NCT02165774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

5.1 years

First QC Date

June 2, 2014

Last Update Submit

January 8, 2018

Conditions

Refractory Neurogenic LUTD

Keywords

sacral neuromodulation, neurogenic lower urinary tract dysfunction

Outcome Measures

Primary Outcomes (1)

  • Number of patients with successful sacral neuromodulation

    success versus failure (yes/no variable)

    2 months

Study Arms (2)

sacral neuromodulation ON

ACTIVE COMPARATOR

active sacral neuromodulation (neuromodulator ON)

Device: Turning ON the neuromodulator

sacral neuromodulation OFF

PLACEBO COMPARATOR

placebo sacral neuromodulation (neuromodulator OFF)

Device: Turning OFF the neuromodulator

Interventions

Turning OFF the neuromodulatorDEVICE

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.

sacral neuromodulation OFF
Turning ON the neuromodulatorDEVICE
sacral neuromodulation ON

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

University Hospital Inselspital Berne

Bern, 3000, Switzerland

Location

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

Zurich, 8008, Switzerland

Location

Related Publications (2)

  • Liechti MD, van der Lely S, Knupfer SC, Abt D, Kiss B, Leitner L, Mordasini L, Tornic J, Wollner J, Mehnert U, Bachmann LM, Burkhard FC, Engeler DS, Pannek J, Kessler TM. Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction. NEJM Evid. 2022 Nov;1(11):EVIDoa2200071. doi: 10.1056/EVIDoa2200071. Epub 2022 Jul 7.

    PMID: 38319849DERIVED

  • Knupfer SC, Liechti MD, Mordasini L, Abt D, Engeler DS, Wollner J, Pannek J, Kiss B, Burkhard FC, Schneider MP, Miramontes E, Kessels AG, Bachmann LM, Kessler TM. Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction. BMC Urol. 2014 Aug 13;14:65. doi: 10.1186/1471-2490-14-65.

    PMID: 25123172DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 17, 2014

Study Start

April 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

CH(4)