A Phase II Study of Sacral Nerve Stimulation for Low Anterior Resection Syndrome or Fecal Incontinence in Patients Following a Low Anterior Resection or Proctectomy With Coloanal Anastomosis or in Patients After Pelvic Chemoradiation (RESTORE)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Sacral Nerve Stimulation (SNS) Success
研究概览
简要总结
This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.
详细描述
PRIMARY OBJECTIVES:
I. To investigate the efficacy of sacral nerve stimulator placement in patients with fecal incontinence (FI) or low anterior resection syndrome (LARS) who have previously undergone chemoradiation treatment (XRT) and/or a restorative partial or complete proctectomy with colorectal or coloanal anastomosis for cancer treatment as per standard of care (restorative surgery cohort).
II. To evaluate the feasibility of sacral nerve stimulator placement in patients with fecal incontinence (FI) or other defecatory dysfunction who have received pelvic radiation treatment without undergoing rectal or other pelvic surgery as per standard of cancer care (radiation only cohort).
SECONDARY OBJECTIVES:
I. To evaluate the effectiveness of sacral nerve stimulation (SNS) as measured by validated questionnaires in patients with FI or LARS within both patient cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1: Patients with pathologically proven diagnosis of primary rectal cancer
- •Cohort 1: Patients who have previously undergone surgical resection and anastomosis (restorative) with curative intent treatment with or without chemoradiation
- •Cohort 1: Patients treated with restorative surgical resection without radiation
- •Cohort 1: Patients with any T-stage or N-stage rectal cancer that underwent treatment with radiation and restorative surgery
- •Cohort 1: Patients with self-reported FI or LARS
- •Cohort 1: Patients must be at least 18 years old and be able to speak and understand English
- •Cohort 1: Patients must be willing to and able to sign an approved informed consent document
- •Cohort 1: Patients must be >= 24 months post-resection of rectal cancer
- •Cohort 1: Patients must have failed prior conservative measures such as Metamucil and motility medications and already been assessed and treated in a pelvic floor rehabilitation program (biofeedback) designed to treat FI and LARS, and continue to experience significant defecatory dysfunction, allowable per principal investigator (PI) discretion
- •Cohort 1: Patients must be willing and able to complete Patient Reported Outcomes Questionnaires for before device placement, during the testing phase following lead placement, and after implantation of the battery
- •Cohort 1: Patients must be willing and able to undergo elective ARM testing to objectively measure pelvic floor function
- •Cohort 1: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM
- •Cohort 2: Patients with pathologically proven malignancy of the pelvis, other than rectal cancer (e.g. prostate, bladder, anus, vagina, vulva, cervix, uterus, or ovary)
- •Cohort 2: Patients treated with standard of care radiation therapies without surgical resection
- •Cohort 2: Patients with self-reported FI or other defecatory dysfunction
- •Cohort 2: Patients must be at least 18 years old and be able to speak and understand English
- •Cohort 2: Patients must be willing to and able to sign an approved informed consent document
- •Cohort 2: Patients must be >= 18 months post-pelvic chemoradiation
- •Cohort 2: Patients must have already been assessed and treated in a pelvic floor rehabilitation program design to treat FI or other defecatory dysfunction and continue to experience significant defecatory dysfunction
- •Cohort 2: Patients must be willing and able to complete Patient Reported Outcomes (PROs) and bowel and bladder diaries (Medtronic) at multiple times during the study
- •Cohort 2: Patients must be willing and able to undergo elective ARM testing to measure pelvic floor function
- •Cohort 2: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM
排除标准
- •Cohort 1: Patients with co-morbid illnesses or concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Cohort 1: Any diverting bowel ostomy at the time of consent to this study
- •Cohort 1: Patients with an absolute neutrophil count (ANC) < 1.7 within 30 days of consent
- •Cohort 1: Patients with an international normalized rate (INR) > 1.3 within 30 days of consent
- •Cohort 1: Patients with a platelet count < 50 K within 30 days of consent
- •Cohort 1: Patients currently being treated with chemotherapy or within preceding 30 days at the time consent
- •Cohort 1: Patients previously treated with a SNS for urinary or FI
- •Cohort 1: Patients who were documented to have an anastomotic leak following their restorative surgical resection
- •Cohort 1: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status > 2 at the time of consent
- •Cohort 1: Patients with an active infection requiring systemic therapy at the time of consent
- •Cohort 1: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure
- •Cohort 2: Co-morbid illnesses or other concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Cohort 2: Patients with an ANC < 1.7 within 30 days of consent
- •Cohort 2: Patients with an INR > 1.3 within 30 days of consent
- •Cohort 2: Patients with a platelet count < 50 K, within 30 days of consent
- •Cohort 2: Patients currently being treated with chemotherapy or within the preceding 30 days at the time of consent
- •Cohort 2: Patients previously treated with a sacral nerve stimulator for urinary or fecal incontinence
- •Cohort 2: Patients with an ECOG performance status > 2 at the time of consent
- •Cohort 2: Patients with an active infection requiring systemic therapy at the time of consent
- •Cohort 2: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure
- •Cohort 2: Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
结局指标
主要结局
Sacral Nerve Stimulation (SNS) Success
时间窗: Up to visit 3
SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placement at visit 1 to after lead placement at visit 2. The proportion of patients who experience SNS success will be reported with a 90% credible interval using a beta (1,1)
次要结局
- Fecal Incontinence Severity Index Questionnaire Summary(Up to 3 years)
- Low Anterior Resection Syndrome Score BFQ(Up to 3 years)
- Cleveland Clinic Incontinence Score(Up to 3 years)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29(Up to 3 years)
- Fecal Incontinence Quality of Life Questionnaire Summary(Up to 3 years)
- Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)(Up to 3 years)
- Impact of SNS on Urinary Incontinence(Up to 30 days (visit 2))
- Impact of SNS on Bowel Dysfunction(Up to 30 days (visit 2))
- Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)(Up to 3 years)
- International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms(Up to 3 years)