Monosymptomatic Enuresis NocturnaNCT00404638
Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
A study testing Desmopresin and Paula Method of Circular Muscle Exercise in people with Monosymptomatic Enuresis Nocturna, run by Rabin Medical Center at 2 sites in Israel.
Trial summary
Several treatment modalities for children suffering from monosymptomathic nocturnal enuresis are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback. The aim of this study is to to test if Paula Method (circular muscle exercise) can be an another treatment modality. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Monosymptomatic Enuresis Nocturna
- What is being tested?
- Desmopresin and Paula Method of Circular Muscle Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2006to not given
- Phase
- Interventional
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna
- informed consent
Who cannot join
- UTI
- neurological diseases or syndromes
- metabolic disesaes
- congenital disease or malformation of the urinary tract
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Campus Golda Hospital
Petah Tikva
Herman A Cohen, MD, 972-3-9398203, hermanc@clalit.org.il
Campus Rabin
Petah Tikva
About this study
Several treatment modalities for children suffering from monosymptomathic nocturnal enuresis are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback. The aim of this study is to to test if Paula Method (circular muscle exercise) can be an another treatment modality.
Read the detailed description
Paula method is based on circular muscle exercises. The theory behind the Paula method is that all sphincters in the human body work simultaneosly, mutually affecting one another possibly mediated by "oscillation" of the spinal cord. According to this theory, exercising the ring muscles in a certain area of the body will result in strengthening the circular muscles in other areas. This method was found to to be efficacious for treatment of urinary stress incontinence in women.
- Conditions
- Monosymptomatic Enuresis Nocturna
- Being tested
- Desmopresin, Paula Method of Circular Muscle Exercise
- Keywords
- Enuresis Nocturna, Paula Method, Circular muscle exercise, Sphincter
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopresinDrug
Paula Method of Circular Muscle ExerciseBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Monosymptomatic Enuresis NocturnaStudies 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
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Herman A Cohen, MD, Principal investigator, Schneider Children Hospital , Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404638
- Sponsor's protocol ID
- 004192
- Status last verified
- Nov 2006
- First submitted
- 28 Nov 2006
- Last updated
- 29 Nov 2006
- Results posted
- No
Publications
Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
PubMed 32364251
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Enuresis Nocturna by Circular Muscle Exercise (Paula Method)
- ClinicalTrials.gov ID
- NCT00404638
- Acronym / sponsor ID
- 004192
- Conditions
- Monosymptomatic Enuresis Nocturna
- Keywords
- Enuresis Nocturna, Paula Method, Circular muscle exercise, Sphincter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2006
- First posted
- 29 Nov 2006 (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.
Several treatment modalities for children suffering from monosymptomathic nocturnal enuresis are available including drugs, alarms, acupuncture, pelvic floor training and biofeedback. The aim of this study is to to test if Paula Method (circular muscle exercise) can be an another treatment modality.
Detailed description
Paula method is based on circular muscle exercises. The theory behind the Paula method is that all sphincters in the human body work simultaneosly, mutually affecting one another possibly mediated by "oscillation" of the spinal cord. According to this theory, exercising the ring muscles in a certain area of the body will result in strengthening the circular muscles in other areas. This method was found to to be efficacious for treatment of urinary stress incontinence in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age- 7 to 15 years old suffering from monosymptomatic enuresis nocturna
- informed consent
Key exclusion criteria (4 listed)
- UTI
- neurological diseases or syndromes
- metabolic disesaes
- congenital disease or malformation of the urinary tract
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 |
|---|---|---|
| Desmopresin | Drug | – |
| Paula Method of Circular Muscle Exercise | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2006.
- Derived from this study: PubMed 32364251Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
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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.
Herman A Cohen, MD principal investigator
Schneider Children Hospital , Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desmopresin and Paula Method of Circular Muscle Exercise in people with Monosymptomatic Enuresis Nocturna, run by Rabin Medical Center at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herman A Cohen, MD (972-3-9398203, hermanc@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00404638, which also lists 1 linked publication.
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 29 Nov 2006.