Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

Sponsor

Ulrich Mehnert (Other)

Overall Status

Recruiting

CT.gov ID

NCT02272309

Collaborator

(none)

330

Enrollment

Location

Arms

116

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms	Procedure: EEG and EP measurement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Healthy volunteers

Healthy volunteers

Procedure: EEG and EP measurement

Experimental: Patients with LUTS

Patients with LUTS

Procedure: EEG and EP measurement

Experimental: Patients with LUTS and treatment

Patients with LUTS and treatment

Procedure: EEG and EP measurement

Outcome Measures

Primary Outcome Measures

N1latency of LUT SEPs [2-3 measurements within 4-16 weeks from first exam]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinik Balgrist	Zurich		Switzerland	8008

Sponsors and Collaborators

Ulrich Mehnert

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulrich Mehnert, Dr. med., University of Zurich

ClinicalTrials.gov Identifier:

NCT02272309

Other Study ID Numbers:

KEK-ZH_2013-0518/PB_2016-00498

First Posted:

Oct 22, 2014

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Additional relevant MeSH terms:

Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Aug 18, 2022