Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence

Study Overview
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Brief Summary
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background:Stress urinary incontinence (SUI) is the most common type of urinary incontinence in women, as it involves involuntary leakage of urine , the current study was To determine the neuromodulation effect of Laser Therapy on Neurogenic Acupoints in female with stress urinary incontinence (SUI).

Detailed Description
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Thirty women with SUI were randomly divided into two equal groups; the control group received pelvic floor muscle training , while the study group received the same pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints . The outcome measures were pelvic floor muscle strength (PFMS) , SUI severity assessed by Severity Index (SI) , and Incontinence Questionnaire-Short Form (ICIQ-SF). The outcome measures were assessed pre- and post-rehabilitation program.

Official Title
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Neuromodulation Effect of Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Low Level Laser Therapy
* Other: Pelvic floor muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ranged from 30 to 45 years old body mass index (BMI) was less than 30 kg/m2, all women were non-smokers and they had a sedentary life style Exclusion Criteria: The participants were excluded if they had other types of urinary incontinence (urge or mixed) urinary tract infection pelvic organ prolapse diabetes mellitus respiratory diseases, chronic cough and constipation

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 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
Interventional Model Description: the control group received pelvic floor muscle training ,and the study group received the same program in addition to laser acupuncture on neurogenic acupoints
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>received pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints | Device: Low Level Laser Therapy<br>* Laser Acupuncture application on Neurogenic Acupoints: the treatment based upon the use of low power laser light to stimulate acupuncture points<br>Other: Pelvic floor muscle training<br>* exercise prodram as follow: from supine lying position with legs slightly apart the patient asked to contract the pelvic muscles as hard as possible and hold for 10 seconds<br>|
| Experimental: control group<br>received pelvic floor muscle training | Other: Pelvic floor muscle training<br>* exercise prodram as follow: from supine lying position with legs slightly apart the patient asked to contract the pelvic muscles as hard as possible and hold for 10 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength (PFMS) | The pelvic floor muscle strength of all women in both groups was assessed pre- and post-rehabilitation program, using XFT-0010 Pelvic Muscle Trainer device | 6 weeks | 
| Stress urinary incontinence (SUI) severity | The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe. | 6 weeks | 
| International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). | it is a validated subjective measure used to assess the Stress urinary incontinence and its impact on quality of life | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromodulation, laser acupuncture, neurogenic acupoints, female stress urinary incontinence