Reduce the risk of bladder infections by using a surgical stainless steel female length catheter to perform intermittent self catheterisation.

A comparative study assessing the incidence of acute urinary tract infection/s using the conventional silicone female length catheter compared to the redesigned surgical stainless steel catheter in female patients with a neurogenic bladder who have to perform intermittent self catheterising.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000637044

Enrollment

Registered

2010-08-03

Start date

2010-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to investigate the incidence of urinary tract infection in people who have a neurogenic bladder with a post void residual volume of greater than 100mls who have to self catheterise to empty their bladder properly. This study will compare the incidence of urinary tract infection using the redesigned surgical stainless steel catheter to the conventional silicone catheter. It will also assess the potential improvement in quality of life and ease of use and storage.

Interventions

All the patients enrolled in the study must be intermittently self catheterising using the conventional female length silicone catheter. This study is going to compare the use of a redesigned surgical stainless steel catheter to the conventional silicone catheter for intermittent self catheterising. The patients enrolled in the study will use the surgical stainless steel catheter for 12 weeks. The surgical stainless steel catheter will be used at the same frequency as the standard silicone catheter for self catheterising. The surgical stainless steel catheter is a multiple use. The same catheter will be used during the 12 week trial. Patients clean the surgical stainless steel catheter with tepid water following use. No sterilising equipment is needed. The surgical stainless steel catheter has been assessed by microbiology. The assessment involed contaminating the catheter with infected urine. A swab was taken and confirmed the microbe. The catheter was cleaned with tepid tap water and the catheter was swabbed again. This swab was negative and confirmed no growth following cleaning of the catheter with tepid tap water. The conventional silicone catheter is also multiple use. If a patient does not have a urinary tract infection, the catheter is replaced daily. If the patient has a urinary tract infection the catheter is replaced after every use. There is one treatment group and the patients act as their own controls due to the small sample size

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 80 Years

Healthy volunteers

Inclusion criteria

(1) Female patients aged 16 - 80. (2) The patient must have a neurogenic bladder and a post void residual volume > 100mls. (3) The patient must be able to self-catheterise without assistance from a carer. (4) There must be a history of recurrent urinary tract infections clinically associated with self-catheterisation.

Exclusion criteria

(1) History of urethral trauma/stricture. (2) Inadequate upper limb dexterity to be able to self-catheterise.

Outcome results