Promoting Restoration of Function of Co-ordinated Bladder Storage and Voiding Following Spinal Cord Injury by Combination of Transcutaneous Spinal Cord Stimulation and Bladder & Pelvic Floor Muscle Training Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up
研究概览
简要总结
Spinal Cord Injury (SCI) disrupts signals between the brain and the rest of the body, this includes signals needed to control the bladder and bowels. Spinal cord stimulation (SCS) (electrical stimulation through electrodes placed on the skin over the spine) has shown potential to improve bladder function. Additionally pelvic floor muscle training (PFMT), has been shown to help control bladder overactivity and reduce incontinence in people with a SCI.
This study will investigate PFMT with SCS, and its effects on restoring bladder function, and continence. We aim to recruit 25 participants. Those eligible will be patients from the London Spinal Cord Injury Centre with a supra-sacral SCI (>6 months post-injury), aged 16 years old and above.
详细描述
The first five participants who volunteer will be invited to complete 'SCS optimisation'. Testing different SCS electrode positions and stimulation parameters with pelvic floor exercises and during urodynamics (measurement of pressure changes during filling and emptying of the bladder).
For the main study, all participants will complete baseline assessments (week 1) which include: bladder, bowel, sexual function, and quality of life questionnaires, a pelvic floor assessment, and urodynamics. Assessments will be repeated at week 8, and week 14.
After baseline assessments, participants will be randomly allocated to one of two groups. The intervention group will receive 8-weeks of at home PFMT, this will include 3 face-to-face visits, daily text reminders, and a weekly phone call. The control group will continue with usual care for 8-weeks.
At the end of the 8-weeks, all participants will be re-assessed, and will then complete a single session of SCS with urodynamics. Participants will return for their final assessment 6-weeks later (week 14). Participants allocated to the control group will be offered PFMT at the end of the study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Supra-sacral spinal cord injury over 6 months ago
- •Previous urodynamics and management by the Neuro-urology Consultants
- •Proven NDO from latest urodynamics
排除标准
- •Participants under 16 years of age
- •Non-stable SCI or metastatic cord disease
- •Intra-detrusor botulinum toxin injections in previous 6 months
- •Bladder infection on day of investigation
- •Pregnant or trying for a baby (females)
- •Cardiac pacemaker, bladder stimulator or baclofen pump in situ
- •Metal work at thoraco-lumbar level of stimulation
- •Poorly controlled Autonomic Dysreflexia
- •Currently involved in a clinical trial
- •Previous surgical intervention on bladder/sphincters
- •Active sepsis
- •Poorly controlled epilepsy. Acceptable where epilepsy is controlled by drugs or there have been no fits experienced for a reasonable period
- •Patients with a cancerous tumour in the area of the electrical stimulation
- •Patients without the capacity to consent
结局指标
主要结局
Change in maximum detrusor pressure during voiding (MDPvoid) from baseline to follow up
时间窗: Week 1, 8 and 14
Voiding detrusor pressure measured from Cystometrogram/Urodynamic procedures (cmH20)
Change in maximum cystometric capacity (MCC) from baseline to follow up
时间窗: Week 1, 8 and 14
Bladder capacity from Cystometrogram/Urodynamic procedures (ml)
Change in bladder voiding efficiency from baseline to follow up
时间窗: Week 1, 8 and 14
Bladder voiding efficiency measured from Cystometrogram/Urodynamic procedures, \[\[volume voided/volume voided+post void residual)\*100\] (%)
次要结局
- Pelvic Floor Oxford Grading Score(Week 1, 8 and 14)
- Arizona Sexual Experiences Scale (ASEX)(Week 1, 8 and 14)
- Quality of Life Questionnaire EQ-5D-5L(Week 1, 8 and 14)
- The Qualiveen Questionnaire(Week 1, 8 and 14)
- The Neurogenic Bladder Symptom Score (NBSS)(Week 1, 8 and 14)
- Neurogenic Bowel Dysfunction Score (NBDS)(Week 1, 8 and 14)
- Electromyography (EMG) of resting tone and maximum voluntary pelvic floor contraction(Week 1, 8 and 14)
研究者
RNOH RIC
Head of Research and Innovation
Royal National Orthopaedic Hospital NHS Trust