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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Procedure: EEG and EP measurement

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphanie Van der Lely; Phone Number: +41 44 510 72 16; Email: stephanie.vanderlely@balgrist.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Universitätsklinik Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
N1latency of LUT SEPs	2-3 measurements within 4-16 weeks from first exam

Collaborators and Investigators

• Sponsor: Ulrich Mehnert

Publications and helpful links

General Publications

• van der Lely S, Stefanovic M, Schmidhalter MR, Pittavino M, Furrer R, Liechti MD, Schubert M, Kessler TM, Mehnert U. Protocol for a prospective, randomized study on neurophysiological assessment of lower urinary tract function in a healthy cohort. BMC Urol. 2016 Nov 25;16(1):69. doi: 10.1186/s12894-016-0188-9.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimated): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: KEK-ZH_2013-0518/PB_2016-00498