Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Maximum Cystometric Capacity (bladder capacity) from baseline (week 1) to post intervention (week 16) and follow up (week 28, week 40)
研究概览
简要总结
The investigators will recruit up to 20 volunteers with chronic, supra-sacral SCI. Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator (eSCS) implanted with either percutaneous or paddle electrodes. Preoperative and intraoperative testing will determine exact location of electrodes.
Mapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function, and anorectal physiology investigations of bowel function. The acute effects of eSCS to suppress bladder overactivity, facilitate voiding, prevent unwanted reflex sphincter activity, and pelvic floor function will guide development of eSCS programmes for use at home.
In 'Phase II', participants will use eSCS at home for 12-weeks. Participants will also be taught how to perform bladder and pelvic floor muscle training (PFMT) in combination with eSCS.
Outcome measures assessing bladder, bowel, sexual function, quality of life, motor function and spasticity will be captured prior to and following the 12-week intervention, and at 3 and 6 month follow up.
详细描述
Screening:
Following confirmation that participants meet the eligibility criteria, they will undergo extensive screening, to confirm their suitability for eSCS implantation. They will meet with multidisciplinary team members, to ensure they are fully educated about the potential risks, and to manage their expectations of outcomes. They will undergo a urodynamics assessment, following standard protocol. If they have neurogenic detrusor overactivity (NDO), and are responsive to dorsal genital nerve stimulation to supress NDO they will progress to have an MRI.
Phase I:
Baseline measurements will be completed as outlined in 'outcome measures'. Participants will undergo implantation of a Senza implantable pulse generator (Nevro Corp., CA, USA), which is MRI-conditional and multi-programmable, with Surpass Surgical or Percutaneous leads (Nevro Corp., CA, USA). The device will be implanted under the skin either at the abdomen, superior to iliac crest, or buttocks.
Participants will attend three mapping sessions to determine effective stimulation sites and parameters for the lower limbs, bladder, bowel and pelvic floor muscles. An optional cardiovascular mapping session will also be offered. The mapping sessions will generate several eSCS programmes for participants to use at home, which target specific effects: supression of NDO, facilitation of voiding, bowel management, and pelvic floor muscle activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Spinal Cord Injury (supra-sacral)
- •>18 years;
- •SCI sustained >12 months ago;
- •Neurogenic detrusor overactivity (NDO) confirmed on urodynamics;
- •Responsive to dorsal genital nerve stimulation
- •Willing and able to provide informed consent
- •Stable medical, physical and psychological condition as considered by the investigators
- •Able to understand and interact with the study team in English
- •Sufficient upper limb function to operate the device
- •Suitably optimised bladder and bowel routine
排除标准
- •Transected cord or SCI related to a neurodegenerative disease
- •Any device or metal work in situ that would exclude the patient from having eSCS implanted
- •Intra-detrusor botulinum toxin injections within the last 6 months
- •Previous surgical intervention on bladder sphincters
- •Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor.
- •Recurrent urinary tract infection refractory to antibiotics
- •Women who are pregnant or intending to become pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, or lack of safe contraception for women of childbearing capacity.
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Enrolment of the investigator, his/her family members, employees, and other dependent persons.
结局指标
主要结局
Change in Maximum Cystometric Capacity (bladder capacity) from baseline (week 1) to post intervention (week 16) and follow up (week 28, week 40)
时间窗: Week 1, 16, 28 and 40
During standard cystometry (retrograde filling of the bladder), maximum cystometric capacity will be defined as the volume emptied from the bladder after each fill.
次要结局
- Maximum Detrusor Pressure(Week 1, 16, 28 and 40)
- Rectal and Anal Pressure during Push Manoeuvre(Week 3, 16, 28 and 40)
- 3 day bladder diary(Week 3, 12, 16, 28 and 40)
- Up to 14 day bowel diary(Week 3, 12, 16, 28 and 40)
- Questionnaire - Neurogenic Bladder Symptom Score (NBSS)(Week 2, 16, 28 and 40)
- Questionnaire - Urinary Symptom Profile questionnaire(Week 2, 16, 28 and 40)
- Questionnaire - Neurogenic Bowel Dysfunction Score (NBDS)(Week 2, 16, 28 and 40)
- Questionnaire - EQ-5D-5L Quality of Life questionnaire(Week 2, 16, 28 and 40)
- Questionnaire - ISCOS Lower Urinary Tract Dysfunction Dataset (LUTDD)(Week 2, 16, 28 and 40)
- Questionnaire - The International Index of Erectile Function (IIEF) or The Female Sexual Function Index (FSFI)(Week 2, 16, 28 and 40)
- Questionnaire - Penn Spasm Frequency Scale(Week 2, 16, 28 and 40)
- The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)(Week 2, 16, 28 and 40)
- Colonic Transit Assessment(Week 2, 12 and 40)
- Microbiome Testing(Week 2, 16 and 40)