Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04590157
• Other study ID #: P.T. REC/012/002930
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

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