Daytime Urinary IncontinenceICCS，LUTD，PNENCT07000656
Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children
A study testing Micturition Desire-Relaxation Training Device in people with Daytime Urinary Incontinence and Urinary Frequency, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
Urine storage and voiding are fundamental physiological processes. In clinical settings, many cases of lower urinary tract dysfunction (LUTD) are closely associated with abnormal conditioned reflexes formed in the central nervous system during the urine storage or voiding phases. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Daytime Urinary Incontinence, Urinary Frequency, Lower Urinary Tract Dysfunction
- What is being tested?
- Micturition Desire-Relaxation Training Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 31 May 2026
- 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 according to the ICCS criteria:
- For nocturnal enuresis:
- At least one episode of involuntary nighttime urination per month for more than 3 months.
- No abnormalities in routine urinalysis. No period of bedwetting-free days lasting more than 6 months, except for organic diseases.
- For daytime urinary incontinence:
- At least one episode of intermittent urinary leakage during wakefulness per month for more than 3 months.
Show all 11Show fewer
- No anatomical or neurological causes of urinary incontinence.
- For urinary frequency:
- The child experiences only urinary frequency and urgency, occurring during the day and before sleep, with intervals ranging from a few minutes to 1 hour. Each urination involves a small volume, less than 50% of the estimated bladder capacity [EBC (mL) = 30 + (age × 30)], typically less than 30 mL, sometimes just a few drops, while total daily urine volume remains within normal limits. When the child is engaged in play or focused, the intervals between urination are extended, and urinary frequency symptoms disappear after falling asleep.
- Age: 5 to 18 years (inclusive), regardless of gender.
- Voluntary participation: The child and their guardian must voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Exclude enuresis caused by urinary tract infections, pinworms, myelitis, spinal cord injuries, epilepsy, cerebral developmental disorders, diabetes, and other neurological, urinary, or endocrine diseases, as well as transient enuresis due to excessive activity, mental fatigue, or excessive fluid intake before bedtime.
- Exclude conditions causing urinary frequency such as neurogenic bladder, urinary tract infections, urethral syndrome, hypercalciuria, or metabolic diseases.
- Patients who have participated in or are currently participating in other clinical trials within the past month.
- Patients deemed unsuitable for participation in the clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Micturition Desire-Relaxation Training
Shanghai, Shanghai Municipality, 200122
Jun Ma, 15880030598, majun@shsmu.edu.cn
About this study
Official title: Prospective Evaluation of Micturition Desire-Relaxation Training Device for Treating Lower Urinary Tract Dysfunction in Children: A Randomized Controlled Pilot Study
Urine storage and voiding are fundamental physiological processes. In clinical settings, many cases of lower urinary tract dysfunction (LUTD) are closely associated with abnormal conditioned reflexes formed in the central nervous system during the urine storage or voiding phases. Relaxation, as a core physiological and psychological state, has been shown to promote effective urine storage and facilitate smooth voiding. By repeatedly training individuals to establish a new conditioned reflex linking the sensation of urinary urgency with a state of relaxation, it may be possible to improve bladder storage capacity and voiding function. Based on this concept, the investigators have developed the world's first Micturition Desire-Relaxation Training Device (Chinese Patent No.: ZL 2020 1 0397789.4). This study aims to evaluate the clinical efficacy of this device in treating LUTD in children.
Read the detailed description
This randomized controlled trial aims to evaluate the clinical efficacy of the Micturition Desire-Relaxation Training Device in managing LUTD in children over a six-month period. A stratified block randomization method will be used, matching participants based on sex, age, and enuresis frequency. Eligible participants will be stratified by sex and age, and then randomly assigned (1:1) to either the intervention group or the sham intervention group using a computer-generated sequence. This method ensures group balance regarding baseline characteristics and enuresis severity.
In the intervention group, baseline voiding diaries will be completed prior to initiating training. The first session will be supervised by trained medical personnel, during which participants and caregivers will receive standardized instruction in device usage and bladder relaxation techniques. Each session will last approximately 10 minutes and will be conducted 3-4 times during the initial instructional phase. The device will then be provided for home use at no cost. Caregivers will receive remote support from study physicians during the intervention period. Home-based training will include 5-10 sessions per day, each lasting 10 minutes. Daily records-including images of urine output, session duration, and any adverse events-will be uploaded to a secure cloud platform for physician review. The intervention will continue for 8 weeks. Monthly records of fluid intake and voiding behavior will be maintained throughout the study. Follow-up assessments, including voiding diaries and enuresis questionnaires, will be performed at 3 and 6 months post-intervention to assess recurrence and long-term outcomes.
