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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-103yr8h9

Enrollment

Unknown

Registered

2023-10-12

Start date

2022-09-05

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Interventions

This is a double-blind, randomized, sham-controlled study, to assess the acute effect of Transcranial Direct Current Stimulation (tDCS) in pelvic floor muscle strength. 20 healthy, nulliparous women a

E02.331.750

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: It is expected that it will be possible to observe an acute positive effect of tDCS-active associated with pelvic floor muscle training (PFMT) on pelvic floor muscle strength in healthy women. That is, an increase in power (P), endurance (E), number of sustained contractions (R) and fast contractions (F) of pelvic floor function after active-tDCS, is expected to be different from that found in sham-tDCS.;Outcome found 1 (main findings): As final results of pelvic floor muscle function, in item P (strength) they presented a median of 4 [2.0-4.0] and 3.5 [3.0-4.0], in item E (endurance) 3[2.0-6.0] and 3[2.0-4.0], in item R (repetition) 3[3.0-4.0] and 4 [3.0-5, 0], in item F (fast) 9.5 [7.5-10.0] and 9 [6.5-10.0] in tDCS-sham and tDCS-active group respectively. In the final result, there was a difference between the groups in the number of repetitions (item R) (p=0.03). When comparing the pre and post result in the two groups in the item number of repetitions (item R) a difference was also found (p=0.06). There was no difference for the other investigated variables. That is, there was an acute positive effect of active tDCS on the number of repetitions (item R) of the function of the pelvic floor muscles.	—

Measure

Time frame

Expected outcome 1: It is expected that it will be possible to observe an acute positive effect of tDCS-active associated with pelvic floor muscle training (PFMT) on pelvic floor muscle strength in healthy women. That is, an increase in power (P), endurance (E), number of sustained contractions (R) and fast contractions (F) of pelvic floor function after active-tDCS, is expected to be different from that found in sham-tDCS.;Outcome found 1 (main findings): As final results of pelvic floor muscle function, in item P (strength) they presented a median of 4 [2.0-4.0] and 3.5 [3.0-4.0], in item E (endurance) 3[2.0-6.0] and 3[2.0-4.0], in item R (repetition) 3[3.0-4.0] and 4 [3.0-5, 0], in item F (fast) 9.5 [7.5-10.0] and 9 [6.5-10.0] in tDCS-sham and tDCS-active group respectively. In the final result, there was a difference between the groups in the number of repetitions (item R) (p=0.03). When comparing the pre and post result in the two groups in the item number of repetitions (item R) a difference was also found (p=0.06). There was no difference for the other investigated variables. That is, there was an acute positive effect of active tDCS on the number of repetitions (item R) of the function of the pelvic floor muscles.

—

Secondary

Measure	Time frame
The secondary outcome of this study is intravaginal pressure, assessed using a perineometer (Peritron). In lithotomy position, the intravaginal probe with condom will be inserted into the vaginal canal and inflated for coaptation with the vaginal wall. The volunteer will be asked for 3 sustained contractions, the peak value (cmH2O) will be noted and the average of the three contractions will be used. It is expected that after active tDCS increases intravaginal pressure.;Outcome found 2: The intravaginal pressure found in the initial evaluation was 10.8 cmH2O. After tDCS-active and tDCS-sham it was found 11.2 and 12.2cmH2), respectively. No statistical difference between interventions (p>0.05).	—

Measure

Time frame

The secondary outcome of this study is intravaginal pressure, assessed using a perineometer (Peritron). In lithotomy position, the intravaginal probe with condom will be inserted into the vaginal canal and inflated for coaptation with the vaginal wall. The volunteer will be asked for 3 sustained contractions, the peak value (cmH2O) will be noted and the average of the three contractions will be used. It is expected that after active tDCS increases intravaginal pressure.;Outcome found 2: The intravaginal pressure found in the initial evaluation was 10.8 cmH2O. After tDCS-active and tDCS-sham it was found 11.2 and 12.2cmH2), respectively. No statistical difference between interventions (p>0.05).

—

Countries

Brazil

Contacts

Public ContactAngela Ledur

Hospital Universitário da Universidade Estadual de Londrina HU-UEL

angelaledur@hotmail.com+55 95 984177420

Outcome results

None listed

Source: REBEC (via WHO ICTRP)