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The use of electrical current for pelvic floor muscles in stress urinary loss: a study with cost evaluation

Intravaginal electrostimulation associated with pelvic floor muscle training protocol for women with stress urinary incontinence: a randomized controlled trial with economic evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6gtzg4
Enrollment
120
Registered
2019-11-19
Start date
2023-09-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Stress Urinary Incontinence

Interventions

This is a randomized controlled clinical trial. Blinding will be implemented, with the physiotherapist responsible for assessments being different from the physiotherapist responsible for the interven
pelvic floor muscle assessment by vaginal palpation
Global Perceived Effect Scale
quality of life assessment using the King’s Health Questionnaire, Short Form 6 Dimensions Brazil, and King’s Health Questionnaire Scoring Algorithm
and economic evaluation. In this group, participants will perform pelvic floor muscle training without physiotherapist supervision, using an educational booklet, and will be instructed to perform the
non-polarized current
rectangular waveform
pulse duration of 700 µs
on-time of 5 seconds
off-time ratio of 1:3 during the first five sessions (15 seconds) and 1:2 during the last five sessions (10 seconds)
rise time of 1 second
decay time of 0
frequency of 50 Hz
application time of 20 minutes
and current amplitude adjusted to the maximum tolerated by the participant. Pelvic floor muscle training will be based on the protocol proposed by Bø, Talseth, and Holme and will last 10 weeks as foll
sets: 1 set in each position
repetitions: 8 to 12 contractions, each sustained for 6 to 8 seconds. After these repetitions, 3 to 4 quick contractions will be added. Relaxation time: 6 seconds. Intensity: maximum contraction. A fa

Sponsors

Programa de Pós-Graduação em Fisioterapia da Universidade Federal de São Carlos
Lead Sponsor
Universidade Federal de São Carlos
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Women will be included (biological sex); older than 18 years; who know how to read and write in Portuguese; who are available to provide face to face care in São Carlos; with symptoms of stress urinary incontinence

Exclusion criteria

Exclusion criteria: Participants will be excluded if they have never had sexual activity involving vaginal penetration; are pregnant; are less than 6 months postpartum; present with vaginal or urinary tract infection; have a neurological disease; have cancer in the abdominal or pelvic region; have previously undergone treatment or surgery for urinary incontinence; have a metallic implant or hip and knee limitations; present with pain or discomfort; or are unable to perform pelvic floor muscle contraction

Design outcomes

Primary

MeasureTime frame
To evaluate whether there is a change in quality of life in women after intervention to treat stress urinary incontinence, using the King's Health Questionnaire (KHQ), which consists of 30 questions that evaluate the items health perception, impact of urinary incontinence, limitations of daily activities, physical limitations and social limitations, personal relationships, emotions, sleep and energy, severity measures. The scores of this questionnaire range from 0 to 100, and consider that the higher the score, the worse the quality of life determined for each person. And the Short-Form 6 Dimensions – Brazil (SF-6D) questionnaire, which assesses functional capacity, global limitation, physical aspects, emotional aspects, social aspects, pain, mental health and vitality. Also identify the frequency of urination and frequency of urinary loss through the urination diary and identify whether there is a change in the function of the pelvic floor muscles after treatment through vaginal palpation.—

Secondary

MeasureTime frame
Identify the health costs that will be evaluated by the Short-Form 6 Dimensions - Brazil, as it allows the generation of utility indices (adjusted life years) from the effectiveness data used in economic analysis and has a unique score ranging from 0 to 1. (where 0 represents the worst state of health and 1 represents the best state of health).—

Countries

BR

Contacts

Public ContactIngrid Vilela

Universidade Federal de São Carlos

ingridvilela@estudante.ufscar.br+55(34)992207544

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Sep 19, 2026