Muscle Clinical Trial
Official title:
Intravaginal Electrical Nerve Stimulation to Achieve a Voluntary Contraction in Women With Non-contracting Pelvic Floor: a Randomized Controlled Trial
Verified date | June 2020 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | March 6, 2020 |
Est. primary completion date | March 6, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bidigital Vaginal Palpation | 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. |
30 minutes | |
Secondary | International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) | 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. | 20 minutes |
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