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Completed

NCT Number: NCT02272309

Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinik Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG and EP measurement

Procedure

Primary outcomes

  1. N1latency of LUT SEPs

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

Sponsors and collaborators

Lead sponsor

Ulrich Mehnert

Other

Registry information

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2014
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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