Fecal Incontinence with Fecal UrgencyLiNPHNCT04808076
Idiopathic Normal Pressure Hydrocephalus: Focus on Imaging and Clinical Symptoms.
A study testing Shunt surgery in people with Fecal Incontinence with Fecal Urgency and Urine Incontinence, run by Linkoeping University at 1 site in Sweden.
Trial summary
LiNPH is a prospective single center clinical and radiological study. Read more about this study
- Who is it for?
- Ages 61 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence with Fecal Urgency, Urine Incontinence, Diffusion Tensor Imaging
- What is being tested?
- Shunt surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSweden
- Study dates
- 12 Sep 2020to 30 Jun 2022
- 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 61 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Patients fulfilling the clinical and radiological criteria for a possible or probable iNPH diagnosis, according to the American-European Guidelines from 2005.
-
Exclusion Criteria: Patients unable to understand instructions with an MMSE lower than 17, claustrophobia or implant which makes the participation in MRI studies unable.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced MR-methods, Protein Levels in Cerebrospinal Fluid, Gait Analysis and Symptoms in Patients with Idiopathic Normal Pressure Hydrocephalus.
LiNPH is a prospective single center clinical and radiological study.
Read the detailed description
Fifty consecutive patients with idiopathic Normal Pressure Hydrocephalus (iNPH) diagnosed according to the American-European iNPH guidelines from 2005, are going to be recruited from the outpatient clinic at the Department of Neurology, University Hospital, Linköping, Sweden. All patients are going to undergo a primary evaluation and examination by a neurologist followed by a CT or/and a MRI of the brain. On MRI there should be symmetrical communicating ventricular enlargement without cortical infarcts or other lesions of clinical importance, except lacunar infarcts (<1 cm3), the Evans ratio should be ≥ 0.3 and the corpus callosum angle should be between 50o to 90o. The temporal horns and third ventricle should be relatively enlarged. Mild to moderate cortical atrophy and subcortical white matter hyper-intensity will be allowed. The motor function will be assessed by a physiotherapist using the following tests: time needed for a 10-meter (m) walk in steps (w10ms) and 10-m walk in time (w10mt) at a self-selected speed and with their usual walking aid, timed up and go test in seconds (TUGt) and steps (TUGs), which is a timed test for standing up from chair, walking 3 m, turning and walking back to the chair and sitting down. An occupational therapist will perform cognitive testing with Mini Mental State Examination (MMSE). A CSF-tap-test will be performed at the Neurology outpatient department, at around 10:00 pm, in all patients. For the CSF-TT the patients will lie in a recumbent position, and under sterile conditions by using a 10 ml subcutaneous Xylocaine dose as pain prevention, the investigators will applicate a spinal needle 18Gx3.50"x1.2mmx90mm. Once CSF is obtained, a spinal fluid manometer (Optidynamic, Mediplast, Italy) will be connected to measure the CSF pressure in cm H2O. The lumbar pressure will be measured during a period of almost one minute for avoiding artificially elevated levels. All patients will be relaxed and have their neck to a neutral position and their legs extended. Lumbar pressure will be measured before the CSF-TT. The CSF will be analyzed for: cells, lactate, albumin, isoelectric focusing, antibodies against Borrelia Burgdofferi, NFL, t-tau, p-tau, β-amyloid 42/40, β-amyloid and GFAP. After a multidisciplinary round the investigators will decide who is suitable for a ventriculoperitoneal shunt. All probable/possible iNPH patients, included in the study, will undergo a preoperative Tracted-Based Spatial Statistics (TBSS) and Diffusion Tensor Imaging (DTI) investigation one to two days before the operation. All included in this study patients will undergo the same work-up almost 3 months after the shunt surgery inclusive the TBSS and DTI. All patients will meet a neurosurgeon once after the operation for possible shunt valve adjustment.
In addition, 50 volunteer healthy control subjects (HI) over the age of 60 will be recruited. All HI will undergo examination by a neurologist, DTI,TBSS and answer questionnaires included in the study. The controls are recruited from relatives, University Hospital employees and friends of the research group through advertising and personal inquiries. Exclusion criteria are observable gait disorder, diagnosed dementia, obvious gait / balance disorder for other reasons, occurrence of claustrophobia, implants that make MRI examination impossible and neurological disorder that is detected in connection with MRI examination and urinary catheter and / or uro- / intestinal stomia.
Another part of this project is a qualitative questionnaire based single center prospective study. All LiNPH patients and HI are going to answer three questionnaires ( ICIQ-UI, Bowel function Questionnaire, Wexners FI) regarding gastrointestinal and urinary symptoms and the investigators are going to correlate them with clinical data before and after the shunt surgery. The aim of this study is to identify if fecal incontinence is a new unknown symptom in iNPH patients. The secondary aim of this study is to correlate DTI and TBSS data with urinary- and fecal-incontinence symptoms.
