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Intravaginal Electrical Nerve Stimulation in Women With Non-contracting Pelvic Floor

NCT03319095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-06-18

No results posted yet for this study

Summary

It is estimated that about 30% of women cannot voluntarily contract the pelvic floor muscles (PFM). PFM training (PFMT) represents the first therapeutic option for the treatment of female urinary incontinence (UI), however the inability to contract this muscle makes PFMT unfeasible. The primary objective of this project is to evaluate clinically the efficacy of intravaginal electrical stimulation associated with verbal instructions to provide the ability of women to contract voluntary their PFM. The secondary objective is to evaluate the UI prevalence and impact on quality of life.

Conditions

  • Pelvic Floor
  • Muscle
  • Contraction
  • Electric Stimulation Therapy

Interventions

DEVICE

Intravaginal Electrical Nerve Stimulation

The Intervention group will receive Intravaginal Electrical Nerve Stimulation using Quark® Dualpex equipment, once per week during 8 weeks. The selected current will be biphasic, and the stimulation parameters will be: 50 Hz frequency, pulse width of 200 microseconds, contraction time (Ton) of 5 seconds, relaxation time (Toff) of 10 seconds, intensity of current defined according to the sensitivity (tolerance) of the patient, and total stimulation time of 20 minutes once a week delivered by an experienced Physiotherapist. In the last 10 minutes of each electrical nerve stimulation session women will be requested to perform voluntary PFM contractions along with the contractions induced by the electrical stimulation. Women will not be instructed to perform any aditional exercise or therapy at home.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Cristine HJ Ferreira, PhD · Ribeirão Preto Medical School, University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2020-03-06
Completion
2020-03-06

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03319095 on ClinicalTrials.gov