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Neuromodulation Effect of Laser Acupuncture on Stress Urinary Incontinence

NCT ID: NCT04590157

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Stress Urinary Incontinence

Keywords

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Neuromodulation laser acupuncture neurogenic acupoints female stress urinary incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

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

Group Type EXPERIMENTAL

Low Level Laser Therapy

Intervention Type DEVICE

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

Pelvic floor muscle training

Intervention Type 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

received pelvic floor muscle training

Group Type EXPERIMENTAL

Pelvic floor muscle training

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lama Saad El-Din Mahmoud

OTHER

Sponsor Role lead

Responsible Party

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Lama Saad El-Din Mahmoud

Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Doaa A Osman, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Khadiga S Abdulaziz

Role: STUDY_DIRECTOR

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

Doha R Ahmed, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Department of Physiotherapy, Ahmed Maher Teaching Hospital, Cairo, Egypt

Emad E Atiya, PHD

Role: PRINCIPAL_INVESTIGATOR

Professor, Department of Urology, Ahmed Maher Teaching Hospital, Cairo, Egypt

Lama S Mahmoud, PHD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Department of Physical Therapy For Neuromuscular Disorders and its surgery, Faculty of Physical Therapy, October 6 University, Egypt

Locations

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October 6 University

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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Lama S Mahmoud, PHD

Role: CONTACT

Phone: 01157592636

Email: [email protected]

Doaa A Osman, PHD

Role: CONTACT

Facility Contacts

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faculty of physical therapy October 6 University

Role: primary

Other Identifiers

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P.T. REC/012/002930

Identifier Type: -

Identifier Source: org_study_id