NCT01297673

Brief Summary

The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
7 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

7 months

First QC Date

February 16, 2011

Last Update Submit

December 15, 2016

Conditions

Keywords

vesico-ureteral refluxneurogenic bladder dysfunctionspinal cord injury

Outcome Measures

Primary Outcomes (1)

  • Incidence and degree of vesico ureter renal reflux

    video urodynamic, ultrasound examination

    average: yearly scheduled control

Secondary Outcomes (6)

  • pdet (cmH2O)

    average: yearly scheduled control

  • Medication

    average: yearly scheduled examination

  • possible complications

    average: yearly scheduled examination

  • maximum cystometric capacity

    average: yearly scheduled control

  • compliance mL/cmH2O

    average: yearly scheduled control

  • +1 more secondary outcomes

Study Arms (1)

Spinal cord injury

Patients with neurogenic lower urinary tract dysfunction due to spinal cord injury with regular urodynamic examination

Procedure: video-urodynamic examination

Interventions

Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics

Spinal cord injury

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 Genders Eligibility: female and male

You may qualify if:

  • Spinal cord injury
  • 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

Vesico-Ureteral RefluxSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
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

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations