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临床试验/NCT05954234
NCT05954234已完成不适用

Combining Pelvic Floor Rehabilitation With Postural Re-education in Women With Stress Urinary Incontinence and Chronic Low Back Pain: a Preliminary Study.

I.R.C.C.S. Fondazione Santa Lucia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF)

研究概览

简要总结

Stress Urinary incontinence (SUI) is a common health condition in female population. Although its prevalence increases with the age, women of all ages could be affected. Several epidemiological studies have shown an association of SUI with Low Back Pain (LBP) demonstrating, moreover, that the presence of one condition may predispose the patient to the onset of the other. Concerning the LBP, the clinical practice guidelines provided recommendations for physical rehabilitative treatment. Different techniques and physical exercises have been developed and it is difficult at the date to affirm the superiority of one approach as compared to another. Moreover, the crucial role plays by the pelvic floor muscles (PFM) both as an integral part of trunk and lumbo-pelvic stability and in maintenance of urinary continence, lead the pelvic floor muscles disfunction to be associated both with SUI and LBP, making the PFM rehabilitation a useful approach in both the conditions. In this rehabilitative context the present study aims to verify the effectiveness of a global physical approach based on postural re-education combined to the pelvic floor rehabilitation in women with diagnosis of stress urinary incontinence associated with non-specific chronic low back pain.

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)

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

入选标准

  • woman aged from 18 to 75 years;
  • diagnosis of Stress Urinary Incontinence associated with non-specific chronic Low Back Pain

排除标准

  • severe pelvic organs prolapse (>second stage following the International Continence Society (ICS) classification);
  • pregnancy;
  • perineal denervation;
  • inverted perineal command;
  • presence of pelvic pain;
  • fecal incontinence;
  • vaginal infections;
  • associated pathologies involving the Central Nervous System (CNS);
  • psychotic disorders

结局指标

主要结局

International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF)

时间窗: Baseline, after after 5 weeks of treatment , and 1 month after the end of training

Change of International Consultation on Incontinence Questionnaire-Urinary Short Form (ICIQ-UI SF) from baseline, at 10 sessions of treatment, and at 30 days after the end of the training. The ICIQ-UI SF evaluate the frequency, severity and impact on quality of life (QoL) of urinary incontinence. It is ranging from 0 to 21 where 0 is the minimum and 21 the maximum. An higer score indicates greater impairment from incontinence.

次要结局

  • Pain Visual Analogue Scale (VAS)(Baseline, after 5 weeks of treatment , and 1 month after the end of training)
  • Modified Oxford Scale (MOS)(Baseline, after 5 weeks of treatment , and 1 month after the end of training)

研究者

发起方
I.R.C.C.S. Fondazione Santa Lucia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Tramontano

Head of Rehabilitation Services

I.R.C.C.S. Fondazione Santa Lucia

研究点 (2)

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