Comparatve study between self catheterisation with a silicone catheter and a stainless steel catheter assessing bladder infection rate in female patients who are self catheterising.

Comparative Multicentre trial assessing the incidence of urinary tract infections using the conventional silicone catheter with a stainless steel catheter for intermittent self catheterising in patients who have a neurogenic bladder and a post void residual volume of >100mls

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000344998

Enrollment

Registered

2011-04-01

Start date

2011-06-01

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 has been designed is to compare the incidence of urinary tract infections (UTI) in 50 female patients who need to self catheterise to properly empty their bladders. Participants in this study will be monitored for a 3 month period for frequency of UTIs, ease of use and continence specific quality of life while using the Nelaton silicone catheter, followed by a 3 month study period using a surgical stainless steel catheter assessing the same parameters for intermittent self catheterising. During the 6 month study peroid, participants will be asked to keep a urinary diary and they will be monitored closely for urinary tract infection (UTI). If a participant develops symptoms of UTI, a urine sample will be obtained and sent for urinalysis. If positive they will be commenced on appriopriate antibiotics and a decision will be made whether the patient needs to be withdrawn from the study. At the end of the study, each participant will be asked to complete a patient satisfaction survery and continence specific quality of life questionnaire.

Interventions

This is an extenson of a previous study registration number: ACTRN12610000637044. The previous study was titled "A comparative study between the use of the conventional silicone catheter and the surgical stainless steel catheter". The previous study only enrolled 10 participants to trial the catheter. The participants who were involved in the study reported that the surgical stainless steel catheter improved bladder emtpying, reduced time to void, did not need lubrication and it was easier to carry around. This present study has been designed to further evaluate incidence of infection, ease of use and continence specific quality of life in 50 female pateints comparing a conventional silicone catheter with a surgical stainless steel catheter. Patients wil be asked to catheterise for 3 months using the silicone catheter followed by 3 months with the stainless steel catheter, catheterising at their usual frequency ie 3-4 times per day

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 75 Years

Healthy volunteers

Inclusion criteria

(1) Female patients aged 16 - 75. (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 associated with self-catheterisation.

Exclusion criteria

(1) History of urethral trauma/stricture. (2) Inadequate upper limb dexterity to be able to self-catheterise. (3) No history of infections in the preceding 14 days.

Outcome results