NCT02443870

Brief Summary

The long-term changes of bladder function in individuals with lower urinary tract dysfunction will be investigated. Patients presenting for regular urodynamic examination of bladder function will be included. Bladder diary details and urodynamic data will be collected in order to investigate bladder function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 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

May 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

8.2 years

First QC Date

May 6, 2015

Last Update Submit

September 27, 2023

Conditions

Neurogenic Lower Urinary Tract Dysfunction

Outcome Measures

Primary Outcomes (1)

  • maximal detrusor storage pressure

    12 month after previous investigation

Secondary Outcomes (4)

  • bladder capacity

    12 month after previous investigation

  • bladder compliance

    12 month after previous investigation

  • maximal detrusor voiding pressure

    12 month after previous investigation

  • reflexive bladder volume

    12 month after previous investigation

Other Outcomes (7)

  • gender

    time of injury

  • age

    time of injury

  • lesion level

    time of injury

  • +4 more other outcomes

Eligibility Criteria

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

individuals with neurogenic lower urinary tract dysfunction

You may qualify if:

  • neurogenic lower urinary tract dysfunction
  • urodynamic data

You may not qualify if:

  • duration of neurogenic lower urinary tract dysfunction \< 10 years
  • \< 5 urodynamic follow-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, CH-6207, Switzerland

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 14, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2023

Study Completion

September 1, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

CH(1)