Refractory Neurogenic LUTDNCT02165774
Sacral Neuromodulation for Neurogenic LUT Dysfunction
A study testing Turning OFF the neuromodulator and Turning ON the neuromodulator in people with Refractory Neurogenic LUTD, run by University of Zurich at 4 sites in Switzerland.
Trial summary
Prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 tertiary sacral neuromodulation referral centers in Switzerland (Zürich, Bern, Nottwil, St.Gallen). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Neurogenic LUTD
- What is being tested?
- Turning OFF the neuromodulator and Turning ON the neuromodulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 4 sitesSwitzerland
- Study dates
- Apr 2012to May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory neurogenic LUTD
- Urgency frequency syndrome and/or urgency incontinence refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics)
- Chronic urinary retention refractory to alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
- Combination of urgency frequency syndrome and/or urgency incontinence and chronic urinary retention refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) and alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
- Stable neurological disease/injury for at least 12 months
- Age minimum 18 years
- Informed consent
Who cannot join
- Botulinum A toxin injections into the detrusor and/or urethral sphincter in the last 6 months
- Age under 18 years
- Pregnancy
- Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)
- No informed consent
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
University Hospital Inselspital Berne
Bern, 3000
Swiss Paraplegic Centre Nottwil
Nottwil, Canton of Lucerne, 6207
Cantonal Hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
University of Zurich, Balgrist University Hospital, Spinal Cord Injury Center
Zurich, 8008
About this study
Official title: Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction: A Randomized, Placebo-controlled, Double-blind Clinical Trial
Prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 tertiary sacral neuromodulation referral centers in Switzerland (Zürich, Bern, Nottwil, St.Gallen). Patients with refractory neurogenic LUTD are included and randomized after neuromodulator implantation into sacral neuromodulation ON or sacral neuromodulation OFF (n=30) for a 2 months double-blind phase. In addition to standard neuro-urological assessments, patients who agree will also undergo neurophysiological investigation of the lower urinary tract, i.e. recording of current perception thresholds, sensory evoked potentials, and electroencephalography after stimulation of the urethra and bladder.
- Conditions
- Refractory Neurogenic LUTD
- Being tested
- Turning OFF the neuromodulator, Turning ON the neuromodulator
- Keywords
- sacral neuromodulation, neurogenic lower urinary tract dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turning OFF the neuromodulatorDevice
Turning OFF the neuromodulator in 50% of the patients in a randomized way by an investigator not involved in the assessment of the clinical outcome during the regular outpatient visit 2 months after neuromodulator implantation. It then follows a 2 months double-blind phase. Thereafter, i.e. during the regular outpatient visit 4 months after neuromodulator implantation, the unblinding takes place and in patients with sacral neuromodulation OFF, the neuromodulator is switched ON.
Turning ON the neuromodulatorDevice
| Study group | Role | What they receive |
|---|---|---|
| sacral neuromodulation ON | Active comparator | active sacral neuromodulation (neuromodulator ON) Receives: Device: Turning ON the neuromodulator |
| sacral neuromodulation OFF | Placebo comparator | placebo sacral neuromodulation (neuromodulator OFF) Receives: Device: Turning OFF the neuromodulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful sacral neuromodulation
success versus failure (yes/no variable)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startApr 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractory Neurogenic LUTDStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Swiss Paraplegic Research, Nottwil, Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165774
- Sponsor's protocol ID
- EK 2012 0048
- Status last verified
- Jan 2018
- First submitted
- 2 Jun 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liechti MD, van der Lely S, Knupfer SC, Abt D, Kiss B, Leitner L, Mordasini L, Tornic J, Wollner J, Mehnert U, Bachmann LM, Burkhard FC, Engeler DS, Pannek J, Kessler TM. Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction. NEJM Evid. 2022 Nov;1(11):EVIDoa2200071. doi: 10.1056/EVIDoa2200071. Epub 2022 Jul 7.
