Sacral Neuromodulation for Neurogenic LUT Dysfunction

NACompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

May 31, 2017

Study Completion Date

May 31, 2017

Conditions
Refractory Neurogenic LUTD
Interventions
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.

DEVICE

Turning ON the neuromodulator

Trial Locations (4)

3000

University Hospital Inselspital Berne, Bern

6207

Swiss Paraplegic Centre Nottwil, Nottwil

8008

University of Zurich, Balgrist University Hospital, Spinal Cord Injury Center, Zurich

9007

Cantonal Hospital of St. Gallen, Sankt Gallen

All Listed Sponsors
collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

collaborator

Swiss Paraplegic Research, Nottwil

NETWORK

collaborator

Cantonal Hospital of St. Gallen

OTHER

lead

University of Zurich

OTHER

NCT02165774 - Sacral Neuromodulation for Neurogenic LUT Dysfunction | Biotech Hunter | Biotech Hunter