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Sacral Neuromodulation for Neurogenic LUT Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02165774
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
Swiss Paraplegic Centre Nottwil
Cantonal Hospital of St. Gallen
Information provided by (Responsible Party):
University of Zurich

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : April 2012
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of patients with successful sacral neuromodulation [ Time Frame: 2 months ]
    success versus failure (yes/no variable)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165774


Locations
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Switzerland
Swiss Paraplegic Centre Nottwil
Nottwil, Luzern, Switzerland, 6207
Cantonal Hospital of St. Gallen
St. Gallen, Saint Gallen, Switzerland, 9007
University Hospital Inselspital Berne
Berne, Switzerland, 3000
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02165774    
Other Study ID Numbers: EK 2012 0048
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by University of Zurich:
sacral neuromodulation, neurogenic lower urinary tract dysfunction
Additional relevant MeSH terms:
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Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs