Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function
- Conditions
- Lower Urinary Tract Symptoms
- Registration Number
- NCT02272309
- Lead Sponsor
- Ulrich Mehnert
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method N1latency of LUT SEPs 2-3 measurements within 4-16 weeks from first exam
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitätsklinik Balgrist
🇨🇭Zurich, Switzerland
Universitätsklinik Balgrist🇨🇭Zurich, Switzerland