Clinical trial NCT05399173: 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
Overall status: RECRUITING
Phase: NA
Conditions: Non-Specific Urethritis
Keywords: adolescents, nocturnal enuresis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: bladder capacity
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Maximum voided volume
timeFrame: up to 6 weeks
measure: Frequency of bed wet
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: faculty of physical therapy
name: Mai Mo Shehata, lecturer
role: PRINCIPAL_INVESTIGATOR
References: