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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05399173

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effect of laser acupuncture on monosymptomatic nocturnal enuresis in adolescent females.

Condition or Disease	Intervention/Treatment	Phase
Non-Specific Urethritis	Device: infrared (gallium aluminum arsenide laser) Drug: medical treatment(desmopressin acetate)	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 2, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: an infrared (gallium aluminum arsenide laser) 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.	Device: infrared (gallium aluminum arsenide laser) 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
Active Comparator: conventional therapy They will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) & advice.	Drug: medical treatment(desmopressin acetate) participants will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) & advice

Arm

Intervention/Treatment

Experimental: an infrared (gallium aluminum arsenide laser)

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.

Device: infrared (gallium aluminum arsenide laser)

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

Active Comparator: conventional therapy

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

Drug: medical treatment(desmopressin acetate)

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

Outcome Measures

Primary Outcome Measures

bladder capacity [up to 6 weeks]
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 [up to 6 weeks]
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 [up to 6 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

Female

Accepts 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.