Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

Lower Urinary Tract Symptoms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272309
• Other study ID #: KEK-ZH_2013-0518/PB_2016-00498
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Procedure:
• EEG and EP measurement

Locations

Country	Name	City	State
Switzerland	Universitätsklinik Balgrist	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Ulrich Mehnert

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N1latency of LUT SEPs		2-3 measurements within 4-16 weeks from first exam