Sacral Neuromodulation for Patients With Multiple Sclerosis With Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction. A Multicenter Double-blind, Placebo-controlled Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Success of SNM for neurogenic lower urinary tract dysfunction
研究概览
简要总结
A multi-center double-blinded placebo-controlled randomized clinical trial.
The patients will be randomized into two groups.
To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD).
After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF.
Period of randomization: four months. Number anticipated to be included: 60 patients
详细描述
Patients with MS often suffer from pelvic-organ dysfunctions, i.e. lower urinary tract (LUT), bowel and sexual dysfunction, aside their cerebral affection. Sacral neuromodulation (SNM) is a reversible minimal invasive procedure affecting the function of the aforementioned pelvic organs. Changes in bladder, bowel and sexual function will be monitored.
Primary outcome:
Success of SNM for lower urinary tract dysfunction as improvement of at least 50% in the key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to the baseline values.
Secondary outcome:
To assess the changes in bladder, bowel and sexual function due to SNM by using subjective patient reported outcome measures, quality of life and global assessment score,
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After a month of optimization where the IPG is turned on at subsensory stimulation the participants will be randomly assigned to either intervention or placebo group with a 1:1 allocation as per a computer generated randomization schedule by a clinician who is not involved in the assessment of the clinical outcome.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory neurogenic lower urinary tract dysfunction (nLUTD) defined by visual analogue scale on treatment satisfaction ranging from 0 to 100 (100 means maximal satisfaction with the current treatment). All patients indicating satisfaction less than 50 are considered non-responders/having refractory overactive bladder (OAB) to current treatment
- •No effect of medical treatment defined by antimuscarinics, beta3-agonist and alpha-blocker.
- •Patients having refractory nLUTD who intend to try SNM for relief of their symptoms
- •Expanded Disability Status Scale (EDSS) < 5 and no progression of neurological disease within 6 months
- •Written informed consent
- •Able to understand the information given about the project
排除标准
- •EDSS > 5, neurological disease with severe progression within the last 6 months and/or unable to manage the electronic devices
- •Age < 18 years
- •Any other urological pathology but nLUTD
- •Bladder Pain Syndrome/Interstitial cystitis
- •Any other intestinal or gynecological pathology but neurological conditional symptoms
- •Current pelvic malignancy or clinically significant pelvic mass
- •Previous pelvis radiotherapy
- •Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial
- •Unable to manage the electronic devices
- •Inability to give an informed consent
研究组 & 干预措施
IPG turned ON
Continous neuromodulation
干预措施: Turning ON the neuromodulator (Device)
IPG turned OFF
No neuromodulation
干预措施: Turning OFF the neuromodulator (Device)
结局指标
主要结局
Success of SNM for neurogenic lower urinary tract dysfunction
时间窗: Six months
Success is defined as improvement of at least 50% in the key bladder diary variables, i.e. number of voids and/or number of leakages, post void residual volumen, compared to the baseline values using BLADDER DIARY for three days before inclusion and at evaluation.
Male bladder function
时间窗: Six months
Male lower urinary tract symptoms (MLUTS) by standard International Consultation on Incontinence Questionnaire (ICIQ)-MLUTS 10/06. Scale ranges from 0 to 44 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
Female bladder function
时间窗: Six months
Female lower urinary tract symptoms (FLUTS) by standard questionnaire ICIQ-FLUTS 12/07. Scale ranges from 0 to 48 points. Higher score indicate greater impact of individual symptoms for the patient. Changes will be compared to basal data.
次要结局
- Bowel function(Eight months)
- Changes in bladder sensation Mangler(Six months)
- Changes in bladder volume(Six months)
- Male sexual function(Six months)
- Female sexual function(Six months)
- Quality of life by standard questionnaire EQ-5D-5L(Six months)
研究者
Hanne Kobberø
Principal investigator, MD
Odense University Hospital