Sacral Neuromodulation for Neurogenic LUT Dysfunction

University of Zurich (UZH)

Status: Completed

Conditions: Refractory Neurogenic LUTD

Treatments: Device: Turning ON the neuromodulator; Device: Turning OFF the neuromodulator

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02165774

EK 2012 0048

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

61 participants in 2 patient groups, including a placebo group

sacral neuromodulation ON

Active Comparator group

Description:

active sacral neuromodulation (neuromodulator ON)

Treatment:

Device: Turning ON the neuromodulator

sacral neuromodulation OFF

Placebo Comparator group

Description:

placebo sacral neuromodulation (neuromodulator OFF)

Treatment:

Device: Turning OFF the neuromodulator