Sacral Neuromodulation for Neurogenic LUT Dysfunction

Refractory Neurogenic LUTD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165774
• Other study ID #: EK 2012 0048
• Status: Completed
• Phase: N/A
• First received: June 2, 2014
• Last updated: January 8, 2018
• Start date: April 2012
• Est. completion date: May 2017

Study information

• Verified date: January 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Refractory Neurogenic LUTD

Intervention

Device:
• 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.
• Turning ON the neuromodulator

Locations

Country	Name	City	State
Switzerland	University Hospital Inselspital Berne	Berne
Switzerland	Swiss Paraplegic Centre Nottwil	Nottwil	Luzern
Switzerland	Cantonal Hospital of St. Gallen	St. Gallen	Saint Gallen
Switzerland	University of Zurich, Balgrist University Hospital, Spinal Cord Injury Center	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Cantonal Hospital of St. Gallen, Swiss Paraplegic Centre Nottwil, University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with successful sacral neuromodulation	success versus failure (yes/no variable)	2 months