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临床试验/NCT03797365
NCT03797365Unknown不适用

Randomized Trial to Evaluate the Impact of Cognitive Therapy Added to Normal Perineal Rehabilitation on Pelvic Floor Muscle Contraction for Urinary Incontinent Women.

Pierre and Marie Curie University0 个研究点目标入组 40 人开始时间: 2019年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
RT3 - EMG Latency between intercostal muscles contraction and perineal muscles contraction

研究概览

简要总结

This trial is a pathophysiological study evaluating the impact of a cognitive therapy on the perineal neuromuscular mechanisms in women patients with urinary incontinence.

Some research works have been realized on the impact of a cognitive load test (CLT) on the neuromuscular continence urinary mechanisms. It had been demonstrated that a CLT induced an increase in the latency of voluntary perineal contraction. It had also been demonstrated that a CLT had an influence on the involuntary perineal contraction pre-activation. Most recently, the impact of a cognitive therapy on the perineal neuromuscular mechanisms on healthy participants had been evaluated. It demonstrated that a cognitive therapy inhibited the impact of the CLT on the perineal neuromuscular mechanisms.

The present project is about the evaluation of the interest of a cognitive therapy on the neuromuscular mechanisms in case of attentional test in a urinary incontinent women population. It could conduce to new therapeutic leads for the management of urinary incontinence.

详细描述

Objectives and results expected

Cognition seems to have an effect on the physiological mechanisms of urinary continence. Urinary continence is, among others, the effect of a good coordination between detrusor's contraction and pelvic floor muscles' contraction. A cognitive disturbance involves coordination's disturbance. It has already been demonstrated that a double task rehabilitation (between cognition and perineal muscles) could annihilate the effects induced by a cognitive disturbance on the physiological neuromuscular mechanisms of the urinary incontinence. The objective of this study is to evaluate the benefit of a double task cognitive rehabilitation for the patients with urinary incontinence (UI).

Current knowledge situation

Pelvic floor muscles have a major incidence for the physiological urinary continence. Even if the external anal sphincter (EAS)'s muscles are not directly involved in urinary incontinence, many studies have shown they had a synergistic contraction with levator ani muscles during the voluntary and involuntary perineal contraction . Because they are easily reachable for an electromyographic (EMG) recording, many authors have registered these muscles in order to investigate the physiologic urinary continence. Amarenco et al. had shown that pelvic floor muscles' intensity of contraction in response to a cough fit was proportional to the cough intensity in an healthy volunteers population. This correlation was beyond bladder's filling. For the patients with UI, Deffieux et al. shown a loss of correlation between cough intensity and perineal contraction. Deffieux et al. also analyzed the temporal sequence of muscle activation for the EAS during a cough fit. A perineal pre contraction in an healthy volunteers population was observed. EAS's muscles EMG activation began 210 ms (median) before external intercostal (EIC) muscles. This EAS's muscles anticipation of contraction was not found in the group of patients with UI. The observation that fewer patients were activating their AES's muscles, more the modulation of EAS's muscles contraction was distorted when coughing was made. Thubert et al. observed that the perineal contraction's latency was multiplied by 4 in case of cognitive load test (CLT) in an healthy volunteers population. CLT leads to an EAS's muscles pre activation in case of coughing effort, was also observed. A lowing of 29% of AES's muscles pre activation has been demonstrated. These results suggest that cognition is involved in urinary continence's physiological mechanisms. So it seamed to be interesting to study the impact of a double task rehabilitation (cognitive and muscular) on the urinary continence's neuromuscular mechanisms in case of diversion of attention. It was a randomized trial including two groups of healthy volunteers: one group had double task rehabilitation during 15 days, the other had no rehabilitation. After 15 days rehabilitation, in the rehabilitation's group, the attention deficit's correction restored the resistive abilities of UI in case of attention hijacking.

According to the last AFU's (Association Française d'Urologie - Urology French Association) and CNGOF's (Collège national des gynécologues et obstétriciens français - French Gynecologists and Obstetricians National College) recommendations, the first intention treatment of urinary incontinence is pelvi-perineal rehabilitation. Pelvi-perineal rehabilitation conducted by a therapist is multimodal with different facets: a cognitive part (education, pelvic floor realization), a behavioral part of bladder training (modification of micturition habits), a muscle building part (voluntary contractions against resistance with and without biofeedback and electrosimulation), and also a postural work part (balance and pelvis position). Perineal rehabilitation technics' heterogeneity and the lack of description of these technics let the professionals adapt their rehabilitation's protocols. The objective of this study is to compare the results of two rehabilitation's technics in urinary incontinent patients.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Major women with stress urinary incontinence or mixed urinary incontinence or urge urinary incontinence, in need to benefit from perineal rehabilitation or cognitive-behavioral rehabilitation
  • Women able to read, understand, accept and sign the consent.

排除标准

  • Pregnant women,
  • Refusal to participate
  • Dementia and cognitive troubles (MMS<30).

研究组 & 干预措施

Classical rehabilitation

Active Comparator

Twenty women will benefit from two-phases perineal rehabilitation: first phase pelvic floor muscles (PFM)'s analytic rehabilitation, then a functional rehabilitation.

干预措施: Classical rehabilitation (Other)

Classical and cognitive associated rehabilitation

Experimental

Twenty women will receive, added to the classic perineal rehabilitation, the cognitive rehabilitation and will have to execute twice a day the rehabilitation protocol.

干预措施: Cognitive associated rehabilitation (Behavioral)

结局指标

主要结局

RT3 - EMG Latency between intercostal muscles contraction and perineal muscles contraction

时间窗: Final evaluation at the eighth week follow up

EMG Latency between intercostal muscles contraction and perineal muscles contraction

RT3 - EMG Latency between intercostal muscles contraction and perineal muscles

时间窗: Intermediary evaluation at the fourth week follow up

EMG Latency between intercostal muscles contraction and perineal muscles contraction

次要结局

  • RT1 - EMG Latency between stimulus and perineal muscles contraction(Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up)
  • Urinary Handicap Measurement (Mesure du Handicap Urinaire - MHU)(Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up)
  • International Consultation on Incontinence Questionnaire (ICIQ-SF)(Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up)
  • Questionnaire for assessment of quality of life related to women urinary incontinence (Contilife)(Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up)

研究者

发起方
Pierre and Marie Curie University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thubert Thibault

Principal Investigator, Medical Doctor of Gynecology

Pierre and Marie Curie University

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