Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence

NCT04590157 | Unknown

• 1 other identifier: P.T. REC/012/002930
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress Urinary Incontinence

Keywords

Neuromodulation; laser acupuncture; neurogenic acupoints; female stress urinary incontinence

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

study group

EXPERIMENTAL

received pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints

Device: Low Level Laser Therapy; Other: Pelvic floor muscle training

control group

EXPERIMENTAL

received pelvic floor muscle training

Other: Pelvic floor muscle training

Interventions

Low Level Laser Therapy DEVICE

Laser Acupuncture application on Neurogenic Acupoints: the treatment based upon the use of low power laser light to stimulate acupuncture points

study group

Pelvic floor muscle training OTHER

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

control group; study group

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lama Saad El-Din Mahmoud: lead

Study Sites (1)

October 6 University

Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Doaa A Osman, PHD

  lecturer, department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,Egypt

  PRINCIPAL INVESTIGATOR

• Khadiga S Abdulaziz

  professor,department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,egypt

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lama S Mahmoud, PHD

CONTACT

01157592636; lamaelsedawyy@hormail.com

Doaa A Osman, PHD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Model Details: the control group received pelvic floor muscle training ,and the study group received the same program in addition to laser acupuncture on neurogenic acupoints

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: October 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 30, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

EG (1)