Acute effect of Electrical Stimulation applied to the scalp on pelvic floor muscle contraction function in healthy wome

Phase 2

• Conditions: rinary Incontinence; C12.050.351.625

• Registration Number: RBR-103yr8h9
• Lead Sponsor: Angela Cristina Ledur

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-04-01
• Study Start: 2023-10-12
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified