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Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females

Primary Purpose

Non-Specific Urethritis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
infrared (gallium aluminum arsenide laser)
medical treatment(desmopressin acetate)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Specific Urethritis focused on measuring adolescents, nocturnal enuresis

Eligibility Criteria

10 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adolescent females have to meet the following criteria in order to participate in this study:

    • Suffering from Monosymptomatic nocturnal enuresis.
    • Their ages will range from 10-18 years.
    • Resistance to medical treatment (desmopressin acetate)

Exclusion Criteria:

  • Adolescent Females with the following criteria will be excluded from this study:

    • Psychological or neurological disorders or other organic disorders.
    • Any chronic diseases.
    • Spinal cord abnormalities associated neurogenic bladder.
    • Evidence of urinary tract infection.
    • Ectopic ureter In addition, chronic constipation or encopresis.

Sites / Locations

  • Faculty of physical therapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

an infrared (gallium aluminum arsenide laser)

conventional therapy

Arm Description

Each female in study group will be treated by laser acupuncture for 3 sessions per week, for 6 weeks. An infrared (gallium aluminum arsenide) laser will be used at a wavelength of 808 nm and a power of 200 m W applied for 26 s to produce energy of less than 4 J/cm. participants will receive the same medical treatment (desmopressin acetate) and advice as in control group in addition to low level laser therapy 3 session / week for 6 weeks.

They will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) & advice.

Outcomes

Primary Outcome Measures

bladder capacity
Sonography for bladder capacity. It will be used to determine bladder capacity for all participants before the beginning of the study for both groups, and at end of the study

Secondary Outcome Measures

Maximum voided volume
will be measured in all participants. using a voiding diary over 4 days before starting therapy for each female in both group A and B and after the treatment program.
Frequency of bed wet
It will be used to determine the number of bed wet for each female in both group A and B before and after the treatment program.

Full Information

First Posted
May 23, 2022
Last Updated
August 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05399173
Brief Title
Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females
Official Title
Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
September 8, 2023 (Anticipated)
Study Completion Date
September 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

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
The aim of this study is to evaluate the effect of laser acupuncture on monosymptomatic nocturnal enuresis in adolescent females.
Detailed Description
Nocturnal enuresis (NE) can be defined as the involuntary passage of urine during sleep beyond the age of anticipated nighttime bladder control, which is generally accepted as 5 years of age. IF neglected may persist into adulthood and be associated with urgency incontinence . It causes social, psychological, and emotional distress and carries a significant clinical burden. Studies show that enuretic children have lower self-esteem than healthy children. Even among chronic illnesses, enuresis has more negative effect on children's mental and social health . Most of the studies highlighted that persisting NE was a high risk of psychosocial comorbidity and negatively affects the quality of life. The feeling of helplessness of enuretic patients highlights the magnitude and complexity of the problem. Persisting enuresis adversely affects the coping, social competence, and school performance of enuretic patients when compared to their normal peers. Furthermore, a negative correlation exists between the self-esteem of an enuretic child and the chance of treatment failure . Complementary and alternative medicine (CAM) widely helped to encounter the increasing demand for non-pharmacological approaches. In recent years, there is a focus on finding cost-effective therapeutic approaches with minimal side effects to treat nocturnal enuresis . Regarding the effect of laser acupuncture on nocturnal enuresis, previous studies about the effect of low level laser acupuncture on monosymptomatic nocturnal enuresis females are limited. There was only one previous study that examined the effect of low level laser acupuncture on bladder reservoir . This study will be the first one to objectively assess the effect of laser acupuncture in monosymptomatic nocturnal enuresis by sonography. As a result, this study will have variable benefits for medical care organizations and will add to the body of knowledge of physical therapists in the scientific domain. Control group will consist of 30 females. participants will receive medical treatment (desmopressin acetate, ) per-night dose of 120 g (for 6 weeks) & advice . Study group will consist of 30 females. participants will receive the same medical treatment and advice as in group (A) in addition to low level laser therapy 3 session / week for 6 weeks. All participants will be given a full explanation of the protocol of the study and an informed consent form will be signed by each female before participating in the study .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Specific Urethritis
Keywords
adolescents, nocturnal enuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
an infrared (gallium aluminum arsenide laser)
Arm Type
Experimental
Arm Description
Each female in study group will be treated by laser acupuncture for 3 sessions per week, for 6 weeks. An infrared (gallium aluminum arsenide) laser will be used at a wavelength of 808 nm and a power of 200 m W applied for 26 s to produce energy of less than 4 J/cm. participants will receive the same medical treatment (desmopressin acetate) and advice as in control group in addition to low level laser therapy 3 session / week for 6 weeks.
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
They will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) & advice.
Intervention Type
Device
Intervention Name(s)
infrared (gallium aluminum arsenide laser)
Intervention Description
Patient Position will be in supine & prone position, the area of these points is resolved utilizing anatomical landmarks and an arrangement of length measurements whose units are in respect to the physical extents of the individual patient. Acupuncture points used to treat nighttime enuresis are situated in regions that coincide with innervation by spinal sacral segments S2 through to S4 and expressed in the treatment conventions. The points of BL 23, BL 28, BL 32, RN 3, RN 4, RN 6, RN 12 impact the spinal micturition centers and parasympathetic innervation to the urinary tract, while excitement on scalp acupoints of DU 20 and DU 14 change cerebrum function through inner temporal, thalamencephalon and prefrontal cortical frameworks. Excitation of acupoints UB 20, UB 13, SP 6, ST 36, KI 3 and LU 9 are considered to strengthen spleen, vital energy and blood which encourage standardized bladder capacity
Intervention Type
Drug
Intervention Name(s)
medical treatment(desmopressin acetate)
Intervention Description
participants will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) & advice
Primary Outcome Measure Information:
Title
bladder capacity
Description
Sonography for bladder capacity. It will be used to determine bladder capacity for all participants before the beginning of the study for both groups, and at end of the study
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Maximum voided volume
Description
will be measured in all participants. using a voiding diary over 4 days before starting therapy for each female in both group A and B and after the treatment program.
Time Frame
up to 6 weeks
Title
Frequency of bed wet
Description
It will be used to determine the number of bed wet for each female in both group A and B before and after the treatment program.
Time Frame
up to 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescent females have to meet the following criteria in order to participate in this study: Suffering from Monosymptomatic nocturnal enuresis. Their ages will range from 10-18 years. Resistance to medical treatment (desmopressin acetate) Exclusion Criteria: Adolescent Females with the following criteria will be excluded from this study: Psychological or neurological disorders or other organic disorders. Any chronic diseases. Spinal cord abnormalities associated neurogenic bladder. Evidence of urinary tract infection. Ectopic ureter In addition, chronic constipation or encopresis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jehan Hu Mustafa, demonstrator
Phone
01063299714
Email
jejemustafa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jehan Hu Mustafa, demonstrator
Phone
01063299714
Email
gehan.hussien@merit.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Mo Shehata, lecturer
Organizational Affiliation
faculty of physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jehan Mustafa, Master
Phone
01063299714
Email
jejemustafa@gmail.com

12. IPD Sharing Statement

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Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females

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