PubMed 38319849Knupfer SC, Liechti MD, Mordasini L, Abt D, Engeler DS, Wollner J, Pannek J, Kiss B, Burkhard FC, Schneider MP, Miramontes E, Kessels AG, Bachmann LM, Kessler TM. Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction. BMC Urol. 2014 Aug 13;14:65. doi: 10.1186/1471-2490-14-65.
PubMed 25123172
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction: A Randomized, Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02165774
- Acronym / sponsor ID
- EK 2012 0048
- Conditions
- Refractory Neurogenic LUTD
- Keywords
- sacral neuromodulation, neurogenic lower urinary tract dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Swiss Paraplegic Research, Nottwil, Cantonal Hospital of St. Gallen
- Study start
- Apr 2012
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Jun 2014 (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.
Prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 tertiary sacral neuromodulation referral centers in Switzerland (Zürich, Bern, Nottwil, St.Gallen). Patients with refractory neurogenic LUTD are included and randomized after neuromodulator implantation into sacral neuromodulation ON or sacral neuromodulation OFF (n=30) for a 2 months double-blind phase. In addition to standard neuro-urological assessments, patients who agree will also undergo neurophysiological investigation of the lower urinary tract, i.e. recording of current perception thresholds, sensory evoked potentials, and electroencephalography after stimulation of the urethra and bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sacral neuromodulation ON | Active comparator | Device: Turning ON the neuromodulatoractive sacral neuromodulation (neuromodulator ON) |
| sacral neuromodulation OFF | Placebo comparator | Device: Turning OFF the neuromodulatorplacebo sacral neuromodulation (neuromodulator OFF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Refractory neurogenic LUTD
- Urgency frequency syndrome and/or urgency incontinence refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics)
- Chronic urinary retention refractory to alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
- Combination of urgency frequency syndrome and/or urgency incontinence and chronic urinary retention refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) and alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
- Stable neurological disease/injury for at least 12 months
Key exclusion criteria (5 listed)
- Botulinum A toxin injections into the detrusor and/or urethral sphincter in the last 6 months
- Age under 18 years
- Pregnancy
- Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)
- No informed consent
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 |
|---|---|---|
| Turning OFF the neuromodulatorTurning OFF the neuromodulator in 50% of the patients in a randomized way by an investigator not involved in the assessment of the clinical outcome during the regular outpatient visit 2 months after neuromodulator implantation. It then follows a 2 months double-blind phase. Thereafter, i.e. during the regular outpatient visit 4 months after neuromodulator implantation, the unblinding takes place and in patients with sacral neuromodulation OFF, the neuromodulator is switched ON. | Device | sacral neuromodulation OFF |
| Turning ON the neuromodulator | Device | sacral neuromodulation ON |
Primary outcome
Number of patients with successful sacral neuromodulation
Time frame: 2 months
success versus failure (yes/no variable)
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 9 Jan 2018.
- Derived from this study: PubMed 38319849Liechti MD, van der Lely S, Knupfer SC, Abt D, Kiss B, Leitner L, Mordasini L, Tornic J, Wollner J, Mehnert U, Bachmann LM, Burkhard FC, Engeler DS, Pannek J, Kessler TM. Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction. NEJM Evid. 2022 Nov;1(11):EVIDoa2200071. doi: 10.1056/EVIDoa2200071. Epub 2022 Jul 7.
- Derived from this study: PubMed 25123172Knupfer SC, Liechti MD, Mordasini L, Abt D, Engeler DS, Wollner J, Pannek J, Kiss B, Burkhard FC, Schneider MP, Miramontes E, Kessels AG, Bachmann LM, Kessler TM. Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction. BMC Urol. 2014 Aug 13;14:65. doi: 10.1186/1471-2490-14-65.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turning OFF the neuromodulator and Turning ON the neuromodulator in people with Refractory Neurogenic LUTD, run by University of Zurich at 4 sites in Switzerland.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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?
Number of patients with successful sacral neuromodulation (time frame: 2 months). 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 NCT02165774, which also lists 2 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 9 Jan 2018.