Electrostimulation PROTOCOL Incontinence

NCT03682926 | Completed

• 1 other identifier: ROAND2015
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Female Stress Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• King's Health Questionnaire

  3 months

Study Arms (2)

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.

Other: Electro-stimulation

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.

Other: Electro-stimulation

Interventions

Electro-stimulation OTHER

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

Also known as: electro physical therapy, dualpex 961 quark

electrostimulation individualized; electrostimulation with fixed protocol

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitário Professor Edgard Santos: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: September 25, 2018
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share