Electrostimulation PROTOCOL Incontinence

Female Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682926
• Other study ID #: ROAND2015
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2018
• Source: Hospital Universitário Professor Edgard Santos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Stress Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Electro-stimulation
Intracavitary electrostimulation with Quark medical vaginal electrode for perineal muscle strengthening protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	contractile function of the perineal musculature	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)	3 months
Secondary	King's Health Questionnaire	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	3 months