The primary aim of this study is to distinguish between reversible and irreversible changes in iNPH. To establish a new technique in investigation of patients with iNPH and early identify this group. A significant correlation between DTI results in one or more brain areas with the iNPH-results will give the investigators the opportunity to use a specific DTI protocol to easier identify iNPH-patients who will have positive results with a shunt operation. The investigators also aim to compare manual-DTI MRI and TBSS-based MRI results before and after shunt surgery.
- Conditions
- Fecal Incontinence with Fecal Urgency, Urine Incontinence, Diffusion Tensor Imaging, Leukoencephalopathies
- Being tested
- Shunt surgery
- Keywords
- Tract-Based Spatial Statistics, DTI, fecal incontinence, urine incontinence, whiter matter changes
- Medical subject headings
- Nocturnal Enuresis, Leukoencephalopathies, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shunt surgeryProcedure or surgery
Shunt operation
| Study group | Role | What they receive |
|---|---|---|
| iNPH patients | Active comparator | Shunt operation Receives: Procedure: Shunt surgery |
| Healthy Individuals | No intervention | Healthy individuals without any neurological disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Matter Changes in Idiopathic Normal Pressure Hydrocephalus: A Diffusion Tensor Imaging Study.
Franctional Anisotropi and Apparent Diffusion Coefficient changes before and 3 months after the shunt surgery and correlation with clinical data. All data will be compared with results from the Healthy individual group.
Measured: 2 years
Secondary outcomes (1)
Gastrointestinal and urinary symptoms in idiopathic Normal Pressure Hydrocephalus.
By using questionnaires possible gastrointestinal and urinary symptoms are going to be characterized, check existence and correlate with Diffusion Tensor Imaging data. Statistically control of differences with the Healthy Individual group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start12 Sep 2020
- Primary completion30 Jan 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fecal Incontinence with Fecal UrgencyStudies of the same condition, open and under way.
- More trials run by Linkoeping 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- INPH patients and Healthy Individuals.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fredrik Lundin, Linkoeping University
- Investigators
- Fredrik Lundin, MD, PhD, Study director, Department of Neurology and Department of Biomedical and Clinical Sciences, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808076
- Sponsor's protocol ID
- LinkoepingU2
- Acronym
- LiNPH
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2021
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eleftheriou A, Blystad I, Tisell A, Gasslander J, Lundin F. Publisher Correction: Indication of Thalamo-Cortical Circuit Dysfunction in Idiopathic Normal Pressure Hydrocephalus: A Diffusion Tensor Imaging Study. Sci Rep. 2020 Jul 16;10(1):12014. doi: 10.1038/s41598-020-69149-x.
PubMed 32678296Keong NC, Pena A, Price SJ, Czosnyka M, Czosnyka Z, DeVito EE, Housden CR, Sahakian BJ, Pickard JD. Diffusion tensor imaging profiles reveal specific neural tract distortion in normal pressure hydrocephalus. PLoS One. 2017 Aug 17;12(8):e0181624. doi: 10.1371/journal.pone.0181624. eCollection 2017.
PubMed 28817574Siasios I, Kapsalaki EZ, Fountas KN, Fotiadou A, Dorsch A, Vakharia K, Pollina J, Dimopoulos V. The role of diffusion tensor imaging and fractional anisotropy in the evaluation of patients with idiopathic normal pressure hydrocephalus: a literature review. Neurosurg Focus. 2016 Sep;41(3):E12. doi: 10.3171/2016.6.FOCUS16192.
PubMed 27581308Nakanishi A, Fukunaga I, Hori M, Masutani Y, Takaaki H, Miyajima M, Aoki S. Microstructural changes of the corticospinal tract in idiopathic normal pressure hydrocephalus: a comparison of diffusion tensor and diffusional kurtosis imaging. Neuroradiology. 2013 Aug;55(8):971-976. doi: 10.1007/s00234-013-1201-6. Epub 2013 Jun 2.
PubMed 23728069Ege S. [Management of urinary incontinence in a geriatric rehabilitation department : Global urinary incontinence assessment incorporating the International Consultation on Incontinence Questionnare - Urinary Incontinence Short Form (ICIQ-UI SF)]. Z Gerontol Geriatr. 2018 Apr;51(3):301-313. doi: 10.1007/s00391-016-1173-3. Epub 2017 Feb 8. German.
PubMed 28180932Marmarou A, Black P, Bergsneider M, Klinge P, Relkin N; International NPH Consultant Group. Guidelines for management of idiopathic normal pressure hydrocephalus: progress to date. Acta Neurochir Suppl. 2005;95:237-40. doi: 10.1007/3-211-32318-x_48.