The sham group will follow identical baseline and training schedules; however, the device will remain inactive during each session. After 4 weeks, participants in this group will submit fluid intake and voiding records.
Primary outcome measures include the enuresis improvement rate, frequency of daytime urinary incontinence, and total number of voiding episodes within 24 hours. Secondary outcomes will include: scores for the micturition desire-awakening function, timing of enuresis events, bedtime and wake time, standardized bladder capacity, bladder variability rate, behavioral responses during incontinence, psychological/behavioral characteristics, and enuresis recurrence.
- Conditions
- Daytime Urinary Incontinence, Urinary Frequency, Lower Urinary Tract Dysfunction, Primary Nocturnal Enuresis
- Being tested
- Micturition Desire-Relaxation Training Device, Sham device
- Medical subject headings
- Diurnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micturition Desire-Relaxation Training DeviceDevice
The device was developed by Shanghai Children's Medical Center in collaboration with Shanghai University of Engineering Science. It plays relaxation videos through a VR device and monitors the subjects' brain waves in real time using electroencephalography to evaluate their relaxation levels. The relaxation material is adjusted accordingly, and urination is recorded after training. Urine is collected and analyzed with a flow meter, generating a diagnostic report.
Sham deviceDevice
Participants diagnosed with nocturnal enuresis, daytime urinary incontinence, and urinary frequency will be screened at Shanghai Children's Medical Center, and eligible patients will be recruited. Participants will be randomly assigned to the sham training group, in which they will wear the device without powering it on for 10 minutes each session, 5-10 times a day, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sham Intervention Group | Sham comparator | This arm will enroll pediatric participants diagnosed with PNE, daytime urinary incontinence, or urinary frequency disorder according to the ICCS diagnostic criteria. Participants will follow the same baseline assessment protocol and stratified randomization based on sex, age, and enuresis frequency. They will undergo sham Micturition Desire-Relaxation Training, during which the device will remain inactive throughout each session. Training sessions will last approximately 10 minutes and be performed 5 to 10 times daily for a total of 4 weeks. A fluid intake and voiding diary will be submitted at the end of the sham training period. Participants will continue with follow-up assessments at 3 and 6 months post-intervention to evaluate natural symptom progression and recurrence, without further training. Receives: Device: Sham device |
| Micturition Desire-Relaxation Training | Experimental | This study includes children diagnosed with PNE, daytime urinary incontinence, and urinary frequency disorder according to the ICCS diagnostic criteria. Participants in the intervention group will undergo Micturition Desire-Relaxation Training, with each session lasting approximately 10 minutes, performed 5 to 10 times per day over an 8-week period. Changes in clinical symptoms and any adverse events will be systematically documented at baseline, and at 1 and 2 months during the intervention, as well as at 3 and 6 months post-treatment. For participants who achieve complete remission, caregivers will be asked to maintain daily records of enuresis episodes at 3 and 6 months after treatment to monitor potential recurrence. Receives: Device: Micturition Desire-Relaxation Training Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enuresis improvement rate
The enuresis improvement rate is the sum of the complete and partial response rates. No response: <50% reduction. Partial response: 50 to 99% reduction. Complete response: 100% reduction.
Measured: From enrollment to the end of treatment at 6 months
Daytime urinary incontinence frequency
The frequency of daytime urinary incontinence will be recorded using a voiding diary, with caregivers documenting each episode of urine leakage during waking hours. The daily frequency will be categorized using a study-specific ordinal scoring system as follows:
Score 0: No daytime incontinence Score 1: ≤1 episode/day Score 2: 2-3 episodes/day Score 3: ≥4 episodes/day Higher scores indicate more severe daytime urinary incontinence.
Measured: From enrollment to the end of treatment at 6 months
Total number of voiding episodes in 24 hours
The total number of voiding episodes per 24 hours will be calculated using a 3-day bladder diary. This includes both daytime and nighttime voids.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (8)
Grade scoring of the micturition desire - awakening function
The micturition desire-awakening function will be assessed using a study-specific, investigator-defined scoring system based on average nocturnal awakening ability. Scores range from 1 to 5, with higher scores indicating poorer awakening response to bladder signals. The scoring criteria are as follows: Score 5: Remains asleep most of the time after urination.
