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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
| Swiss Paraplegic Research, Nottwil | NETWORK |
| Cantonal Hospital of St. Gallen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sacral neuromodulation ON | Active Comparator | active sacral neuromodulation (neuromodulator ON) |
|
| sacral neuromodulation OFF | Placebo Comparator | placebo sacral neuromodulation (neuromodulator OFF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turning OFF the neuromodulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with successful sacral neuromodulation | success versus failure (yes/no variable) | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Centre Nottwil | Nottwil | Canton of Lucerne | 6207 | Switzerland | ||
| Cantonal Hospital of St. Gallen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38319849 | Derived | 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. | |
| 25123172 |
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|
| Turning ON the neuromodulator | Device |
|
| Sankt Gallen |
| Canton of St. Gallen |
| 9007 |
| Switzerland |
| University Hospital Inselspital Berne | Bern | 3000 | Switzerland |
| University of Zurich, Balgrist University Hospital, Spinal Cord Injury Center | Zurich | 8008 | Switzerland |
| Knupfer 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. |