Evaluation of Treatment by Transcutaneous Electrical Nerve Stimulation (TENS) of the Posterior Tibial Nerve for Lower Urinary Tract Disorders in Parkinson's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 17
- 主要终点
- Patient Global Impression of Improvement Score Measure
研究概览
简要总结
Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was reported at the congress of the "Société Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Perinéologie" (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder. Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated with subjective improvement of LUTD assessed with the Patient Global Impression of Improvement (PGI-I) in 5 of the 6 patients.
In view of the encouraging results of this pilot study, we hypothesize that TENS treatment may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and multisystem atrophy (MSA).
详细描述
The principal objective is to compare the efficacy of transcutaneous electrical nerve stimulation of the posterior tibial nerve with placebo stimulation, applied 20 minutes daily for 3 months, in Lower Urinary Tract Disorders (LUTD) in patients with Parkinson's disease or multisystem atrophy, evaluated using the PGI-I (Patient Global Impression of improvement) tool.
The secondary objectives are to compare the efficacy of TENS with placebo stimulation on change before/after 3 months of treatment on:
- the intensity of urinary symptoms, evaluated using the Patient Global Impression of Severity (PGI-S) scale
- the number of voidings in 24 hours, number of episodes of urinary incontinence in 24 hours and maximum bladder capacity, evaluated by a voiding diary over 3 days
- urinary symptoms, evaluated with the urinary symptom profile (USP) questionnaire
- quality of life, assessed by the Qualiveen-SF® questionnaire
- post-void residual volume measured by bladder ultrasound and effect on the development of infectious complications, by comparing the number of urinary infections over 3 months in each group.
Lastly, the safety of TENS will be compared with that of placebo stimulation by the occurrence of adverse events during the 3 months of treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of Parkinson disease or multisystem atrophy
- •Refractory lower urinary tract disorders or contra-indications or intolerance to the usual oral treatments
- •Patient capable of completing the questionnaires
- •Patient whose written informed consent has been obtained
- •Patient registered with a social security scheme
排除标准
- •Pregnancy and breast-feeding
- •Contra-indications to TENS (local skin problems, metal ankle joint replacement, cardiac pacemaker, peripheral neuropathy, subthalamic deep brain stimulation)
- •Associated neurological disorders (stroke, dementia, multiple sclerosis, spinal cord lesions, peripheral neuropathy) or urological disorders (bladder outlet obstruction, cancer, pelvic organ prolapse, interstitial cystitis)
- •Unilateral neurological disability
- •Legally incompetent patient, patient under legal protection
- •Participation in another study during the present study
研究组 & 干预措施
electrical nerve stimulation (TENS)
Two electrodes are attached around the internal malleolus and connected to the TENS unit, by UROSTIM 2.
The sessions last 20 minutes daily (frequency 10Hz, duration 200µs), at maximum intensity of painless stimulation, every day at the same time, on the right side for 3 months.
干预措施: TENS (Device)
Control group
The device will have been previously set to deliver a stimulation below the effective threshold. In all cases, the device displays 20mA. Stimulation sessions are 20 minutes daily, every day at the same time, on the right side for 3 months.
干预措施: Control (Device)
结局指标
主要结局
Patient Global Impression of Improvement Score Measure
时间窗: 3 months
The score is measured after 3 months treatment
次要结局
- Patient global Impression of severity score measure(december 1, 2014)