Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- bladder capacity
研究概览
简要总结
The aim of this study is to evaluate the effect of laser acupuncture on monosymptomatic nocturnal enuresis in adolescent females.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: infrared (gallium aluminum arsenide laser) (Device)
conventional therapy
They will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) & advice.
干预措施: medical treatment(desmopressin acetate) (Drug)
结局指标
主要结局
bladder capacity
时间窗: 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
次要结局
- Frequency of bed wet(up to 6 weeks)
- Maximum voided volume(up to 6 weeks)
研究者
Jehan Hussien Mohammed Mustafa
principle investigator
Cairo University