Clinical trial NCT02165774: Sacral Neuromodulation for Neurogenic LUT Dysfunction
Official title: Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction: A Randomized, Placebo-controlled, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Neurogenic LUTD
Keywords: sacral neuromodulation, neurogenic lower urinary tract dysfunction
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Swiss Paraplegic Research, Nottwil
name: Cantonal Hospital of St. Gallen
First posted: 2014-06-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of patients with successful sacral neuromodulation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre Nottwil
state: Luzern
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital of St. Gallen
state: Saint Gallen
city: Berne
country: Switzerland
facility: University Hospital Inselspital Berne
city: Zurich
country: Switzerland
facility: University of Zurich, Balgrist University Hospital, Spinal Cord Injury Center
Study officials:
References:
citation: 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.