Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Urinary Incontinence

Treatments: Other: Transvaginal Electrical Stimulation; Other: Vibratory Perineal Stimulus

Study type: Interventional

Funder types: Other

Identifiers

NCT03273309

16-0064

Details and patient eligibility

About

Aim: To compare the effects of Vibratory Perineal Stimulus with transvaginal electrical stimulation to the pelvic floor muscles functionality in women with urinary incontinence and who are unable to voluntarily contract their pelvic floor muscles.

Study Design: Randomized controlled trial

Full description

• The purpose of this study is to find out the effect of vibratory perineal stimulus compared to transvaginal electrical stimulation on the functionality of pelvic floor muscles in women with urinary incontinence who are unable to perform voluntary contraction of this musculature.
• Study Design: Randomized controlled trial
• Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed.and in the Clinical Research Center of the same hospital.
• Inclusion criteria: women with urinary incontinence with zero or one strength degree of pelvic floor muscle contraction by the Modified Oxford Scale.
• Main outcome: Improvement the functionality of pelvic floor muscles
• Secondary outcome: Improvement of urinary loss
• First protocol: patients will be referred by the medical team and will undergo physiotherapeutic evaluation to collect personal data, check the symptoms of urinary incontinence, apply a quality of life questionnaire and measure pelvic floor muscles strength. If patient has zero or one degree of pelvic floor muscle strength, will be referred to the second phase.
• Second protocol: Patients will be randomized into two groups - Vibratory stimulus group or electrical stimulation group. Both will follow a 6-week treatment protocol with intervention once a week. Both are intravaginal devices applied for 20 minutes, with on cycle of 8 seconds and off cycle of 16 seconds.
• Final protocol: patients will repeat the initial evaluation.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of urinary incontinence;
• To be unable to perform a voluntarily contraction of pelvic floor muscles;
• Understand the instruments used in the research;

Exclusion criteria

• Allergy to latex;
• Individual or group pelvic floor muscle training in the last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Vibratory Perineal Stimulus

Active Comparator group

Description:

It's thought that the vibratory perineal stimulation can produces afferent nerve impulses that goes to the sacral spinal cord (S2-S4) via the pudendal nerve and stimulates the sacral somatic response which will cause the pelvic muscle contraction.

Treatment:

Other: Vibratory Perineal Stimulus

Transvaginal Electrical Stimulation

Active Comparator group

Description:

Transvaginal electrical stimulation can produces direct and reflex responses of the pelvic floor muscles, being more effective in patients who can't voluntarily contract this musculature. In addition, it increases blood flow to the muscles, restores neuromuscular connections and improves muscle fiber function.

Treatment:

Other: Transvaginal Electrical Stimulation