Neurogenic IncontinenceNICNOCNCT01465581
Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale
An observational study of Neurogenic Incontinence and Dysfunctional Voiding, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Neurogenic Incontinence, Dysfunctional Voiding
- What is being tested?
- Division of the filum terminal
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2014
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy. These children will have abnormal urodynamics, a normal bladder ultrasound and an MR imaging showing that the conus medullaris of the spinal cord is at a normal position and that there is no other significant dysraphic lesion present. The entry criteria are designed to separate this very specific subset of patients from the much larger, more general group of children presenting for evaluation and management of incontinence.
Who may be able to join
- Primary or secondary daytime urinary incontinence, persistent over at least 6 months of medical treatment.
- Abnormal urodynamic testing
- Normal conus on magnetic resonance imaging of the spine
- Dysfunctional Voiding Symptom Scale score greater than 6 for girls or greater than 9 for boys
Who cannot join
- Bladder outlet obstruction
- Bladder atony
- Congenital anorectal malformation
- Additional diagnoses independently associated with neurogenic bladder dysfunction
- Encephalopathy precluding reasonable expectation of attainment of continence
- Inability to comply with medical management
- Unwillingness to comply with initial or follow up urodynamic testing
Trial locations and contacts
1 site in 1 country.
United States1 site
A I duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus
The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy.
The study hypothesis is that patients who under go cutting the filum terminale - the string-like lower end of the spinal cord - will have improved bladder function at 6-month follow up.
Bladder function and its effects on quality of life will be measured before surgery and at 6-month follow up.
- Conditions
- Neurogenic Incontinence, Dysfunctional Voiding
- Being tested
- Division of the filum terminal
- Keywords
- incontinence, dysfunctional voiding, neurogenic bladder disturbance, filum terminale, spinal cord tethering, conus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Division of the filum terminalProcedure or surgery
Division of the filum is performed through a 6cm incision over the lumbosacral junction that can be oriented either longitudinally or transversely - to be hidden beneath underclothes or swim wear. A single level laminectomy provides sufficient exposure. The dural opening can be as short as 1cm. Under the microscope the filum is identified visually and separated from lower sacral rootlets with the aid of microelectrode stimulation. When a segment of the filum has been excised and sent for laboratory examination, the dura is closed and reinforced with fibrin glue. The wound is closed in layers, and the patient is kept at bed rest horizontal for 2 nights to discourage CSF fistulization of the wound.
| Study group | Role | What they receive |
|---|---|---|
| Neurogenic incontinence | The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy. These children will have abnormal urodynamics, a normal bladder ultrasound and an MR imaging showing that the conus of the spinal cord is at a normal position and that there is no other significant dysraphic lesion present. Receives: Procedure: Division of the filum terminal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life
Measured: 6-month follow up
Secondary outcomes (3)
Change from baseline in a 24-hour voiding log
Measured: 6-month follow up
Change from baseline in the Dysfunctional Voiding Symptom Scale
Measured: 6-month follow up
Change from baseline urodynamic testing
Measured: 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Insufficient patient accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph H Piatt, MD, Principal investigator, Alfred I. duPont Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465581
- Sponsor's protocol ID
- 228683
- Acronym
- NICNOC
- Status last verified
- Nov 2011
- First submitted
- 26 Oct 2011
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus
- ClinicalTrials.gov ID
- NCT01465581
- Acronym / sponsor ID
- NICNOC / 228683
- Conditions
- Neurogenic Incontinence, Dysfunctional Voiding
- Keywords
- incontinence, dysfunctional voiding, neurogenic bladder disturbance, filum terminale, spinal cord tethering, conus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient patient accrual.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Nov 2011 (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.
The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy.
The study hypothesis is that patients who under go cutting the filum terminale - the string-like lower end of the spinal cord - will have improved bladder function at 6-month follow up.
Bladder function and its effects on quality of life will be measured before surgery and at 6-month follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurogenic incontinence | – | Procedure: Division of the filum terminalThe target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy. These children will have abnormal urodynamics, a normal bladder ultrasound and an MR imaging showing that the conus of the spinal cord is at a normal position and that there is no other significant dysraphic lesion present. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy. These children will have abnormal urodynamics, a normal bladder ultrasound and an MR imaging showing that the conus medullaris of the spinal cord is at a normal position and that there is no other significant dysraphic lesion present. The entry criteria are designed to separate this very specific subset of patients from the much larger, more general group of children presenting for evaluation and management of incontinence.
Key inclusion criteria (4 listed)
- Primary or secondary daytime urinary incontinence, persistent over at least 6 months of medical treatment.
- Abnormal urodynamic testing
- Normal conus on magnetic resonance imaging of the spine
- Dysfunctional Voiding Symptom Scale score greater than 6 for girls or greater than 9 for boys
Key exclusion criteria (7 listed)
- Bladder outlet obstruction
- Bladder atony
- Congenital anorectal malformation
- Additional diagnoses independently associated with neurogenic bladder dysfunction
- Encephalopathy precluding reasonable expectation of attainment of continence
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 |
|---|---|---|
| Division of the filum terminalDivision of the filum is performed through a 6cm incision over the lumbosacral junction that can be oriented either longitudinally or transversely - to be hidden beneath underclothes or swim wear. A single level laminectomy provides sufficient exposure. The dural opening can be as short as 1cm. Under the microscope the filum is identified visually and separated from lower sacral rootlets with the aid of microelectrode stimulation. When a segment of the filum has been excised and sent for laboratory examination, the dura is closed and reinforced with fibrin glue. The wound is closed in layers, and the patient is kept at bed rest horizontal for 2 nights to discourage CSF fistulization of the wound. | Procedure or surgery | Neurogenic incontinence |
Primary outcome
Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life
Time frame: 6-month follow up
3 secondary outcomes
Change from baseline in a 24-hour voiding log
Time frame: 6-month follow up
Change from baseline in the Dysfunctional Voiding Symptom Scale
Time frame: 6-month follow up
Change from baseline urodynamic testing
Time frame: 6-month follow up
Results and safety
The study was stopped early (reason given: Insufficient patient accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
Related trials for Neurogenic Incontinence
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EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
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Spina Bifida, Neurogenic Bowel
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.
Joseph H Piatt, MD principal investigator
Alfred I. duPont Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Incontinence and Dysfunctional Voiding, run by Nemours Children's Clinic at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 17 Apr 2015. 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 United States. 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?
The study was stopped early (reason given: Insufficient patient accrual.). Results are not available in the source record.
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?
Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life (time frame: 6-month follow up). 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 17 Apr 2015.