Neurophysiological Assessment of Healthy and Impaired Human Lower Urinary Tract Function

NCT02272309 | Completed

• 1 other identifier: KEK-ZH_2013-0518/PB_2016-00498
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• N1latency of LUT SEPs

  2-3 measurements within 4-16 weeks from first exam

Study Arms (3)

Healthy volunteers

EXPERIMENTAL

Healthy volunteers

Procedure: EEG and EP measurement

Patients with LUTS

EXPERIMENTAL

Patients with LUTS

Procedure: EEG and EP measurement

Patients with LUTS and treatment

EXPERIMENTAL

Patients with LUTS and treatment

Procedure: EEG and EP measurement

Interventions

EEG and EP measurement PROCEDURE

Healthy volunteers; Patients with LUTS; Patients with LUTS and treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulrich Mehnert: lead

Study Sites (1)

Universitätsklinik Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Location

Related Publications (2)

• Liechti MD, van der Lely S, Knupfer SC, Abt D, Kiss B, Leitner L, Mordasini L, Tornic J, Wollner J, Mehnert U, Bachmann LM, Burkhard FC, Engeler DS, Pannek J, Kessler TM. Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction. NEJM Evid. 2022 Nov;1(11):EVIDoa2200071. doi: 10.1056/EVIDoa2200071. Epub 2022 Jul 7.

  PMID: 38319849 BACKGROUND

• 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.

  PMID: 27887601 DERIVED

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: May 1, 2014
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)