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Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Low Level Laser Therapy
Pelvic floor muscle training
Sponsored by
Lama Saad El-Din Mahmoud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Neuromodulation, laser acupuncture, neurogenic acupoints, female stress urinary incontinence

Eligibility Criteria

30 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • October 6 UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

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

received pelvic floor muscle training

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2020
Last Updated
October 28, 2020
Sponsor
Lama Saad El-Din Mahmoud
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1. Study Identification

Unique Protocol Identification Number
NCT04590157
Brief Title
Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence
Official Title
Neuromodulation Effect of Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lama Saad El-Din Mahmoud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Neuromodulation, laser acupuncture, neurogenic acupoints, female stress urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
received pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints
Arm Title
control group
Arm Type
Experimental
Arm Description
received pelvic floor muscle training
Intervention Type
Device
Intervention Name(s)
Low Level Laser Therapy
Intervention Description
Laser Acupuncture application on Neurogenic Acupoints: the treatment based upon the use of low power laser light to stimulate acupuncture points
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle training
Intervention Description
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
Primary Outcome Measure Information:
Title
Pelvic floor muscle strength (PFMS)
Description
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
Time Frame
6 weeks
Title
Stress urinary incontinence (SUI) severity
Description
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.
Time Frame
6 weeks
Title
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).
Description
it is a validated subjective measure used to assess the Stress urinary incontinence and its impact on quality of life
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lama S Mahmoud, PHD
Phone
01157592636
Email
lamaelsedawyy@hormail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa A Osman, PHD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa A Osman, PHD
Organizational Affiliation
lecturer, department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khadiga S Abdulaziz
Organizational Affiliation
professor,department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Doha R Ahmed, Bachelor
Organizational Affiliation
Department of Physiotherapy, Ahmed Maher Teaching Hospital, Cairo, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emad E Atiya, PHD
Organizational Affiliation
Professor, Department of Urology, Ahmed Maher Teaching Hospital, Cairo, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lama S Mahmoud, PHD
Organizational Affiliation
Lecturer, Department of Physical Therapy For Neuromuscular Disorders and its surgery, Faculty of Physical Therapy, October 6 University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 University
City
Giza
State/Province
El-Sheikh Zayed City Giza 1133 Egypt
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of physical therapy October 6 University
Phone
0238362496
Email
pt@o6u.edu.eg

12. IPD Sharing Statement

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Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence

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