Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction: A Randomized, Placebo-controlled, Double-blind Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Refractory Neurogenic LUTD
- Sponsor
- University of Zurich
- Enrollment
- 61
- Locations
- 4
- Primary Endpoint
- Number of patients with successful sacral neuromodulation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Number of patients with successful sacral neuromodulation
Time Frame: 2 months
success versus failure (yes/no variable)