An interventional study of Standard urotherapy, Alarm therapy and Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation in Primary Monosymptomatic Nocturnal Enuresis, sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
This study will evaluate whether adding individualized pelvic floor muscle rehabilitation to standard urotherapy and alarm treatment improves bedwetting in children aged 5-18 years with primary monosymptomatic nocturnal enuresis.
Participants will be randomly assigned to two groups. Both groups will receive standard urotherapy and alarm treatment. One group will also receive pelvic floor muscle rehabilitation for 12 weeks. The study will compare dry nights, alarm activations, and changes in pelvic floor muscle function between the groups.
The International Children's Continence Society (ICCS) defines nocturnal enuresis (NE) as involuntary urinary leakage during sleep in children aged five years or older. Enuresis is a common chronic condition in childhood, and a higher frequency of bedwetting has been associated with a lower likelihood of spontaneous resolution.
Nocturnal enuresis may be primary or secondary. Primary NE refers to children who have never achieved at least six consecutive months of nighttime dryness, whereas secondary NE refers to the recurrence of bedwetting after a dry period of at least six months. Primary NE may be associated with delayed maturation of the central nervous system, genetic factors, nocturnal polyuria, reduced bladder capacity, nocturnal detrusor overactivity, and failure to awaken in response to bladder signals during sleep. Secondary NE may occur in association with underlying medical conditions or psychological stressors. Clinically, NE is classified as monosymptomatic or nonmonosymptomatic. Nonmonosymptomatic enuresis is accompanied by additional lower urinary tract symptoms, such as urgency, daytime urinary incontinence, and voiding difficulties.
Although the pathophysiology of enuresis has not been fully elucidated, it is considered to result from the interaction of multiple factors rather than a single cause. Treatment includes pharmacological and nonpharmacological approaches individualized according to the subtype and severity of enuresis, the child's age, and the motivation and adherence of the child and family. Desmopressin is used to reduce nighttime urine production, particularly in children with nocturnal polyuria and normal bladder capacity. Anticholinergic medications may be combined with other treatments in selected resistant cases to address nocturnal detrusor overactivity. Tricyclic antidepressants may be considered by specialists in refractory cases when other treatments have failed or are contraindicated, but their use is limited by potentially serious adverse effects.
Nonpharmacological approaches include standard urotherapy, motivational therapy, bedwetting alarms, and pelvic floor muscle rehabilitation. Initial management includes education for the child and family, modification of voiding habits, and lifestyle advice. Bedwetting alarms provide an audible signal when urinary leakage occurs during sleep. Although their mechanism of action is not fully understood, alarm treatment is thought to involve conditioning to nighttime bladder signals and inhibition of the voiding reflex. Alarm treatment can provide sustained improvements and has been associated with lower relapse rates than some other treatment approaches.
Pelvic floor muscle rehabilitation is a targeted approach intended to improve children's awareness of pelvic floor muscle contraction and relaxation. It has been investigated as a behavioral and exercise-based intervention for enuresis. One proposed rationale is that pelvic floor muscle overactivity and connective tissue weakness may contribute to enuresis and daytime urinary incontinence by affecting the control of the voiding reflex. Reduced lumbopelvic muscle endurance, stability, and mobility have also been reported in children and adolescents with enuresis compared with asymptomatic individuals. These findings suggest that the lumbopelvic region, including the pelvic floor muscles, may warrant consideration during assessment and treatment.
Studies investigating pelvic floor muscle training, exercise-based approaches, and biofeedback have reported reductions in bedwetting frequency. However, intervention protocols and reported treatment outcomes vary, and no standardized exercise protocol has been established for enuresis.
Although standard urotherapy and alarm treatment are established components of PMNE management, some children require additional treatment. Evidence regarding the additional benefit of pelvic floor muscle rehabilitation alongside these approaches remains limited. Therefore, this study aims to evaluate whether adding pelvic floor muscle rehabilitation to standard urotherapy and alarm treatment over 12 weeks improves treatment outcomes in children with primary monosymptomatic nocturnal enuresis.
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Exclusion Criteria:
Participants will receive standard urotherapy, alarm therapy, and pelvic floor muscle rehabilitation for 12 weeks.
Behavioral: Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation
Participants will receive standard urotherapy and alarm therapy for 12 weeks.
Behavioral: Standard urotherapy, Alarm therapy
Participants will receive standard urotherapy and alarm therapy for 12 weeks.
Participants will receive standard urotherapy, alarm therapy, and pelvic floor muscle rehabilitation for 12 weeks.
Number of Dry Nights
The number of nights without involuntary urine leakage during sleep will be recorded by parents using an enuresis diary.
Time frame: Baseline and weeks 4, 8, and 12.
Number of Enuresis Alarm Activations
The number of moisture-triggered enuresis alarm activations during sleep will be recorded by parents using an enuresis diary.
Time frame: Baseline and weeks 4, 8, and 12.
Treatment Response According to ICCS Criteria
Treatment response will be classified according to the percentage reduction in wet nights from baseline: no response (\<50% reduction), partial response (50-99% reduction), or complete response (100% reduction).
Time frame: Baseline and weeks 12.
Dysfunctional Voiding and Incontinence Scoring System (DVISS) Score
Urinary symptoms and their impact on quality of life will be assessed using the DVISS. Total scores range from 0 to 35, with higher scores indicating greater symptom severity.
Time frame: Baseline and weeks 4, 8, and 12.
Nocturnal Enuresis Symptom Score (NESS)
The severity of nocturnal enuresis symptoms will be assessed using the Nocturnal Enuresis Symptom Score (NESS). Total scores range from 0 to 27, with higher scores indicating greater symptom severi
Time frame: Baseline and weeks 4, 8, and 12.
Plan to share: No
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Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 27 months after the start.
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