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Clinical Trials/NCT02272309
NCT02272309
Completed
Not Applicable

Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

Ulrich Mehnert1 site in 1 country124 target enrollmentMay 2014
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ConditionsLower Urinary Tract Symptoms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
Ulrich Mehnert
Enrollment
124
Locations
1
Primary Endpoint
N1latency of LUT SEPs
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Ulrich Mehnert

Dr. med.

University of Zurich

Eligibility 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,

Outcomes

Primary Outcomes

N1latency of LUT SEPs

Time Frame: 2-3 measurements within 4-16 weeks from first exam

Study Sites (1)

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