Sacral Neuromodulation for Neurogenic LUT Dysfunction

Not Applicable

Completed

• Conditions: Refractory Neurogenic LUTD
• Interventions: Device: Turning ON the neuromodulator; Device: Turning OFF the neuromodulator

• Registration Number: NCT02165774
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sacral neuromodulation ON	Turning ON the neuromodulator	active sacral neuromodulation (neuromodulator ON)
sacral neuromodulation OFF	Turning OFF the neuromodulator	placebo sacral neuromodulation (neuromodulator OFF)

Primary Outcome Measures

Name	Time	Method
Number of patients with successful sacral neuromodulation	2 months	success versus failure (yes/no variable)

Trial Locations

Locations (4)

Cantonal Hospital of St. Gallen; 🇨🇭 St. Gallen, Saint Gallen, Switzerland

University of Zurich, Balgrist University Hospital, Spinal Cord Injury Center; 🇨🇭 Zurich, Switzerland

Swiss Paraplegic Centre Nottwil; 🇨🇭 Nottwil, Luzern, Switzerland

University Hospital Inselspital Berne; 🇨🇭 Berne, Switzerland