Neurogenic Overactive BladderACCEPTANCENCT01023269
Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
A study testing InterStim Therapy in people with Neurogenic Overactive Bladder and Urinary Incontinence, run by MedtronicNeuro at 8 sites in 6 countries.
Trial summary
The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Overactive Bladder, Urinary Incontinence, Detrusor Overactivity
- What is being tested?
- InterStim Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Dec 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incomplete upper motor neuron lesion
- Detrusor overactivity
- Two leaks or two notices of leaks per day
- Mean functional bladder capacity (volume voided per episode) of ≥100 ml
Who cannot join
- Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.
- Degenerative disease of the central nervous system
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
France2 sites
Centre Hospitalier Universitaire de Lyon-Sud
Lyon
Hôpital de la Pitié Salpétrière
Paris
Germany2 sites
Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum
Herne, 44627
Klinik für Urologie Oberarzt-Sekretaria
Tübingen
United Kingdom1 site
National Hospital for Neurology and Neurosurgery
London
About this study
Official title: Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.
Read the detailed description
The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems.
This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.
- Being tested
- InterStim Therapy
- Keywords
- Neurogenic overactive bladder, Urinary incontinence due to incomplete spinal cord injury, Neuromodulation, Neuromodulation for treatment of neurogenic overactive bladder, Patients with Urge urinary incontinence and detrusor overactivity
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStim TherapyDevice
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| ON / OFF | Other | Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks. Receives: Device: InterStim Therapy |
| OFF / ON | Other | Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks. Receives: Device: InterStim Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Bladder Capacity
Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.
Measured: Baseline, 4 weeks after implant, 8 weeks after implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: difficulty in the enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurogenic Overactive BladderStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michele Spinelli, MD, Principal investigator, Ospedale Niguarda Ca' Granda, Milan, ItalyKarel Everaert, MD, Principal investigator, University GhentPhilip Van Kerrebroeck, MD, Principal investigator, Academisch Ziekenhuis, Maastricht, The NetherlandsEmmanuel Chartier-Kastler, MD, Principal investigator, Hôpital de la Pitié Salpétrière, Paris, FranceArndt Van Ophoven, MD, Principal investigator, Marienhospital Herne Klinikum der Ruhr-Universität, Herne, GermanyKarl Sievert, MD, Principal investigator, Klinik für Urologie Oberarzt-Sekretariat, Tübingen, GermanySuzy Elneil, MD, Principal investigator, National Hospital for Neurology and Neurosurgery, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023269
- Sponsor's protocol ID
- 1.02.7004
- Acronym
- ACCEPTANCE
- Status last verified
- Jan 2019
- First submitted
- 30 Nov 2009
- Last updated
- 31 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
- ClinicalTrials.gov ID
- NCT01023269
- Acronym / sponsor ID
- ACCEPTANCE / 1.02.7004
- Keywords
- Neurogenic overactive bladder, Urinary incontinence due to incomplete spinal cord injury, Neuromodulation, Neuromodulation for treatment of neurogenic overactive bladder, Patients with Urge urinary incontinence and detrusor overactivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in the enrolment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 31 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.
Detailed description
The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems.
This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON / OFF | Other | Device: InterStim TherapyStimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks. |
| OFF / ON | Other | Device: InterStim TherapyStimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Incomplete upper motor neuron lesion
- Detrusor overactivity
- Two leaks or two notices of leaks per day
- Mean functional bladder capacity (volume voided per episode) of ≥100 ml
Key exclusion criteria (2 listed)
- Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.
- Degenerative disease of the central nervous system
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 |
|---|---|---|
| InterStim TherapyNeuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence. | Device | OFF / ON, ON / OFF |
Primary outcome
Functional Bladder Capacity
Time frame: Baseline, 4 weeks after implant, 8 weeks after implant
Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Neurogenic Overactive Bladder
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
RecruitingPhase 2
Antibiotic Prophylaxis for Neurogenic Bladder Botox
Neurogenic Bladder, Post-operative Urinary Tract Infections
RecruitingPhase 3
Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction
Spina Bifida
RecruitingObservational study
Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter
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.
Michele Spinelli, MD principal investigator
Ospedale Niguarda Ca' Granda, Milan, Italy
Karel Everaert, MD principal investigator
University Ghent
Philip Van Kerrebroeck, MD principal investigator
Academisch Ziekenhuis, Maastricht, The Netherlands
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterStim Therapy in people with Neurogenic Overactive Bladder and Urinary Incontinence, run by MedtronicNeuro at 8 sites in 6 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 4 inclusion and 2 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Germany, Belgium, Italy, Netherlands and 1 more country. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Bladder Capacity (time frame: Baseline, 4 weeks after implant, 8 weeks after implant). 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 31 Jan 2019.