Sacral Neuromodulation for Neurogenic LUT Dysfunction

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT02165774

Collaborator

University Hospital Inselspital, Berne (Other), Swiss Paraplegic Centre Nottwil (Other), Cantonal Hospital of St. Gallen (Other)

Enrollment

Locations

Arms

Duration (Months)

15.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Neurogenic LUTD	Device: Turning OFF the neuromodulator Device: Turning ON the neuromodulator	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sacral neuromodulation ON active sacral neuromodulation (neuromodulator ON)	Device: Turning ON the neuromodulator
Placebo Comparator: sacral neuromodulation OFF placebo sacral neuromodulation (neuromodulator OFF)	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.

Arm

Intervention/Treatment

Active Comparator: sacral neuromodulation ON

active sacral neuromodulation (neuromodulator ON)

Device: Turning ON the neuromodulator

Placebo Comparator: sacral neuromodulation OFF

placebo sacral neuromodulation (neuromodulator OFF)

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.

Outcome Measures

Primary Outcome Measures

Number of patients with successful sacral neuromodulation [2 months]
success versus failure (yes/no variable)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swiss Paraplegic Centre Nottwil	Nottwil	Luzern	Switzerland	6207
2	Cantonal Hospital of St. Gallen	St. Gallen	Saint Gallen	Switzerland	9007
3	University Hospital Inselspital Berne	Berne		Switzerland	3000
4	University of Zurich, Balgrist University Hospital, Spinal Cord Injury Center	Zurich		Switzerland	8008

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT02165774

Other Study ID Numbers:

EK 2012 0048

First Posted:

Jun 17, 2014

Last Update Posted:

Jan 9, 2018

Last Verified:

Jan 1, 2018

Keywords provided by University of Zurich

sacral neuromodulation, neurogenic lower urinary tract dysfunction

Additional relevant MeSH terms:

Neurotransmitter Agents

Study Results

No Results Posted as of Jan 9, 2018