Score 4: Only awakens after completely wetting the bed. Score 3: Awakens only after urinating a significant amount and then goes to the toilet to void the remaining urine.
Score 2: Awakens after urinating a small amount and then goes to the toilet to void the remaining urine.
Score 1: Awakened by the urge to urinate, without wetting the bed.
Measured: From enrollment to the end of treatment at 6 months
Enuresis recurrence rate
Recurrence is defined as the reappearance of enuresis in previously cured patients, occurring more than once per month.
Measured: From enrollment to the end of treatment at 6 months
Timing of nocturnal enuresis episodes
The timing of nocturnal enuresis episodes will be recorded during the night. If multiple episodes occur, the time of the first episode will be used for analysis.
Measured: From enrollment to the end of treatment at 6 months
Child's bedtime and wake time
The child's bedtime and wake-up time will be recorded daily throughout the intervention period.
Measured: From enrollment to the end of treatment at 6 months
Standardized bladder capacity
Standardized bladder capacity = bladder capacity/body surface area. Compare the standardized mean bladder capacity as well as the maximum and minimum daytime/nighttime bladder capacity changes from baseline to 6 months.
The term mean daytime bladder capacity refers to the average volume of voided urine measured on the frequency volume chart throughout a 24-hour cycle.
The term maximum/minimum daytime bladder capacity refers to the largest/smallest volume of voided urine measured on the frequency volume chart during the day. It excludes the first morning void.
The term maximum/minimum nighttime bladder capacity refers to the largest/smallest volume of voided urine measured on the frequency volume chart during the night. It includes the first morning void.
Measured: From enrollment to the end of treatment at 6 months
Bladder variability rate
Bladder variability rate = (standard deviation / average bladder capacity) * 100% The average bladder capacity and standard deviation will be calculated based on each voided volume from the 3-day bladder diary to determine the variability rate.
Measured: From enrollment to the end of treatment at 6 months
Behavioral response during daytime urinary incontinence episodes
Behaviors of the child during episodes of daytime incontinence will be recorded, such as whether the child is aware of the leakage, embarrassed, attempts to hide it, or seeks help.
Measured: From enrollment to the end of treatment at 6 months
Child's psychological and behavioral characteristics
The psychological and behavioral characteristics of the child will be assessed using the Strengths and Difficulties Questionnaire (SDQ). This standardized instrument evaluates five domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
The SDQ comprises 25 items, each rated on a 3-point scale (0 = "Not True," 1 = "Somewhat True," 2 = "Certainly True"). Subscale scores (range: 0-10) are calculated for each of the five domains. The Total Difficulties Score (range: 0-40) is derived by summing the scores of the first four subscales, excluding prosocial behavior. Higher total difficulties scores indicate more severe psychological problems, whereas higher prosocial scores reflect better social behavior.
Total and subscale scores will be used to track changes in psychological and behavioral functioning throughout the study.
Measured: Assessed every 3 months from enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start20 Nov 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Daytime Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000656
- Sponsor's protocol ID
- MR-31-24-03
- Acronym
- ICCS，LUTD，PNE
- Status last verified
- Jun 2025
- First submitted
- 24 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergmann M, Corigliano T, Ataia I, Renella R, Simonetti GD, Bianchetti MG, von Vigier RO. Childhood extraordinary daytime urinary frequency-a case series and a systematic literature review. Pediatr Nephrol. 2009 Apr;24(4):789-95. doi: 10.1007/s00467-008-1082-9. Epub 2008 Dec 18.
PubMed 19093136Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Vande Walle J, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society. J Urol. 2014 Jun;191(6):1863-1865.e13. doi: 10.1016/j.juro.2014.01.110. Epub 2014 Feb 4.
PubMed 24508614
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Micturition Desire-Relaxation Training Device for Treating Lower Urinary Tract Dysfunction in Children: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07000656
- Acronym / sponsor ID
- ICCS，LUTD，PNE / MR-31-24-03
- Conditions
- Daytime Urinary Incontinence, Urinary Frequency, Lower Urinary Tract Dysfunction, Primary Nocturnal Enuresis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Jun 2025 (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.
