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).
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
- Conditions the study is for
- Primary Monosymptomatic Nocturnal Enuresis
- What is being tested?
- Standard urotherapy, Alarm therapy and Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- 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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Ankara, 06680
Canan Seyhan, MSc, 905327082646, cananseyhan@gmail.com
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 group | Role | What they receive |
|---|---|---|
| Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation | Experimental | Participants 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 therapy | Active comparator | Participants 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.
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.
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)
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.
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.
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.
- First posted22 Oct 2026
- Study start31 Aug 2026
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Monosymptomatic Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Seyhan, Hacettepe University
- Investigators
- Türkan AKBAYRAK, Prof. Dr., Study director, Hacettepe UniversityCanan Seyhan, Ph.D. (c), Principal investigator, Hacettepe UniversityMurat DAYANÇ, Prof. Dr., Study chair, Private Dayanc Pediatric Urology Center
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Individualized Pelvic Floor Muscle Rehabilitation in Addition to Standard Urotherapy and Alarm Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis
- ClinicalTrials.gov ID
- NCT07890194
- Acronym / sponsor ID
- FTREK26/127
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation | Experimental | Behavioral: Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitationParticipants will receive standard urotherapy, alarm therapy, and pelvic floor muscle rehabilitation for 12 weeks. |
| Standard urotherapy, Alarm therapy | Active comparator | Behavioral: Standard urotherapy, Alarm therapyParticipants will receive standard urotherapy and alarm therapy for 12 weeks. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard urotherapy, Alarm therapyParticipants will receive standard urotherapy and alarm therapy for 12 weeks. | Behavioural | Standard urotherapy, Alarm therapy |
| Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitationParticipants will receive standard urotherapy, alarm therapy, and pelvic floor muscle rehabilitation for 12 weeks. | Behavioural | Standard urotherapy, Alarm therapy, Individualized pelvic floor muscle rehabilitation |
Primary outcome
Number of Dry Nights
Time frame: Baseline and weeks 4, 8, and 12.
The number of nights without involuntary urine leakage during sleep will be recorded by parents using an enuresis diary.
Number of Enuresis Alarm Activations
Time frame: Baseline and weeks 4, 8, and 12.
The number of moisture-triggered enuresis alarm activations during sleep will be recorded by parents using an enuresis diary.
3 secondary outcomes
Treatment Response According to ICCS Criteria
Time frame: Baseline and weeks 12.
Dysfunctional Voiding and Incontinence Scoring System (DVISS) Score
Time frame: Baseline and weeks 4, 8, and 12.
Nocturnal Enuresis Symptom Score (NESS)
Time frame: Baseline and weeks 4, 8, and 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Monosymptomatic Nocturnal Enuresis
Recruiting
Bedtime Device Restriction and Desmopressin in PMNE.
Primary Monosymptomatic Nocturnal Enuresis
Not yet recruitingObservational study
Causes and Types of Nocturnal Enuresis in Children
Nocturnal Enuresis, Nocturnal Enuresis in Children
Not yet recruitingObservational study
Serum Copeptin as Biomarker for Diagnosis and Classification of Polyuric Primary Monosymptomatic Nocturnal Enuresis
Primary Monosymptomatic Nocturnal Enuresis, Copeptin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
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.