimen
排除标准
- •Subject is pregnant or intends to become pregnant during the study
- •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), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis, polymyalgia rheumatica)
- •Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- •Subject has uncontrolled diabetes mellitus (DM)
- •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 is not able to conform to the modified dorsal lithotomy position
- •Subject is currently participating in or plans to participate in another device or drug study during this study
- •Subject has a known sensitivity to any Xenform component
- •Subject has had previous prolapse repair with mesh in the target compartment
- •Subject is planning to undergo a concomitant prolapse repair with use of mesh in the non-target compartment
结局指标
主要结局
Number of Participants With Success at 36 Months
时间窗: 36 Months
The primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Xenform over NTR at 36 months as compared to baseline. Success was based on a composite of objective and subjective measures. 1. 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). 2. Anatomic success (in the operated compartment): * Anterior segment: Leading edge of anterior prolapse was at or above the hymen or Pelvic Organ Prolapse Quantification System (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. 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
Number of Participants With One or More Serious Device-related and/or Procedure-Related Adverse Events
时间窗: 36 months
Co-primary endpoint of the study was to achieve non-inferiority of transvaginal mesh repair with Xenform to NTR for safety by comparing rates of serious device-related or serious procedure-related complications between baseline and the 36-month time point.
次要结局
- Subject Specific Outcomes Measured With the Pelvic Floor Impact Questionnaire (PFIQ-7)](36 months)
- Number of Participants With Mesh Erosion(36 months)
- Number of Participants With de Novo Dyspareunia(36 months)
- Subject Specific Outcomes Measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)(36 months)
- Number of Participants With Mesh Exposure(36 Months)
- Subject Specific Outcomes Measured by the Pelvic Floor Symptoms Per the Pelvic Floor Distress Inventory (PFDI-20)(36 months)
- Subject Specific Outcomes: Pain Measured by the TOMUS Pain Scale(36 months)
- Subject Improvement Measured by the Patient Global Impression of Improvement for Prolapse (PGI-I)(36 months)
- Number of Participants With Re-Intervention or Re-Surgery(36 months)
- Surgical Success(36 months)
- Incidence of Complications(36 Months)