Urine storage and voiding are fundamental physiological processes. In clinical settings, many cases of lower urinary tract dysfunction (LUTD) are closely associated with abnormal conditioned reflexes formed in the central nervous system during the urine storage or voiding phases. Relaxation, as a core physiological and psychological state, has been shown to promote effective urine storage and facilitate smooth voiding. By repeatedly training individuals to establish a new conditioned reflex linking the sensation of urinary urgency with a state of relaxation, it may be possible to improve bladder storage capacity and voiding function. Based on this concept, the investigators have developed the world's first Micturition Desire-Relaxation Training Device (Chinese Patent No.: ZL 2020 1 0397789.4). This study aims to evaluate the clinical efficacy of this device in treating LUTD in children.
Detailed description
This randomized controlled trial aims to evaluate the clinical efficacy of the Micturition Desire-Relaxation Training Device in managing LUTD in children over a six-month period. A stratified block randomization method will be used, matching participants based on sex, age, and enuresis frequency. Eligible participants will be stratified by sex and age, and then randomly assigned (1:1) to either the intervention group or the sham intervention group using a computer-generated sequence. This method ensures group balance regarding baseline characteristics and enuresis severity.
In the intervention group, baseline voiding diaries will be completed prior to initiating training. The first session will be supervised by trained medical personnel, during which participants and caregivers will receive standardized instruction in device usage and bladder relaxation techniques. Each session will last approximately 10 minutes and will be conducted 3-4 times during the initial instructional phase. The device will then be provided for home use at no cost. Caregivers will receive remote support from study physicians during the intervention period. Home-based training will include 5-10 sessions per day, each lasting 10 minutes. Daily records-including images of urine output, session duration, and any adverse events-will be uploaded to a secure cloud platform for physician review. The intervention will continue for 8 weeks. Monthly records of fluid intake and voiding behavior will be maintained throughout the study. Follow-up assessments, including voiding diaries and enuresis questionnaires, will be performed at 3 and 6 months post-intervention to assess recurrence and long-term outcomes.
The sham group will follow identical baseline and training schedules; however, the device will remain inactive during each session. After 4 weeks, participants in this group will submit fluid intake and voiding records.
Primary outcome measures include the enuresis improvement rate, frequency of daytime urinary incontinence, and total number of voiding episodes within 24 hours. Secondary outcomes will include: scores for the micturition desire-awakening function, timing of enuresis events, bedtime and wake time, standardized bladder capacity, bladder variability rate, behavioral responses during incontinence, psychological/behavioral characteristics, and enuresis recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Intervention Group | Sham comparator | Device: Sham deviceThis arm will enroll pediatric participants diagnosed with PNE, daytime urinary incontinence, or urinary frequency disorder according to the ICCS diagnostic criteria. Participants will follow the same baseline assessment protocol and stratified randomization based on sex, age, and enuresis frequency. They will undergo sham Micturition Desire-Relaxation Training, during which the device will remain inactive throughout each session. Training sessions will last approximately 10 minutes and be performed 5 to 10 times daily for a total of 4 weeks. A fluid intake and voiding diary will be submitted at the end of the sham training period. Participants will continue with follow-up assessments at 3 and 6 months post-intervention to evaluate natural symptom progression and recurrence, without further training. |
| Micturition Desire-Relaxation Training | Experimental | Device: Micturition Desire-Relaxation Training DeviceThis study includes children diagnosed with PNE, daytime urinary incontinence, and urinary frequency disorder according to the ICCS diagnostic criteria. Participants in the intervention group will undergo Micturition Desire-Relaxation Training, with each session lasting approximately 10 minutes, performed 5 to 10 times per day over an 8-week period. Changes in clinical symptoms and any adverse events will be systematically documented at baseline, and at 1 and 2 months during the intervention, as well as at 3 and 6 months post-treatment. For participants who achieve complete remission, caregivers will be asked to maintain daily records of enuresis episodes at 3 and 6 months after treatment to monitor potential recurrence. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Diagnosis according to the ICCS criteria:
- At least one episode of involuntary nighttime urination per month for more than 3 months.
- No abnormalities in routine urinalysis. No period of bedwetting-free days lasting more than 6 months, except for organic diseases.
- At least one episode of intermittent urinary leakage during wakefulness per month for more than 3 months.
- No anatomical or neurological causes of urinary incontinence.
