Intravaginal Electrical Nerve Stimulation in Women With Non-contracting Pelvic Floor
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|ClinicalTrials.gov Identifier: NCT03319095|
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : July 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Floor Muscle Contraction Electric Stimulation Therapy||Device: Intravaginal Electrical Nerve Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|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|
|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|
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.
- 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.
- 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.
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
|Contact: Favia IA Vassimon, PhDemail@example.com|
|Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto||Recruiting|
|Ribeirão Preto, São Paulo, Brazil, 14620000|
|Contact: Flávia I.A. Vassimon, PhD 16997916188 firstname.lastname@example.org|
|Principal Investigator:||Cristine HJ Ferreira, PhD||Ribeirão Preto Medical School, University of São Paulo|