Diurnal EnuresisPhase 4NCT02336906
Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction
A Phase 4 study testing polyethylene glycol 3350, Constipation behavioral therapy and Urotherapy in people with Diurnal Enuresis, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Constipation treatment has been found to ameliorate symptoms in some patients with lower urinary tract dysfunction (including day time or combined day time/night time urinary incontinence). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Diurnal Enuresis
- What is being tested?
- polyethylene glycol 3350, Constipation behavioral therapy and Urotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2020to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5-17 years at time of signing of informed consent.
- Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of >11 on the Vancouver Questionnaire .
- Do not meet Rome III criteria for functional constipation.
Who cannot join
- Inability to provide signed informed consent.
- Inability to comply with the study protocol.
- Neurogenic bladder
- Attention Deficit Disorder (ADD or ADHD) on medical treatment.
- Known significant sacral, perineal, or other congenital or surgical defect.
- Known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis)
- Patient taking medicinal drugs which can cause urinary incontinence or constipation.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Institute of Gastroenterology, Nutrition, and Liver Diseases; Schneider Children's Medical Center of Israel
Petah Tikva, 49202
About this study
Official title: A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Lower Urinary Tract Dysfunction (LUTD) Not Meeting ROME-III Constipation Criteria
Constipation treatment has been found to ameliorate symptoms in some patients with lower urinary tract dysfunction (including day time or combined day time/night time urinary incontinence). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to anti-constipation treatment with reduction of their urinary tract symptoms. Assessment of severity and response of lower urinary tract dysfunction will be based on the Vancouver NULTD/DES questionnaire.
- Conditions
- Diurnal Enuresis
- Being tested
- polyethylene glycol 3350, Constipation behavioral therapy, Urotherapy
- Keywords
- Lower urinary tract dysfunction, constipation
- Medical subject headings
- Diurnal Enuresis, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol 3350Drug
Also called PEG3350, Normalax
Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and the stepped down to 0.8gr/kg subsequently tapered according to stool consistency and frequency.
Constipation behavioral therapyBehavioural
Patients in the active group will receive dietary instruction as to fiber content, as well as behavior therapy including active sitting on the toilet to attempt defacation following meals.
UrotherapyBehavioural
The children will be guided for appropriate drinking and toilet habits, and will start with timed voiding.
| Study group | Role | What they receive |
|---|---|---|
| Urotherapy + Constipation Treatment | Active comparator | This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction. Receives: Drug: polyethylene glycol 3350; Behavioral: Constipation behavioral therapy; Behavioral: Urotherapy |
| Urotherapy alone | Other | This group will receive standard behavioral urotherapy alone. Receives: Behavioral: Urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.
Measured: 14 weeks
Secondary outcomes (3)
Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response in patient subgroups with fecal loading compared to those without fecal loading.
Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response to therapy in those with radiological evidence of fecal loading on enrollment abdominal x-ray (as defined by rectal/pelvic outlet ratio, Leech score, and Barr score) compared to those who did not in the intervention group and the urotherapy group
Measured: 14 weeks
Sustained Response - Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response 12 weeks after intervention has ended.
Measured: 26 weeks
Number of participants with adverse effects
Adverse effects of interventions as reported by patients/care givers during visits
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Changes in departmental staff have led to a cut in research alotments.
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 Diurnal EnuresisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noam Zevit, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336906
- Sponsor's protocol ID
- rmc130348ctil
- Status last verified
- Apr 2018
- First submitted
- 1 Jan 2015
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Afshar K, Mirbagheri A, Scott H, MacNeily AE. Development of a symptom score for dysfunctional elimination syndrome. J Urol. 2009 Oct;182(4 Suppl):1939-43. doi: 10.1016/j.juro.2009.03.009. Epub 2009 Aug 20.
PubMed 19695637Hodges SJ, Anthony EY. Occult megarectum--a commonly unrecognized cause of enuresis. Urology. 2012 Feb;79(2):421-4. doi: 10.1016/j.urology.2011.10.015. Epub 2011 Dec 14.
PubMed 22173180
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Lower Urinary Tract Dysfunction (LUTD) Not Meeting ROME-III Constipation Criteria
- ClinicalTrials.gov ID
- NCT02336906
- Acronym / sponsor ID
- rmc130348ctil
- Conditions
- Diurnal Enuresis
- Keywords
- Lower urinary tract dysfunction, constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in departmental staff have led to a cut in research alotments.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Jan 2015 (estimated)
- 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.
Constipation treatment has been found to ameliorate symptoms in some patients with lower urinary tract dysfunction (including day time or combined day time/night time urinary incontinence). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to anti-constipation treatment with reduction of their urinary tract symptoms. Assessment of severity and response of lower urinary tract dysfunction will be based on the Vancouver NULTD/DES questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urotherapy + Constipation Treatment | Active comparator | Drug: polyethylene glycol 3350, Behavioral: Constipation behavioral therapy, Behavioral: UrotherapyThis group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction. |
| Urotherapy alone | Other | Behavioral: UrotherapyThis group will receive standard behavioral urotherapy alone. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 5-17 years at time of signing of informed consent.
- Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of >11 on the Vancouver Questionnaire .
- Do not meet Rome III criteria for functional constipation.
Key exclusion criteria (7 listed)
- Inability to provide signed informed consent.
- Inability to comply with the study protocol.
- Neurogenic bladder
- Attention Deficit Disorder (ADD or ADHD) on medical treatment.
- Known significant sacral, perineal, or other congenital or surgical defect.
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 |
|---|---|---|
| polyethylene glycol 3350Also: PEG3350, NormalaxPatients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and the stepped down to 0.8gr/kg subsequently tapered according to stool consistency and frequency. | Drug | Urotherapy + Constipation Treatment |
| Constipation behavioral therapyPatients in the active group will receive dietary instruction as to fiber content, as well as behavior therapy including active sitting on the toilet to attempt defacation following meals. | Behavioural | Urotherapy + Constipation Treatment |
| UrotherapyThe children will be guided for appropriate drinking and toilet habits, and will start with timed voiding. | Behavioural | Urotherapy + Constipation Treatment, Urotherapy alone |
Primary outcome
Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.
Time frame: 14 weeks
3 secondary outcomes
Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response in patient subgroups with fecal loading compared to those without fecal loading.
Time frame: 14 weeks
Sustained Response - Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response 12 weeks after intervention has ended.
Time frame: 26 weeks
Number of participants with adverse effects
Time frame: 14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Background: PubMed 19695637Afshar K, Mirbagheri A, Scott H, MacNeily AE. Development of a symptom score for dysfunctional elimination syndrome. J Urol. 2009 Oct;182(4 Suppl):1939-43. doi: 10.1016/j.juro.2009.03.009. Epub 2009 Aug 20.
- Background: PubMed 22173180Hodges SJ, Anthony EY. Occult megarectum--a commonly unrecognized cause of enuresis. Urology. 2012 Feb;79(2):421-4. doi: 10.1016/j.urology.2011.10.015. Epub 2011 Dec 14.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing polyethylene glycol 3350, Constipation behavioral therapy and Urotherapy in people with Diurnal Enuresis, run by Rabin Medical Center at 1 site in Israel.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 11 Apr 2018. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention. (time frame: 14 weeks). 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 NCT02336906, 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 11 Apr 2018.