Key exclusion criteria (4 listed)
- Exclude enuresis caused by urinary tract infections, pinworms, myelitis, spinal cord injuries, epilepsy, cerebral developmental disorders, diabetes, and other neurological, urinary, or endocrine diseases, as well as transient enuresis due to excessive activity, mental fatigue, or excessive fluid intake before bedtime.
- Exclude conditions causing urinary frequency such as neurogenic bladder, urinary tract infections, urethral syndrome, hypercalciuria, or metabolic diseases.
- Patients who have participated in or are currently participating in other clinical trials within the past month.
- Patients deemed unsuitable for participation in the clinical trial by the investigator.
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 |
|---|---|---|
| Micturition Desire-Relaxation Training DeviceThe device was developed by Shanghai Children's Medical Center in collaboration with Shanghai University of Engineering Science. It plays relaxation videos through a VR device and monitors the subjects' brain waves in real time using electroencephalography to evaluate their relaxation levels. The relaxation material is adjusted accordingly, and urination is recorded after training. Urine is collected and analyzed with a flow meter, generating a diagnostic report. | Device | Micturition Desire-Relaxation Training |
| Sham deviceParticipants diagnosed with nocturnal enuresis, daytime urinary incontinence, and urinary frequency will be screened at Shanghai Children's Medical Center, and eligible patients will be recruited. Participants will be randomly assigned to the sham training group, in which they will wear the device without powering it on for 10 minutes each session, 5-10 times a day, for 4 weeks. | Device | Sham Intervention Group |
Primary outcome
Enuresis improvement rate
Time frame: From enrollment to the end of treatment at 6 months
The enuresis improvement rate is the sum of the complete and partial response rates. No response: <50% reduction. Partial response: 50 to 99% reduction. Complete response: 100% reduction.
Daytime urinary incontinence frequency
Time frame: From enrollment to the end of treatment at 6 months
The frequency of daytime urinary incontinence will be recorded using a voiding diary, with caregivers documenting each episode of urine leakage during waking hours. The daily frequency will be categorized using a study-specific ordinal scoring system as follows: Score 0: No daytime incontinence Score 1: ≤1 episode/day Score 2: 2-3 episodes/day Score 3: ≥4 episodes/day Higher scores indicate more severe daytime urinary incontinence.
Total number of voiding episodes in 24 hours
Time frame: From enrollment to the end of treatment at 6 months
The total number of voiding episodes per 24 hours will be calculated using a 3-day bladder diary. This includes both daytime and nighttime voids.
8 secondary outcomes
Grade scoring of the micturition desire - awakening function
Time frame: From enrollment to the end of treatment at 6 months
Enuresis recurrence rate
Time frame: From enrollment to the end of treatment at 6 months
Timing of nocturnal enuresis episodes
Time frame: From enrollment to the end of treatment at 6 months
Child's bedtime and wake time
Time frame: From enrollment to the end of treatment at 6 months
Standardized bladder capacity
Time frame: From enrollment to the end of treatment at 6 months
Bladder variability rate
Time frame: From enrollment to the end of treatment at 6 months
Behavioral response during daytime urinary incontinence episodes
Time frame: From enrollment to the end of treatment at 6 months
Child's psychological and behavioral characteristics
Time frame: Assessed every 3 months from enrollment to the end of treatment at 6 months
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 5 Jun 2025.
- Results publication: PubMed 19093136Bergmann M, Corigliano T, Ataia I, Renella R, Simonetti GD, Bianchetti MG, von Vigier RO. Childhood extraordinary daytime urinary frequency-a case series and a systematic literature review. Pediatr Nephrol. 2009 Apr;24(4):789-95. doi: 10.1007/s00467-008-1082-9. Epub 2008 Dec 18.
- Results publication: PubMed 24508614Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Vande Walle J, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society. J Urol. 2014 Jun;191(6):1863-1865.e13. doi: 10.1016/j.juro.2014.01.110. Epub 2014 Feb 4.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micturition Desire-Relaxation Training Device in people with Daytime Urinary Incontinence and Urinary Frequency, run by Shanghai Children's Medical Center at 1 site in China.
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 11 inclusion and 4 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 5 Jun 2025. 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 China. 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. Some participants in this study may receive a placebo. 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 jun ma (13917230745, majun@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enuresis improvement rate (time frame: From enrollment to the end of treatment at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000656, which also lists 2 linked publications.
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 5 Jun 2025.