Completed

NCT Number: NCT02165774

Sacral Neuromodulation for Neurogenic LUT Dysfunction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Refractory Neurogenic LUTD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Centre Nottwil, Nottwil, Canton of Lucerne, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Turning OFF the neuromodulator

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.

Turning ON the neuromodulator

Device

Primary outcomes

Number of patients with successful sacral neuromodulation

Time frame: 2 months

success versus failure (yes/no variable)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

Cantonal Hospital of St. Gallen
Insel Gruppe AG, University Hospital Bern
Swiss Paraplegic Research, Nottwil

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Jun 17, 2014
Registry last updated: Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.