Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of External Electrical Stimulation Added to Pelvic Floor Muscle Training in Women With Stress Incontinence

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

Intervention / Treatment
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* Behavioral: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)
* Behavioral: External electrical stimulation
* Behavioral: Pelvic floor muscle training (PFMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) group<br>This arm is going to include the patients who are performed external electrical stimulation (EES) added to pelvic floor muscle training (PFMT). | Behavioral: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)<br>* Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session. While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.<br>|
| Other: External electrical stimulation (EES) group<br>This arm is going to include the patients who are performed external electrical stimulation (EES). | Behavioral: External electrical stimulation<br>* Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.<br>|
| Active Comparator: Pelvic floor muscle training (PFMT) group<br>This arm is going to include the patients who are performed pelvic floor muscle training (PFMT). | Behavioral: Pelvic floor muscle training (PFMT)<br>* While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported improvement | Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour pad test | Urinary incontinence severity was assessed. | 8 weeks | 
| pelvic floor muscle strength and endurance | measured using noninvasive vaginal perineometer | 8 weeks |