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Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272309
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ulrich Mehnert, University of Zurich

Brief Summary:
Study part 1 will consist of sensory evoked cortical potential (SEP) measurements of the lower urinary tract (LUT) in healthy subjects using different stimulation frequencies from 0.25 to 3Hz to find the most effective frequency in regard to acquisition time for reliable SEP response rates. Study part 2 will consist of a series of consecutive SEP measurements in patients with LUT symptoms during low bladder volume and maximum cystometric capacity to assess reliability of measurements and influence of potential concomitant LUTS treatments.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Procedure: EEG and EP measurement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : May 2014
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Healthy volunteers
Healthy volunteers
Procedure: EEG and EP measurement
Experimental: Patients with LUTS
Patients with LUTS
Procedure: EEG and EP measurement
Experimental: Patients with LUTS and treatment
Patients with LUTS and treatment
Procedure: EEG and EP measurement



Primary Outcome Measures :
  1. N1latency of LUT SEPs [ Time Frame: 2-3 measurements within 4-16 weeks from first exam ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

healthy volunteers:

  • Written informed consent,
  • good mental and physical health,
  • age >18y,

Patients with LUTS and Patients with LUTS and treatment:

  • Written informed consent,
  • age >18y,
  • prior urodynamic investigation,
  • LUTS since >6months with or without detrusor overactivity

Exclusion Criteria:

healthy volunteers:

  • any neurological or urological pathology,
  • current pregnancy or lactation,
  • urinary tract infection,
  • hematuria,
  • any previous pelvic or spine or craniocerebral surgery,
  • any anatomical anomaly of the LUT or genitalia,
  • any metabolic disease,
  • any LUT malignancy,
  • bladder capacity <150mL,
  • SDV at 60mL;

Patients with LUTS and Patients with LUTS and treatment:

  • current pregnancy or lactation,
  • urinary tract infection,
  • gross hematuria

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): NCT02272309


Contacts
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Contact: Stéphanie Van der Lely +41 44 510 72 16 stephanie.vanderlely@balgrist.ch

Locations
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Switzerland
Universitätsklinik Balgrist Recruiting
Zurich, Switzerland, 8008
Contact: Thomas Kessler    +41 44 386 39 07    thomas.kessler@balgrist.ch   
Sponsors and Collaborators
Ulrich Mehnert

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulrich Mehnert, Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT02272309    
Other Study ID Numbers: KEK-ZH_2013-0518/PB_2016-00498
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms