Sacral Neuromodulation for Neurogenic LUT Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-05-31

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.

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Detailed Description

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Conditions

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Refractory Neurogenic LUTD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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sacral neuromodulation ON

active sacral neuromodulation (neuromodulator ON)

Group Type ACTIVE_COMPARATOR

Turning ON the neuromodulator

Intervention Type DEVICE

sacral neuromodulation OFF

placebo sacral neuromodulation (neuromodulator OFF)

Group Type PLACEBO_COMPARATOR

Turning OFF the neuromodulator

Intervention Type DEVICE

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.

Interventions

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Turning OFF the neuromodulator

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.

Intervention Type DEVICE

Turning ON the neuromodulator

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No