PubMed 16463856Ishikawa M, Hashimoto M, Kuwana N, Mori E, Miyake H, Wachi A, Takeuchi T, Kazui H, Koyama H. Guidelines for management of idiopathic normal pressure hydrocephalus. Neurol Med Chir (Tokyo). 2008;48 Suppl:S1-23. doi: 10.2176/nmc.48.s1.
PubMed 18408356
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MR-methods, Protein Levels in Cerebrospinal Fluid, Gait Analysis and Symptoms in Patients with Idiopathic Normal Pressure Hydrocephalus.
- ClinicalTrials.gov ID
- NCT04808076
- Acronym / sponsor ID
- LiNPH / LinkoepingU2
- Conditions
- Fecal Incontinence with Fecal Urgency, Urine Incontinence, Diffusion Tensor Imaging, Leukoencephalopathies
- Keywords
- Tract-Based Spatial Statistics, DTI, fecal incontinence, urine incontinence, whiter matter changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Mar 2021 (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.
LiNPH is a prospective single center clinical and radiological study.
Detailed description
Fifty consecutive patients with idiopathic Normal Pressure Hydrocephalus (iNPH) diagnosed according to the American-European iNPH guidelines from 2005, are going to be recruited from the outpatient clinic at the Department of Neurology, University Hospital, Linköping, Sweden. All patients are going to undergo a primary evaluation and examination by a neurologist followed by a CT or/and a MRI of the brain. On MRI there should be symmetrical communicating ventricular enlargement without cortical infarcts or other lesions of clinical importance, except lacunar infarcts (<1 cm3), the Evans ratio should be ≥ 0.3 and the corpus callosum angle should be between 50o to 90o. The temporal horns and third ventricle should be relatively enlarged. Mild to moderate cortical atrophy and subcortical white matter hyper-intensity will be allowed. The motor function will be assessed by a physiotherapist using the following tests: time needed for a 10-meter (m) walk in steps (w10ms) and 10-m walk in time (w10mt) at a self-selected speed and with their usual walking aid, timed up and go test in seconds (TUGt) and steps (TUGs), which is a timed test for standing up from chair, walking 3 m, turning and walking back to the chair and sitting down. An occupational therapist will perform cognitive testing with Mini Mental State Examination (MMSE). A CSF-tap-test will be performed at the Neurology outpatient department, at around 10:00 pm, in all patients. For the CSF-TT the patients will lie in a recumbent position, and under sterile conditions by using a 10 ml subcutaneous Xylocaine dose as pain prevention, the investigators will applicate a spinal needle 18Gx3.50"x1.2mmx90mm. Once CSF is obtained, a spinal fluid manometer (Optidynamic, Mediplast, Italy) will be connected to measure the CSF pressure in cm H2O. The lumbar pressure will be measured during a period of almost one minute for avoiding artificially elevated levels. All patients will be relaxed and have their neck to a neutral position and their legs extended. Lumbar pressure will be measured before the CSF-TT. The CSF will be analyzed for: cells, lactate, albumin, isoelectric focusing, antibodies against Borrelia Burgdofferi, NFL, t-tau, p-tau, β-amyloid 42/40, β-amyloid and GFAP. After a multidisciplinary round the investigators will decide who is suitable for a ventriculoperitoneal shunt. All probable/possible iNPH patients, included in the study, will undergo a preoperative Tracted-Based Spatial Statistics (TBSS) and Diffusion Tensor Imaging (DTI) investigation one to two days before the operation. All included in this study patients will undergo the same work-up almost 3 months after the shunt surgery inclusive the TBSS and DTI. All patients will meet a neurosurgeon once after the operation for possible shunt valve adjustment.
In addition, 50 volunteer healthy control subjects (HI) over the age of 60 will be recruited. All HI will undergo examination by a neurologist, DTI,TBSS and answer questionnaires included in the study. The controls are recruited from relatives, University Hospital employees and friends of the research group through advertising and personal inquiries. Exclusion criteria are observable gait disorder, diagnosed dementia, obvious gait / balance disorder for other reasons, occurrence of claustrophobia, implants that make MRI examination impossible and neurological disorder that is detected in connection with MRI examination and urinary catheter and / or uro- / intestinal stomia.
Another part of this project is a qualitative questionnaire based single center prospective study. All LiNPH patients and HI are going to answer three questionnaires ( ICIQ-UI, Bowel function Questionnaire, Wexners FI) regarding gastrointestinal and urinary symptoms and the investigators are going to correlate them with clinical data before and after the shunt surgery. The aim of this study is to identify if fecal incontinence is a new unknown symptom in iNPH patients. The secondary aim of this study is to correlate DTI and TBSS data with urinary- and fecal-incontinence symptoms.
The primary aim of this study is to distinguish between reversible and irreversible changes in iNPH. To establish a new technique in investigation of patients with iNPH and early identify this group. A significant correlation between DTI results in one or more brain areas with the iNPH-results will give the investigators the opportunity to use a specific DTI protocol to easier identify iNPH-patients who will have positive results with a shunt operation. The investigators also aim to compare manual-DTI MRI and TBSS-based MRI results before and after shunt surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- INPH patients and Healthy Individuals.
| Arm | Type | Receives |
|---|---|---|
| iNPH patients | Active comparator | Procedure: Shunt surgeryShunt operation |
| Healthy Individuals | No intervention | –Healthy individuals without any neurological disease. |
Who may qualify
- Ages
- 61 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Shunt surgeryShunt operation | Procedure or surgery | iNPH patients |
Primary outcome
White Matter Changes in Idiopathic Normal Pressure Hydrocephalus: A Diffusion Tensor Imaging Study.
Time frame: 2 years
Franctional Anisotropi and Apparent Diffusion Coefficient changes before and 3 months after the shunt surgery and correlation with clinical data. All data will be compared with results from the Healthy individual group.
1 secondary outcome
Gastrointestinal and urinary symptoms in idiopathic Normal Pressure Hydrocephalus.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 32678296Eleftheriou A, Blystad I, Tisell A, Gasslander J, Lundin F. Publisher Correction: Indication of Thalamo-Cortical Circuit Dysfunction in Idiopathic Normal Pressure Hydrocephalus: A Diffusion Tensor Imaging Study. Sci Rep. 2020 Jul 16;10(1):12014. doi: 10.1038/s41598-020-69149-x.
- Background: PubMed 28817574Keong NC, Pena A, Price SJ, Czosnyka M, Czosnyka Z, DeVito EE, Housden CR, Sahakian BJ, Pickard JD. Diffusion tensor imaging profiles reveal specific neural tract distortion in normal pressure hydrocephalus. PLoS One. 2017 Aug 17;12(8):e0181624. doi: 10.1371/journal.pone.0181624. eCollection 2017.
- Background: PubMed 27581308Siasios I, Kapsalaki EZ, Fountas KN, Fotiadou A, Dorsch A, Vakharia K, Pollina J, Dimopoulos V. The role of diffusion tensor imaging and fractional anisotropy in the evaluation of patients with idiopathic normal pressure hydrocephalus: a literature review. Neurosurg Focus. 2016 Sep;41(3):E12. doi: 10.3171/2016.6.FOCUS16192.
- Background: PubMed 23728069Nakanishi A, Fukunaga I, Hori M, Masutani Y, Takaaki H, Miyajima M, Aoki S. Microstructural changes of the corticospinal tract in idiopathic normal pressure hydrocephalus: a comparison of diffusion tensor and diffusional kurtosis imaging. Neuroradiology. 2013 Aug;55(8):971-976. doi: 10.1007/s00234-013-1201-6. Epub 2013 Jun 2.
- Background: PubMed 28180932Ege S. [Management of urinary incontinence in a geriatric rehabilitation department : Global urinary incontinence assessment incorporating the International Consultation on Incontinence Questionnare - Urinary Incontinence Short Form (ICIQ-UI SF)]. Z Gerontol Geriatr. 2018 Apr;51(3):301-313. doi: 10.1007/s00391-016-1173-3. Epub 2017 Feb 8. German.
- Background: PubMed 16463856Marmarou A, Black P, Bergsneider M, Klinge P, Relkin N; International NPH Consultant Group. Guidelines for management of idiopathic normal pressure hydrocephalus: progress to date. Acta Neurochir Suppl. 2005;95:237-40. doi: 10.1007/3-211-32318-x_48.
- Background: PubMed 18408356Ishikawa M, Hashimoto M, Kuwana N, Mori E, Miyake H, Wachi A, Takeuchi T, Kazui H, Koyama H. Guidelines for management of idiopathic normal pressure hydrocephalus. Neurol Med Chir (Tokyo). 2008;48 Suppl:S1-23. doi: 10.2176/nmc.48.s1.
- 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. This study is not recruiting at the moment.
Fredrik Lundin, MD, PhD study director
Department of Neurology and Department of Biomedical and Clinical Sciences, Linköping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shunt surgery in people with Fecal Incontinence with Fecal Urgency and Urine Incontinence, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 6 Mar 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
White Matter Changes in Idiopathic Normal Pressure Hydrocephalus: A Diffusion Tensor Imaging Study. (time frame: 2 years). 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 NCT04808076, which also lists 7 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 6 Mar 2025.