Refractory Neurogenic LUTD
Conditions
Keywords
sacral neuromodulation, neurogenic lower urinary tract dysfunction
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.
Interventions
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.
Sponsors
Insel Gruppe AG, University Hospital Bern
Swiss Paraplegic Research, Nottwil
Cantonal Hospital of St. Gallen
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with successful sacral neuromodulation | 2 months | success versus failure (yes/no variable) |
Countries
Switzerland
Outcome results
None listed