Role of Residual Urine and Asymptomatic Prostatitis in the Development of Urinary Tract Infections in Spinal Cord Injury

Urinary Tract Infection Clinical Trial

Official title:

Role of Residual Urine and Asymptomatic Prostatitis in the Development of Lower Urinary Tract Infections in Spinal Cord Injury Patients - a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601041
• Other study ID #: 2011-16
• Status: Completed
• Phase: N/A
• First received: May 1, 2012
• Last updated: November 21, 2016
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2016
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

The purpose of this prospective study is to investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization.

The following hypotheses will be tested:

1. The amount of residual urine after intermittent catheterization is significantly greater in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to those without.

2. The incidence of asymptomatic bacterial prostate infections is significantly higher in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to those without.

Description:

To investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization, patients perform self-catheterization twice (before and after urodynamic testing. After each catheterization, residual urine is assessed by ultrasound. Prior to urodynamic testing, prostate massage is performed, bacterial cultures of the fluid and the urine are initiated and the results of these cultures will be analysed .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• male patients with chronic (> 1 year) spinal cord injury

• bladder management by intermittent catheterization

Exclusion Criteria:

• symptomatic urinary tract infection

• prostate pathology

• immunodeficiency

• antibiotic therapy

• missing informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Prostatitis
• Spinal Cord Injuries
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Other:
• sonographic assessment of residual urine, urine culture
residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of residual urine	determined by ultrasound	change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment	No
Secondary	bacterial prostate infection	urinary culture	5-10 minutes before and after prostate massage	No
Secondary	bacteriuria	urine dip stick	5-10 minutes before and after prostate massage	No
Secondary	number of leucocytes in urine	urine dip stick	5-10 minutes before and after prostate massage	No
Secondary	number of erythrocytes in urine	urine dip stick	5-10 minutes before and after prostate massage	No
Secondary	patient characteristics	age	day 0	No
Secondary	type of neurogenic bladder dysfunction		day 0	No
Secondary	type of catheter used for intermittent catheterization		day 0	No
Secondary	annual rate of symptomatic urinary tract infections		day 0	No
Secondary	patient characteristics	sex	day 0	No
Secondary	patient characteristics	time since spinal cord injury	day 0	No
Secondary	patient characteristics	level and degree of spinal cord injury (ASIA impairment score)	day 0	No