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OpenTrials
Completed

NCT Number: NCT03682926

Electrostimulation PROTOCOL Incontinence

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)

Completed

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Electro-stimulation

Other

Intracavitary electrostimulation with Quark medical vaginal electrode for perineal muscle strengthening protocol.

Other names: electro physical therapy, dualpex 961 quark

Primary outcomes

  1. contractile function of the perineal musculature

    Time frame: 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)

Secondary outcomes

  1. King's Health Questionnaire

    Time frame: 3 months

    It allows qualitative evaluation of the impact of urinary incontinence on the quality of life of women, it is responsible for 20 questions, divided into 8 domains, in addition to these domains, there are two other independent scales: the first evaluates the severity of UI (severity measures) and the second, the presence and intensity of urinary symptoms through the scale of urinary symptoms (VAS) where there is a graduation from 0 to 10, where the higher the score, the higher the severity

Sponsors and collaborators

Lead sponsor

Hospital Universitário Professor Edgard Santos

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 25, 2018
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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