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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03319095
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Flávia Ignácio Antônio Vassimon, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Floor Muscle Contraction Electric Stimulation Therapy Device: Intravaginal Electrical Nerve Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The main investigators and assessor will be blinded in relation to the allocation of participants in the groups
Primary Purpose: Treatment
Official Title: Intravaginal Electrical Nerve Stimulation to Achieve a Voluntary Contraction in Women With Non-contracting Pelvic Floor: a Randomized Controlled Trial
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
No Intervention: Control
Control group: participants will receive only verbal instructions on PFM anatomy and function during the first assessment when women will be required to contract their pelvic floor muscle. The participants will have no contact with the service until the second assessment
Active Comparator: Intervention
Intravaginal Electrical Nerve Stimulation: participants will be submitted to Intravaginal Electrical Nerve Stimulation
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.




Primary Outcome Measures :
  1. Bidigital Vaginal Palpation [ Time Frame: 30 minutes ]

    The primary outcome will be assessed by bidigital vaginal palpation using the modified Oxford scale at baseline and after 10 weeks. The correct contraction of the PFM will be considered as the action of occlusion and elevation of the PFM around the examiner's fingers in the ventral and cranial directions. Therefore, it will be considered a clinically relevant improvement to obtain a score above 3 on the modified Oxford scale.

    The examination will be performed following the following steps:

    • The participant will receive information about the procedure, and basic anatomy of the PFM.
    • She will be placed in dorsal decubitus, with hips and knees flexed, feet supported and legs apart;
    • The examiner using a procedure glove will carefully insert the index and middle fingers into the vaginal canal;
    • The participant will be instructed to contract the PFM in order to raise and compress the examiner's fingers.
    • To conclude, the participant will be directed to completely relax the PFM.


Secondary Outcome Measures :
  1. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) [ Time Frame: 20 minutes ]
    Reports of urinary incontinence (UI) will be evaluated through the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)at baseline and after 10 weeks. This questionnaire was translated and validated into the Portuguese language by Tamanini et al. (2004), and evaluates the symptoms, severity of UI, and the impact that UI has on women's quality of life (QoL). It is a brief questionnaire and the purpose of its use is to facilitate the comparison of data from different studies and to enable a more consistent and unified assessment of UI symptoms and its repercussion in QoL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who are routinely referred to the Lucy Montoro Rehabilitation Center of the Hospital das Clínicas of the University of São Paulo at Ribeirão Preto Medical School - HCFMRP-USP for the physiotherapeutic treatment of pelvic floor dysfunctions;
  • Pelvic floor muscle function grade 0 (zero) or 1 evaluated by bidigital palpation (Modified Oxford Scale);
  • Consent to participate in the study and signing of the free and informed consent form.

Exclusion Criteria:

  • Women with associated neurological pathologies;
  • Symptoms of vaginal or urinary tract infection;
  • Prolapses classified above grade 2;
  • Suspected or confirmed pregnancy and cognitive deficit that compromises the procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319095


Contacts
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Contact: Favia IA Vassimon, PhD 5516997916188 flaviaig@yahoo.com.br

Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Recruiting
Ribeirão Preto, São Paulo, Brazil, 14620000
Contact: Flávia I.A. Vassimon, PhD    16997916188    flaviaig@yahoo.com.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Cristine HJ Ferreira, PhD Ribeirão Preto Medical School, University of São Paulo

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Responsible Party: Flávia Ignácio Antônio Vassimon, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03319095    
Other Study ID Numbers: 73055317.8.0000.5440
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flávia Ignácio Antônio Vassimon, University of Sao Paulo:
pelvic floor, muscle, electrical stimulation, physiotherapy