The Effect of Pelvic Floor Muscle Training and Neuromuscular Electrical Stimulation on Urinary Incontinence and Quality of Life in Women With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)
研究概览
简要总结
The purpose of this study is to determine whether pelvic floor muscle training (PFMT) and intravaginal neuromuscular electrical stimulation (NMES) are effective in reducing urinary incontinence and improving quality of life in women with spinal cord injury (SCI).
详细描述
SCI patients often experience neurogenic bladder dysfunction with neurogenic detrusor overactivity or areflexic bladder. Due to this, 40-50 % of the SCI population suffers from urinary incontinence, which often reduces the patient's quality of life.
In order to manage the neurogenic bladder dysfunction, SCI patients use specialized bladder emptying methods, most frequently clean intermittent catheterization. To reduce the symptoms of neurogenic detrusor overactivity and urinary incontinence in patients with a SCI, medical anticholinergic therapy can be assessed, but the effect is sparse and many adverse effects have been reported. Injection of Botulinum-A toxin in the bladder has shown great potential in minimizing the symptoms of neurogenic detrusor overactivity and urinary incontinence, though it is an expensive and invasive method that needs to be repeated due to its temporary effect.
PFMT and NMES of the pelvic muscles are non-invasive and cheap treatments without side effects and several studies have demonstrated the positive effect of intravaginal NMES and/or PFMT on urinary incontinence in able-bodied women as well as women with neurological disorders like multiple sclerosis.
Despite the fact that NMES of weak or paralyzed striated muscles has been used for decades in patients suffering from SCI, to our knowledge, no study has previously investigated the effect of PFMT and intravaginal NMES in women with SCI.
The aim of this study is to evaluate the effect of PFMT and intravaginal NMES on Urinary Incontinence and Quality of Life in women with SCI. In particular, we will investigate the potential additional effect of intravaginal NMES, when NMES is conducted in combination with PFMT.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Incomplete SCI graded C, D og E on ASIA Impairment Scale, sustained minimum 3 months ago
- •urinary incontinence, corresponding to a total ICIQ-UI-SF score ≥ 8
排除标准
- •Regular treatment with botox bladder injections or < 1 year since last botox injection
- •Lack of urodynamic investigation after the SCI
- •Pregnancy
- •Pacemaker
- •Lack of ability to contract the pelvic floor muscles during objective clinical examination
研究组 & 干预措施
Pelvic floor muscle training (PFMT)
Pelvic floor muscle training daily during 12 weeks.
干预措施: Pelvic floor muscle training (Behavioral)
PFMT and electrical stimulation
Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.
干预措施: Pelvic floor muscle training (Behavioral)
PFMT and electrical stimulation
Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.
干预措施: vaginal electrical stimulator (CefarPeristim Pro) (Drug)
结局指标
主要结局
International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)
时间窗: up to week 24
次要结局
- International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB)(up to week 24)
- Urethral Pressure Reflectometry (UPR) parameters(up to week 24)
- 3 days voiding diary(3 days)
- 24 hour pad test(24 hour)
- International Spinal Cord Injury Quality of Life Basic Data Set(up to week 24)
- Patient Global Index of Improvement scale (PGI-I)(up to week 24)
研究者
Marlene Elmelund
MD
Glostrup University Hospital, Copenhagen