Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence

Not Applicable

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Low Level Laser Therapy; Other: Pelvic floor muscle training

• Registration Number: NCT04590157
• Lead Sponsor: Lama Saad El-Din Mahmoud

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study Start: 2020-10-15
• Study First Posted: 2020-10-19
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-30
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Low Level Laser Therapy	received pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints
study group	Pelvic floor muscle training	received pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints
control group	Pelvic floor muscle training	received pelvic floor muscle training

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength (PFMS)	6 weeks	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
Stress urinary incontinence (SUI) severity	6 weeks	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.
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).	6 weeks	it is a validated subjective measure used to assess the Stress urinary incontinence and its impact on quality of life

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt