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

Cairo University (CU)

Status: Enrolling

Conditions: Non-Specific Urethritis

Treatments: Device: infrared (gallium aluminum arsenide laser); Drug: medical treatment(desmopressin acetate)

Study type: Interventional

Funder types: Other

Identifiers

NCT05399173

P.T.REC/012/003689

Details and patient eligibility

About

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

Full 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 .

Enrollment: 60 estimated patients

Sex: Female

Ages: 10 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

an infrared (gallium aluminum arsenide laser)

Experimental group

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.

Treatment:

Device: infrared (gallium aluminum arsenide laser)

conventional therapy

Active Comparator group

Description:

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

Treatment:

Drug: medical treatment(desmopressin acetate)