Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function
Primary Purpose
Lower Urinary Tract Symptoms
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
EEG and EP measurement
Sponsored by
About this trial
This is an interventional basic science trial for Lower Urinary Tract Symptoms
Eligibility Criteria
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
Sites / Locations
- Universitätsklinik BalgristRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healthy volunteers
Patients with LUTS
Patients with LUTS and treatment
Arm Description
Healthy volunteers
Patients with LUTS
Patients with LUTS and treatment
Outcomes
Primary Outcome Measures
N1latency of LUT SEPs
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02272309
Brief Title
Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ulrich Mehnert
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Healthy volunteers
Arm Title
Patients with LUTS
Arm Type
Experimental
Arm Description
Patients with LUTS
Arm Title
Patients with LUTS and treatment
Arm Type
Experimental
Arm Description
Patients with LUTS and treatment
Intervention Type
Procedure
Intervention Name(s)
EEG and EP measurement
Primary Outcome Measure Information:
Title
N1latency of LUT SEPs
Time Frame
2-3 measurements within 4-16 weeks from first exam
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Van der Lely
Phone
+41 44 510 72 16
Email
stephanie.vanderlely@balgrist.ch
Facility Information:
Facility Name
Universitätsklinik Balgrist
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Mehnert, Dr.
Phone
+41 44 386 39 07
Email
ulrich.mehnert@balgrist.ch
12. IPD Sharing Statement
Citations:
PubMed Identifier
27887601
Citation
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.
Results Reference
derived
Learn more about this trial
Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function
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