NEUROMOD UCon: Pilot Study of Dorsal Genital Nerve Stimulation for Management of Bladder Overactivity Following Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change from baseline (week 1) in Maximum Cystometric capacity at post intervention (week 9) and follow up (week 13).
研究概览
简要总结
Following spinal cord injury signals between the brain and the bladder are disrupted. As a result the bladder often becomes overactive which can lead to the need for frequent trips to the toilet, regular incontinence episodes and a decreased quality-of-life. Neuromodulation is a therapy that aims to target the nerves that become overactive controlling the bladder, stopping the bladder overactivity on demand using an external (non-invasive) nerve stimulation box and sticker electrodes placed on the penis or clitoris.
This study is a pilot study that aims to investigate neuromodulation for improving symptoms of bladder overactivity when used by 10 people over eight weeks at home. We will assess whether using the device improves bladder capacity, incontinence, frequency of needing the toilet and whether there are any longer lasting changes after 8 weeks. Finally, the study will aim to find out the acceptability of using this type of therapy for participants and the acceptability of the device we are using.
Participants in this trial will participate over 13 weeks and need to visit our centre in Stanmore to have urodynamics tests in the 1st, 9th and 13th week. At home they will use a small stimulation device on a daily basis for 8 weeks to control overactivity in the bladder. Whilst at home they will record relevant outcomes in several three-day diaries and questionnaires. They will record baseline data before starting stimulation and for 4 weeks after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 (suprasacral, AIS A-D);
- •>18 years old, no upper age limit;
- •SCI sustained >6 months ago;
- •Capable of using the device at home either independently or with existing support.
- •Male or female
- •Willing and able to provide informed consent
排除标准
- •recipient of intra-detrusor botulinum toxin injections within the last 6 months;
- •previous surgical intervention on bladder sphincters;
- •pregnancy;
- •cardiac pacemaker;
- •active sepsis;
- •history of significant autonomic dysreflexia;
- •poorly controlled epilepsy;
- •patients with a cancerous tumour in the area of electrical stimulation
结局指标
主要结局
Change from baseline (week 1) in Maximum Cystometric capacity at post intervention (week 9) and follow up (week 13).
时间窗: Week 1, 9 and 13
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
- 3 day bladder diary (3DBD)(Week 1, 2, 5, 9, 10 and 13)
- VAS treatment satisfaction(Week 10)
- Semi structured interview(Week 10)
- Maximum detrusor pressure(Week 1, 9 and 13)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire(Week 1, 5, 10 and 13)
- The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Questionnaire(Week 10)
- Incontinence Quality of Life (I-QoL) Questionnaire(Week 1, 5, 10 and 13)