NCT01773213

Brief Summary

In this randomized, double-blind clinical trial including patients with a neurogenic lower urinary tract dysfunction undergoing urodynamic investigation at the Spinal Cord Injury Center, Balgrist University Hospital, Zürich, we aim to investigate whether the detrusor contraction during the ice-water-test is provoked by the ice water or the rapid filling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

January 14, 2013

Last Update Submit

March 2, 2018

Conditions

Urinary Bladder, NeurogenicNeuropathic Bladder

Keywords

Lower urinary tractBladderNeuropathic bladderOveractive bladder

Outcome Measures

Primary Outcomes (1)

  • Increase of detrusor pressure in cmH20

    Increase of detrusor pressure during the verum ice-water-test and the placebo ice-water-test (intravesical pressure increase during the filling of the bladder with 4°C or 36°C water)

    60 minutes

Secondary Outcomes (3)

  • Sensations (yes/no)

    60 minutes

  • Urinary incontinence

    60 minutes

  • Heart rate

    60 minutes

Study Arms (2)

Bladder dysfunction, ice-water-test

OTHER
Procedure: Ice-water-test

Bladder dysfunction, warm water-test

OTHER
Procedure: Ice-water-test

Interventions

Ice-water-testPROCEDURE
Bladder dysfunction, ice-water-testBladder dysfunction, warm water-test

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • neurogenic lower urinary tract dysfunction
  • urodynamic investigation
  • written informed consent
  • ≥ 18 years old

You may not qualify if:

  • symptomatic urinary tract infection
  • \< 18 years old
  • ≥ 90 years old
  • no written informed consent
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder, NeurogenicUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLower Urinary Tract SymptomsUrological Manifestations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
executive physician

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 23, 2013

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 5, 2018

Record last verified: 2018-03

Locations

CH(1)