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临床试验/NCT03682926
NCT03682926已完成不适用

EFFECT OF A PROTOCOL Electrostimulation for Urinary Incontinence and Its Influence on WOMEN 'S QUALITY OF LIFE

Hospital Universitário Professor Edgard Santos0 个研究点目标入组 20 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
contractile function of the perineal musculature

研究概览

简要总结

To verify the effect of an adapted electrostimulation (EE) protocol for stress and mixed urinary incontinence (SUI / M) and its impact on quality of life (QoL)

详细描述

Controlled and randomized clinical trial performed at the Physiotherapy Outpatient Clinic at the Magalhães Neto Pavilion of ComHUPES / UFBA. Women aged between 30 and 65 years and diagnosis of SUI / IUM. The patients were allocated to two groups (GA) submitted to selective electrostimulation for tonic fiber, phasic fibers IIa / IIb and different times of electrical stimulation; (GB) used 50hz for all fibers by 20mm, both answered the questionnaire King's Health Questionnaire (KHQ).

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, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •women between the ages of 30 and 65
  • •With diagnosis of stress urinary incontinence and / or mixed
  • •Perineal muscle weakness
  • •Accepted to sign the TCLE

排除标准

  • •Women with neurological changes
  • •Pregnant women
  • •Pacemaker
  • •Genitourinary tract infection
  • •Refuse to sign the TCLE

研究组 & 干预措施

electrostimulation individualized

Experimental

Selective electrostimulation for tonic fiber, phasic fiber FIa and FIIb and different stimulus times. Muscle fibers (Tonic) with a frequency of 20Hz, pulse width (t) of 700μs to 1ms, time of rise and fall of the wave of 1.0 seconds, duration of contraction and repetition was based on the perineal evaluation But the resting time was twice as long as sustained. For the IIa (phasic) fibers the frequency was 50 Hz with a pulse width of 400μs to 500μs, for 3 seconds of sustentation and 6 seconds of relaxation, time of rise of 0,5 seconds and 0,5 seconds of descent. E for type IIb (phasic) fibers, 80 Hz frequency, pulse width 250μs to 400μs, 1 second contraction for 3 seconds rest and 0.2 seconds rise and fall time.

干预措施: Electro-stimulation (Other)

electrostimulation with fixed protocol

Active Comparator

Intervention -Electro-stimulate all fibers with a single electrical parameter. Pulse width 700μs, rise and fall time of 2 seconds each, sustain time of 4 seconds and rest 8 seconds for 20 minutes, the intensity will be modulated, as in the previous group by patient tolerance in milliamperes.

干预措施: Electro-stimulation (Other)

结局指标

主要结局

contractile function of the perineal musculature

时间窗: 3 months

Perineal muscle function evaluated subjectively by vaginal touch using the PERFECT system to measure strength (graded from 0 to 5), strength (holding capacity of contraction recorded in seconds) and number of contractions of tonic and phasic fibers (ability to repeat muscle contractions perineal). Objectively, the vaginal cones were used to determine which load the patient was able to support (kit with 5 cones with weights ranging from 20 to 70g)

次要结局

  • King's Health Questionnaire(3 months)

研究者

发起方
Hospital Universitário Professor Edgard Santos
申办方类型
Other
责任方
Principal Investigator
主要研究者

ROSANA CRISTINA PEREIRA DE ANDRADE

Dra

Hospital Universitário Professor Edgard Santos

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