Urodynamic Evaluation in Patients After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Urodynamic Evaluation Neurgenic Bladder in Patients After Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04231474
• Other study ID #: 1/2019CReh
• Secondary ID: 111/19
• Status: Recruiting
• Start date: January 20, 2020
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2020
• Source: Poznan University of Medical Sciences
• Contact: Ewa Chlebus
• Phone: 600195386
• Email: ewachlebus[@]ump.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective study, which analyzed 100 medical histories of patients who were admitted o the Neurological Rehabilitation Ward of the Rehabilitation Clinic in the Orthopedic-Rehabilitation Hospital in Poznan in years 2010-2019.

Description:

All patients considered for the study underwent routine testing: blood counts, urinalysis, urine culture, and sensitivity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: March 1, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

Inclusion Criteria:

• incomplete spinal cord injuries,

• the results of the urodynamic testing (conducted by the same urologist) by admission,

• urine culture test by admission.

Exclusion Criteria:

• complete spinal cord injury

• without urodynamic test in medical documentation by admission,

• without urine culture test by admission,

• with symptomatic urinary tract infection in urodynamic test

Related Conditions & MeSH terms

• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Urodynamics
• Wounds and Injuries

Intervention

Device:
• Urodynamic testing
All data were obtained using the MMS Alfa 4T by the same urologist with use of an 8 Charr catheter.

Locations

Country	Name	City	State
Poland	Department of Rehabilitation and Physiotherapy Rehabilitation,	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urethra sensation	2 - preserved, 1- reduced, 0 - absent	30 days after spinal injury,
Primary	Urethra sensation	2 - preserved, 1- reduced, 0 - absent	after 3 months of rehabilitation
Primary	Intravesical pressure	0- normal, 1- low	30 days after spinal injury,
Primary	Intravesical pressure	0- normal, 1- low	after 3 months of rehabilitation
Primary	Bladder complaince	2- high, 1- reduced	30 days after spinal injury,
Primary	Bladder complaince	2- high, 1- reduced	after 3 months of rehabilitation
Primary	Bladder stability	0 -stable, 1- hyperactive	30 days after spinal injury,
Primary	Bladder stability	0 -stable, 1- hyperactive	after 3 months of rehabilitation
Primary	Bladder sensation	2-preserved,1- reduced, 0- absent	30 days after spinal injury
Primary	Bladder sensation	2-preserved,1- reduced, 0- absent	after 3 months of rehabilitation
Primary	Bladder capacity	ml ( Average, Median, SD)	30 days after spinal injury
Primary	Bladder capacity	ml ( Average, Median, SD)	after 3 months of rehabilitation
Primary	Urine volume	ml ( Average, Median,SD)	30 days after spinal injury
Primary	Urine volume	ml ( Average, Median,SD)	after 3 months of rehabilitation