Sacral Neuromodulation for Neurogenic LUT Dysfunction

Study Overview
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Brief Summary
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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.

Official Title
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Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction: A Randomized, Placebo-controlled, Double-blind Clinical Trial

Conditions
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Refractory Neurogenic LUTD

Intervention / Treatment
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* Device: Turning OFF the neuromodulator
* Device: Turning ON the neuromodulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sacral neuromodulation ON<br>active sacral neuromodulation (neuromodulator ON) | Device: Turning ON the neuromodulator<br> <br> |
| Placebo Comparator: sacral neuromodulation OFF<br>placebo sacral neuromodulation (neuromodulator OFF) | Device: Turning OFF the neuromodulator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with successful sacral neuromodulation | success versus failure (yes/no variable) | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacral neuromodulation, neurogenic lower urinary tract dysfunction