ClinicalTrials.gg
RecruitingNCT07890194Updated Oct 22, 2026

Effectiveness of Individualized Pelvic Floor Muscle Rehabilitation in Addition to Standard Urotherapy and Alarm Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis

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

From the registry’s dates

  • Started Aug 2026; still recruiting 1 month later.
Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Primary Monosymptomatic Nocturnal Enuresis
03

In context

Lead sponsor

Hacettepe University is the lead sponsor of 1,001 studies on the registry; 215 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of primary monosymptomatic nocturnal enuresis (PMNE) according to the International Children's Continence Society (ICCS) diagnostic criteria.
  • Age between 5 and 18 years.
  • Willingness to participate in the study and provision of written informed consent by a parent or legal guardian.
  • Recommendation of enuresis alarm therapy as a first-line treatment.

Exclusion criteria

Exclusion Criteria:

  • Presence of cognitive or intellectual impairment.
  • Enuresis attributable to anatomical or neurological causes.
  • Receipt of nonpharmacological treatment for enuresis, such as standard urotherapy, alarm therapy, pelvic floor muscle training, or electrical stimulation, within the preceding six months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation

    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

  • Active comparator
    Standard urotherapy, Alarm therapy

    Participants will receive standard urotherapy and alarm therapy for 12 weeks.

    Behavioral: Standard urotherapy, Alarm therapy

Interventions

  • BehavioralStandard urotherapy, Alarm therapy

    Participants will receive standard urotherapy and alarm therapy for 12 weeks.

  • BehavioralStandard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation

    Participants will receive standard urotherapy, alarm therapy, and pelvic floor muscle rehabilitation for 12 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

07

Study locations

1 of 1 sites recruiting
  • Hacettepe University
    Ankara, Ankara 06680, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 27 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 22, 2026
StartActual
Aug 31, 2026
Primary completionEst.
Dec 20, 2028
CompletionEst.
Dec 20, 2028
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07890194
Responsible party
Canan Seyhan (MSc, Hacettepe University) — Principal investigator
First posted
Oct 22, 2026
Start date
Aug 31, 2026
Primary completion
Dec 20, 2028 (estimated)
Completion
Dec 20, 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Canan Seyhan, Ph.D. (c)
Contact
cananseyhan@gmail.com
+90 532 708 2646
Türkan AKBAYRAK, Prof. Dr.
Contact
takbayrak@hacettepe.edu.tr
+90 312 305 1576
Türkan AKBAYRAK, Prof. Dr.
study director · Hacettepe University
Canan Seyhan, Ph.D. (c)
principal investigator · Hacettepe University
Murat DAYANÇ, Prof. Dr.
study chair · Private Dayanc Pediatric Urology Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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