NCT01389921

Brief Summary

The purpose of this study is to investigate afferent and cortical activities during bladder filling under different stimulations of the lower urinary tract. The participants of the study are healthy test persons and patients with overactive bladder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

June 28, 2011

Last Update Submit

July 19, 2019

Conditions

HealthyNonneurogenic Neurogenic Bladder DysfunctionNeurogenic Bladder Dysfunction Nos

Keywords

lower urinary tractsensory evoked potentialcontact heat evoked potential stimulationelectroencephalogramcortical processingbladder sensationslower urinary tract dysfunctionoveractive bladder

Outcome Measures

Primary Outcomes (1)

  • Establishment of somatosensory evoked potentials of lower urinary tract stimulations

    EEG recording during electrical stimulation of different locations of the lower urinary tract as well as during electrical and heat stimulation at the tibial and pudendal nerve and S3 dermatome.

    3 times on an average period of three months

Study Arms (3)

healthy testpersons

EXPERIMENTAL

Electroencephalography recording during electrical stimulation of different locations of the lower urinary tract as well as during electrical and heat stimulation at the tibial and pudendal nerve and S3 dermatome.

Other: Electroencephalography

patients with non-neurogenic OAB

EXPERIMENTAL

Electroencephalography recording during electrical stimulation of different locations of the lower urinary tract as well as during electrical and heat stimulation at the tibial and pudendal nerve and S3 dermatome.

Other: Electroencephalography

patients with neurogenic OAB

OTHER

Electroencephalography recording during electrical stimulation of different locations of the lower urinary tract as well as during electrical and heat stimulation at the tibial and pudendal nerve and S3 dermatome

Other: Electroencephalography

Interventions

ElectroencephalographyOTHER

Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials

healthy testpersonspatients with neurogenic OABpatients with non-neurogenic OAB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right-handed
  • Written informed consent

You may not qualify if:

  • Any psychological diseases
  • Any renal, cardiac, and pulmonary diseases
  • Pregnancy or breastfeeding
  • Problems keeping calm for 60 minutes in the sitting position
  • Medication influencing EEG or bladder function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spinal Cord Injury & Research, University of Zürich, Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (3)

  • Gregorini F, Knupfer SC, Liechti MD, Schubert M, Curt A, Kessler TM, Mehnert U. Sensory evoked potentials of the bladder and urethra in middle-aged women: the effect of age. BJU Int. 2015 Apr;115 Suppl 6:18-25. doi: 10.1111/bju.13066.

    PMID: 25626360BACKGROUND

  • Knupfer SC, Liechti MD, Gregorini F, De Wachter S, Kessler TM, Mehnert U. Sensory function assessment of the human male lower urinary tract using current perception thresholds. Neurourol Urodyn. 2017 Feb;36(2):469-473. doi: 10.1002/nau.22956. Epub 2016 Jan 15.

    PMID: 26773330BACKGROUND

  • Gregorini F, Wollner J, Schubert M, Curt A, Kessler TM, Mehnert U. Sensory evoked potentials of the human lower urinary tract. J Urol. 2013 Jun;189(6):2179-85. doi: 10.1016/j.juro.2012.11.151. Epub 2012 Nov 30.

    PMID: 23206421BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ulrich Mehnert, Dr.

    Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Executive physician

Study Record Dates

First Submitted

June 28, 2011

First Posted

July 8, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2011

Study Completion

April 1, 2014

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

CH(1)