Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

Giresun University

Status: Completed

Conditions: Urinary Incontinence, Stress; Pelvic Floor Disorders; Electrical Stimulation; Urinary Incontinence

Treatments: Behavioral: External electrical stimulation; Behavioral: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT); Behavioral: Pelvic floor muscle training (PFMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04792125

2019-55

Details and patient eligibility

About

In this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.

Full description

Fifty one women with mild and moderate SUI symptoms were included in the study. The patients were divided into three groups of PFMT (n:17), EES (n:17) and PFMT+ EES (n:17) by block randomization. The PFMT was applied every day of the week, and EES was applied 3 days a week for 8 weeks. Pelvic floor muscle strength (PFMS), pelvic floor muscle endurance, subjective perception of improvement, severity of incontinence, quality of life, pelvic floor dysfunction (PTD) and urinary parameters were assessed as outcome variables. All measurements, except subjective perception of improvement were investigated before and after treatment.

Enrollment: 51 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• having symptoms of pure stress urinary incontinence and stress predominant UI
• ability to contract pelvic floor muscle strength
• Having a mild or moderate SUI symptom according to the 24-hour pad test results.

Exclusion criteria

• Pregnancy,
• Having been treated for incontinence within a period of six months ago,
• Not being able to cooperate,
• Presence of urinary infection
• Use of metal implants or cardiac pacemakers,
• Epilepsy,
• Presence of stage 3 or 4 pelvic organ prolapse,
• Presence of accompanying neurological disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups

External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) group

Experimental group

Description:

This arm is going to include the patients who are performed external electrical stimulation (EES) added to pelvic floor muscle training (PFMT).

Treatment:

Behavioral: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)

External electrical stimulation (EES) group

Other group

Description:

This arm is going to include the patients who are performed external electrical stimulation (EES).

Treatment:

Behavioral: External electrical stimulation

Pelvic floor muscle training (PFMT) group

Active Comparator group

Description:

This arm is going to include the patients who are performed pelvic floor muscle training (PFMT).

Treatment:

Behavioral: Pelvic floor muscle training (PFMT)