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Primary Monosymptomatic Nocturnal EnuresisNCT07890194

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

A study testing Standard urotherapy, Alarm therapy and Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation in people with Primary Monosymptomatic Nocturnal Enuresis, run by Hacettepe University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
What is being tested?
Standard urotherapy, Alarm therapy and Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
31 Aug 2026to 20 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canan Seyhan, Ph.D. (c) contact

+90 532 708 2646

cananseyhan@gmail.com

Türkan AKBAYRAK, Prof. Dr. contact

+90 312 305 1576

takbayrak@hacettepe.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Hacettepe University

    Ankara, Ankara, 06680

    Canan Seyhan, MSc, 905327082646, cananseyhan@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
Standard urotherapy, Alarm therapy, Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard urotherapy, Alarm therapyBehavioural

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

  • Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitationBehavioural

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

Study groups in NCT07890194
Study groupRoleWhat they receive
Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitationExperimentalParticipants will receive standard urotherapy, alarm therapy, and pelvic floor muscle rehabilitation for 12 weeks.
Receives: Behavioral: Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation
Standard urotherapy, Alarm therapyActive comparatorParticipants will receive standard urotherapy and alarm therapy for 12 weeks.
Receives: Behavioral: Standard urotherapy, Alarm therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Dry Nights

    The number of nights without involuntary urine leakage during sleep will be recorded by parents using an enuresis diary.

    Measured: 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.

    Measured: Baseline and weeks 4, 8, and 12.

Secondary outcomes (3)
  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).

    Measured: 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.

    Measured: 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

    Measured: Baseline and weeks 4, 8, and 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start31 Aug 2026
  3. Primary completion20 Dec 2028 (estimated)
  4. Study completion20 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07890194
Sponsor's protocol ID
FTREK26/127
Status last verified
Sep 2026
First submitted
16 Oct 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard urotherapy, Alarm therapy and Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation in people with Primary Monosymptomatic Nocturnal Enuresis, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Canan Seyhan, Ph.D. (c) (+90 532 708 2646, cananseyhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Dry Nights (time frame: Baseline and weeks 4, 8, and 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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