Clinical trial NCT04590157: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Neuromodulation
laser acupuncture
neurogenic acupoints
female stress urinary incontinence
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pelvic floor muscle strength (PFMS)
timeFrame: 6 weeks
measure: Stress urinary incontinence (SUI) severity
timeFrame: 6 weeks
measure: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
state: El-Sheikh Zayed City Giza 1133 Egypt
Study officials:
affiliation: lecturer, department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,Egypt
name: Doaa A Osman, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: professor,department of physical therapy for Women's Health faculty of physical therapy ,Cairo university,egypt
name: Khadiga S Abdulaziz
role: STUDY_DIRECTOR
affiliation: Department of Physiotherapy, Ahmed Maher Teaching Hospital, Cairo, Egypt
name: Doha R Ahmed, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, Department of Urology, Ahmed Maher Teaching Hospital, Cairo, Egypt
name: Emad E Atiya, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer, Department of Physical Therapy For Neuromuscular Disorders and its surgery, Faculty of Physical Therapy, October 6 University, Egypt
name: Lama S Mahmoud, PHD
role: PRINCIPAL_INVESTIGATOR
References: