Neurogenic Detrusor OveractivityNCT01043848
Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients
A study testing external electric pudendal nerve stimulation in people with Neurogenic Detrusor Overactivity and Spinal Cord Injury, run by Ulrich Mehnert at 3 sites in 2 countries.
Trial summary
Background: Although a small group, special attention has to be given to lower urinary tract (LUT) dysfunctions in spinal cord injury (SCI) patients, as they also suffer under a loss of motor-sensory function and autonomic regulation next to the severe deficiencies in bladder and bowel control. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neurogenic Detrusor Overactivity, Spinal Cord Injury
- What is being tested?
- external electric pudendal nerve stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2009to Oct 2012
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single event traumatic or ischemic Para- or Tetraplegia
- Complete SCI (ASIA A)
- Lesion level between C4 and Th10
- Performance of study treatment and assessments possible according to the study time schedule
- Patient capable and willing of giving written informed consent
Who cannot join
- Nontraumatic Para- or Tetraplegia (i.e. disc herniation, tumor, AV- Malformation, myelitis) exkl. single event ischemic incidences
- Pre- known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
- Peripheral Nerve lesions below the level of lesion (i.e. pudendal nerve impairment, cauda equina syndrome, pre- known Polyneuropathy)
- Severe craniocerebral injury
- Previous or planned intradetrusor injections of botulinum toxin
- Previous or planned surgical therapy for neurogenic detrusor overactivity (e.g. bladder augmentation, Mitrofanoff, sphincter prothesis, sacral neuromodulation, deafferentation, sphincterotomy)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Schweizerisches Paraplegikerzentrum Nottwil
Nottwil, Canton of Lucerne, 6207
Balgrist University Hospital
Zurich, 8008
About this study
Official title: Therapeutic Effects of Early and Late Onset Peripheral Pudendal Neurostimulation on Bladder Function and Autonomic Neuroplasticity in SCI - a Controlled European Multicenter Study
Background: Although a small group, special attention has to be given to lower urinary tract (LUT) dysfunctions in spinal cord injury (SCI) patients, as they also suffer under a loss of motor-sensory function and autonomic regulation next to the severe deficiencies in bladder and bowel control. Autonomic dysregulation linked with LUT dysfunction can cause autonomic dysreflexia with life threatening increases in blood pressure and there is still no concept for an early rehabilitation of bladder function after SCI.
Hypothesis: We assume that inadequate reorganization of nerve fibres in SCI is a reason for spastic bladder dysfunction and vegetative dysregulation and that this can be positively influenced by early neuromodulation. We hypothesized that bladder dysfunction as well as autonomic dysreflexia will be positively affected.
Read more
Specific aims: Evaluation, if external pudendal nerve stimulation (EPS) can positively influence LUT rehabilitation in SCI patients and if early initiation of stimulation is more effective compared to late initiation (after spinal shock).
Experimental design: Prospective multicentre study in 36 SCI patients (24 treatment subjects, 12 control subjects). EPS will be started either within 10 days after SCI (early stim group) or after cessation of spinal shock (late stim group). Effects on spastic bladder function and autonomic disinhibition will be assessed by urodynamics, vegetative tests, and by electrophysiological techniques.
Expected value: If early EPS is effective and complete SCI patients benefit from this intervention; and if early onset of EPS has better and longer lasting effects than late onset stimulation, the findings will be of utmost relevance not only for bladder function but also to alleviate adverse phenomena such as autonomic dysreflexia. Neurostimulation may bear the opportunity to early reshape maladaptive neuroplasticity. This would be proof of an effective modulation and promotion of neuroplasticity, thus opening up new treatment options in the field of paraplegiology.
- Being tested
- external electric pudendal nerve stimulation
- Keywords
- neurogenic detrusor overactivity, neuromodulation, spinal cord injury, pudendal nerve stimulation, videocystometry, neurophysiology, neuroplasticity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external electric pudendal nerve stimulationProcedure or surgery
Also called contic+, tic Medizintechnik GmbH, 46286 Dorsten, Germany
intervention timing: twice daily for 20 minutes during 3 consecutive months.
intervention procedure: electrodes will be placed around the penile shaft (in males) or clips will be directly placed on the clitoris (in females).
intervention device: contic+
stimulation parameters: 10 Hz, 200μs pulse width, 10mA (or less, if too uncomfortable).
| Study group | Role | What they receive |
|---|---|---|
| Early pudendal stimulation | Experimental | Subjects in this arm will start with the intervention within 2 weeks after SCI Receives: Procedure: external electric pudendal nerve stimulation |
| Late pudendal stimulation | Experimental | Subjects in this arm will start with the intervention 12 weeks after SCI Receives: Procedure: external electric pudendal nerve stimulation |
| Control | No intervention | Subjects in this arm will be treated according to standard therapy but will receive no pudendal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Videocystometry
Measured: week 4, 12, 26, 38, 52 after SCI
Secondary outcomes (1)
Neurophysiological measurements (NCV, BCR, SSR)
Measured: week 2, 4, 12, 26, 38, 52 after SCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Poor patient recruitment, necessary number of patients could not be included within the required time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Detrusor OveractivityStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrich Mehnert
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Guttmann, Schweizerisches Paraplegikerzentrum Nottwil, BG Unfallklinik Murnau, University Hospital Heidelberg
- Responsible party
- Sponsor-investigator, Ulrich Mehnert, University of Zurich
- Investigators
- Ulrich Mehnert, MD, Principal investigator, University of ZurichMartin Schubert, MD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043848
- Sponsor's protocol ID
- EMSCI-NU-2/09
- Status last verified
- Jul 2019
- First submitted
- 6 Jan 2010
- Last updated
- 23 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Early and Late Onset Peripheral Pudendal Neurostimulation on Bladder Function and Autonomic Neuroplasticity in SCI - a Controlled European Multicenter Study
- ClinicalTrials.gov ID
- NCT01043848
- Acronym / sponsor ID
- EMSCI-NU-2/09
- Keywords
- neurogenic detrusor overactivity, neuromodulation, spinal cord injury, pudendal nerve stimulation, videocystometry, neurophysiology, neuroplasticity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor patient recruitment, necessary number of patients could not be included within the required time frame
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ulrich MehnertUniversity, hospital or other
- Collaborators
- Institut Guttmann, Schweizerisches Paraplegikerzentrum Nottwil, BG Unfallklinik Murnau, University Hospital Heidelberg
- Study start
- Dec 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Jan 2010 (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.
Background: Although a small group, special attention has to be given to lower urinary tract (LUT) dysfunctions in spinal cord injury (SCI) patients, as they also suffer under a loss of motor-sensory function and autonomic regulation next to the severe deficiencies in bladder and bowel control. Autonomic dysregulation linked with LUT dysfunction can cause autonomic dysreflexia with life threatening increases in blood pressure and there is still no concept for an early rehabilitation of bladder function after SCI.
Hypothesis: We assume that inadequate reorganization of nerve fibres in SCI is a reason for spastic bladder dysfunction and vegetative dysregulation and that this can be positively influenced by early neuromodulation. We hypothesized that bladder dysfunction as well as autonomic dysreflexia will be positively affected.
Specific aims: Evaluation, if external pudendal nerve stimulation (EPS) can positively influence LUT rehabilitation in SCI patients and if early initiation of stimulation is more effective compared to late initiation (after spinal shock).
Experimental design: Prospective multicentre study in 36 SCI patients (24 treatment subjects, 12 control subjects). EPS will be started either within 10 days after SCI (early stim group) or after cessation of spinal shock (late stim group). Effects on spastic bladder function and autonomic disinhibition will be assessed by urodynamics, vegetative tests, and by electrophysiological techniques.
Expected value: If early EPS is effective and complete SCI patients benefit from this intervention; and if early onset of EPS has better and longer lasting effects than late onset stimulation, the findings will be of utmost relevance not only for bladder function but also to alleviate adverse phenomena such as autonomic dysreflexia. Neurostimulation may bear the opportunity to early reshape maladaptive neuroplasticity. This would be proof of an effective modulation and promotion of neuroplasticity, thus opening up new treatment options in the field of paraplegiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early pudendal stimulation | Experimental | Procedure: external electric pudendal nerve stimulationSubjects in this arm will start with the intervention within 2 weeks after SCI |
| Late pudendal stimulation | Experimental | Procedure: external electric pudendal nerve stimulationSubjects in this arm will start with the intervention 12 weeks after SCI |
| Control | No intervention | –Subjects in this arm will be treated according to standard therapy but will receive no pudendal stimulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Single event traumatic or ischemic Para- or Tetraplegia
- Complete SCI (ASIA A)
- Lesion level between C4 and Th10
- Performance of study treatment and assessments possible according to the study time schedule
- Patient capable and willing of giving written informed consent
Key exclusion criteria (6 listed)
- Nontraumatic Para- or Tetraplegia (i.e. disc herniation, tumor, AV- Malformation, myelitis) exkl. single event ischemic incidences
- Pre- known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
- Peripheral Nerve lesions below the level of lesion (i.e. pudendal nerve impairment, cauda equina syndrome, pre- known Polyneuropathy)
- Severe craniocerebral injury
- Previous or planned intradetrusor injections of botulinum toxin
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 |
|---|---|---|
| external electric pudendal nerve stimulationAlso: contic+, tic Medizintechnik GmbH, 46286 Dorsten, Germanyintervention timing: twice daily for 20 minutes during 3 consecutive months. intervention procedure: electrodes will be placed around the penile shaft (in males) or clips will be directly placed on the clitoris (in females). intervention device: contic+ stimulation parameters: 10 Hz, 200μs pulse width, 10mA (or less, if too uncomfortable). | Procedure or surgery | Early pudendal stimulation, Late pudendal stimulation |
Primary outcome
Videocystometry
Time frame: week 4, 12, 26, 38, 52 after SCI
1 secondary outcome
Neurophysiological measurements (NCV, BCR, SSR)
Time frame: week 2, 4, 12, 26, 38, 52 after SCI
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 23 Jul 2019.
Related trials for Neurogenic Detrusor Overactivity
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
RecruitingPhase 1/2
Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
Neurogenic Detrusor Overactivity, Spinal Cord Injuries
Not yet recruiting
TTNS in SCI Patients With Neurogenic Detrusor Overactivity
Spinal Cord Injuries, Neurogenic Detrusor Overactivity
Not yet recruitingObservational study
The Predictive Value of Lower Extremity Hypertonia on Neurogenic Detrusor Overactivity After Spinal Cord Injury
Spinal Cord Injuries (SCI)
Not yet recruitingPhase 1/2
Device for Bladder Control for Men With SCI
Neurogenic Bladder
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.
Ulrich Mehnert, MD principal investigator
University of Zurich
Martin Schubert, MD principal investigator
Balgrist University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external electric pudendal nerve stimulation in people with Neurogenic Detrusor Overactivity and Spinal Cord Injury, run by Ulrich Mehnert at 3 sites in 2 countries.
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 5 inclusion and 6 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, Spain. 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 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?
Videocystometry (time frame: week 4, 12, 26, 38, 52 after SCI). 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 23 Jul 2019.