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Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02272309
Enrollment
124
Registered
2014-10-22
Start date
2014-05-31
Completion date
2023-12-31
Last updated
2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Symptoms

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.

Interventions

PROCEDUREEEG and EP measurement

Sponsors

Ulrich Mehnert
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frame
N1latency of LUT SEPs2-3 measurements within 4-16 weeks from first exam

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026