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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04590157
Other study ID # P.T. REC/012/002930
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date December 30, 2020

Study information

Verified date October 2020
Source October 6 University
Contact Lama S Mahmoud, PHD
Phone 01157592636
Email lamaelsedawyy@hormail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 30, 2020
Est. primary completion date December 15, 2020
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 45 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
Egypt October 6 University Giza El-Sheikh Zayed City Giza 1133 Egypt

Sponsors (1)

Lead Sponsor Collaborator
Lama Saad El-Din Mahmoud

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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