NCT01297660

Brief Summary

Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

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

January 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

February 16, 2011

Last Update Submit

December 15, 2016

Conditions

Urinary Bladder Neurogenic Dysfunction

Keywords

neurogenic detrusor overactivitydetrusor sphincter dyssynergiacompliancevideo urodynamicspinal cord injury

Outcome Measures

Primary Outcomes (1)

  • Urodynamic evaluation

    Max. cystometric capacity, compliance, detrusor leak point pressure

    5 years after SCI, yearly thereafter (participants are followed until death)

Secondary Outcomes (2)

  • secondary complications

    5 years after SCI, yearly thereafter (participants are followed until death)

  • imaging of the upper urinary tract

    5 years after SCI, yearly thereafter (participants are followed until death)

Study Arms (1)

patients with SCI for at least 5 years

Ages Eligibility: minimum 18 years Genders Eligibility: female and male

Other: Video-urodynamic examination

Interventions

Video-urodynamic examinationOTHER
patients with SCI for at least 5 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ages Eligibility: minimum 18 years old Genders Eligibility: female and male

You may qualify if:

  • Spinal cord injury for at least 5 years
  • Neurogenic lower urinary tract dysfunction
  • Written informed consent

You may not qualify if:

  • Lower urinary tract dysfunction due to other causes than spinal cord injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder, NeurogenicPatient ComplianceSpinal Cord Injuries

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 SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jens Wöllner, Dr. med.

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 17, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

CH(1)