Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence

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

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).

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Low Level Laser Therapy; Other: Pelvic floor muscle training

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Sheikh Zayed City Giza 1133 Egypt
    • Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt
      • Recruiting
      • October 6 University
      • Contact: faculty of physical therapy October 6 University; Phone Number: 0238362496; Email: pt@o6u.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: study group; received pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints	Device: Low Level Laser Therapy; Laser Acupuncture application on Neurogenic Acupoints: the treatment based upon the use of low power laser light to stimulate acupuncture points; Other: Pelvic floor muscle training; 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
EXPERIMENTAL: control group; received pelvic floor muscle training	Other: Pelvic floor muscle training; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lama Saad El-Din Mahmoud
• Investigators: Principal Investigator: Doaa A Osman, PHD, lecturer, department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,Egypt; Study Director: Khadiga S Abdulaziz, professor,department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,egypt; Principal Investigator: Doha R Ahmed, Bachelor, Department of Physiotherapy, Ahmed Maher Teaching Hospital, Cairo, Egypt; Principal Investigator: Emad E Atiya, PHD, Professor, Department of Urology, Ahmed Maher Teaching Hospital, Cairo, Egypt; Principal Investigator: Lama S Mahmoud, PHD, Lecturer, Department of Physical Therapy For Neuromuscular Disorders and its surgery, Faculty of Physical Therapy, October 6 University, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2020
• Primary Completion (ANTICIPATED): December 15, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Neuromodulation; laser acupuncture; female stress urinary incontinence; neurogenic acupoints
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: P.T. REC/012/002930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No