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Clinical Trials/RBR-103yr8h9
RBR-103yr8h9
Completed
Phase 2

Acute effect of Transcranial Direct Current Stimulation (electrical stimulation applied to the scalp) on the function of contraction (as if holding urine and then relaxing) of pelvic floor muscles (muscles that control urine and stool) in healthy women

Angela Cristina Ledur0 sitesOctober 12, 2023

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
rinary Incontinence
Sponsor
Angela Cristina Ledur
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

ntroduction: Studies have shown that the association of Transcranial Direct Current Stimulation (tDCS) with other therapeutic interventions have neuroplastic effects and lasting clinical improvements after interventions. Objectives: To evaluate the acute effect of tDCS associated with pelvic floor muscle training (PFMT) on pelvic floor muscle strength in healthy women, quality of life and sexual function. Methods: This is a cross-over clinical trial with healthy women. Initially, the volunteers were evaluated regarding demographic data and sexual function and evaluated regarding the function of the Pelvic Floor Muscle (PFM) by the PERFECT scale and intravaginal pressure in initial evaluation and after each intervention. They were randomized for application of tDCS-active and tDCS-sham. For tDCS application, the anode electrode was positioned on the supplementary motor area (AMS), and the cathode on the supraorbital region, with a current intensity of 2Ma. In tDCS-active, current was applied for 20 minutes and in tDCS-sham, current was applied for 30 seconds and turned off for the remainder of the time. Both protocols were associated with TMAP for 10 minutes. Statistical analyzes were performed using the SAS Studio 9.0 program and the Shapiro-Wilk, Mann-Whitney and Wilcoxon tests were used, with a significance level of p=0.05. Results: 20 healthy women, aged 23.4 (±1.7) years, nulliparous and sexually active were included. Compared to the initial assessment, there was a greater number of repetitions of sustained contractions (R) after active tDCS (p=0.00), with a difference in results when comparing the two interventions (p=0.01) and a tendency to improvement in the number of fast contractions (p=0.03) and number of repetitions of sustained contractions (p=0.07) after tDCS-sham. Conclusion: There was an acute effect of tDCS-active in improving the number of repetitions of sustained PFM contractions with a difference in the results obtained compared to tDCS-sham.

Registry
who.int
Start Date
October 12, 2023
End Date
April 1, 2023
Last Updated
2 years ago
Study Type
Intervention
Sex
Female

Investigators

Sponsor
Angela Cristina Ledur

Eligibility Criteria

Inclusion Criteria

  • Healthy women; Nulliparous;18 and 45 years; sexually active in the last four weeks.

Exclusion Criteria

  • Participants who present any type of symptom or conditions that are linked to any change in the bladder, bowel and vagina/pelvis evaluated by the sample characterization form and applied questionnaire; chronic degenerative diseases; neurological disease; psychiatric disease; women who have undergone previous pelvic floor reeducation programs and/or pelvic floor surgeries for treatment of urinary infection or other conditions in the pelvic region; pregnant women; women with pacemaker or present any contraindications to the use of transcranial direct current stimulation; or present anesthesia or hyperesthesia at the transcranial direct current stimulation application site

Outcomes

Primary Outcomes

Not specified

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