Electrostimulation PROTOCOL Incontinence

NCT ID: NCT03682926

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

Brief 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)

Detailed 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).

Conditions

Female Stress Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

electrostimulation individualized

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.

Group Type: EXPERIMENTAL

Electro-stimulation

Intervention Type: OTHER

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

electrostimulation with fixed protocol

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.

Group Type: ACTIVE_COMPARATOR

Electro-stimulation

Intervention Type: OTHER

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

Interventions

Electro-stimulation

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

Intervention Type: OTHER

Other Intervention Names

electro physical therapy; dualpex 961 quark

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitário Professor Edgard Santos

OTHER

Sponsor Role: lead

Responsible Party

ROSANA CRISTINA PEREIRA DE ANDRADE

Dra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ROAND2015

Identifier Type: -

Identifier Source: org_study_id