Intravesical Microdox versus normal saline bladder instillation for recurrent urinary tract infections: A Randomised Controlled Trial.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000997954

Enrollment

276

Registered

2020-10-06

Start date

2021-01-01

Completion date

2022-08-29

Last updated

2020-10-12

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

Conditions

None listed

Brief summary

The aim of this study is to evaluate the effectiveness of microdox bladder rinse in patients with recurrent UTIs. Efficacy will be assessed by the number of symptomatic UTI’s during the 3 month treatment period and 3 months following completion of Microdox. Women must meet criteria for recurrent UTI i.e. > 2 documented symptomatic UTIs in preceding 12 months. We are aiming to exclude catheterised women. This is a multi-centre, double blinded, randomised trial. Intravesical Microdox treatment is superior to intravesical normal saline wash for the prevention of recurrent UTI’s at 6 months. There is currently no human trials using Microdox in the bladder. Most research on Microdox is based on wound care. There is one recent randomized trial using normal saline wash in catheterised patients and the UTI rate decreased markedly. The cost and suffering resulting from Recurrent UTI’s is significant. Hence better treatments of Recurrent UTI’s is desperately needed, particularly treatment that won’t contribute to the growing antibiotic resistance, and we are hoping that Microdox could be the answer.

Interventions

Microdox (Te Arai Biofarma - intravesical catheter rinse) 50ml Intravesical weekly for 12 weeks. The intravesical treatment is administered by a nurse. The patients retains the treatment for as long as possible before they will the pass the treatment by voiding at their own convenience. NB - Microdox is TGA registered as a DEVICE...

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Women >18 years. • Women meeting the criteria for recurrent UTI: > 3 documented symptomatic UTIs in the preceding 12 months or 2 or more UTI’s in the preceding 6 months. • Willing to participate and return for follow up.

Exclusion criteria

• Permanent IDC, ureteric stents or nephrostomy • Foreign body causing obstruction or recurrent infection (e.g. Untreated bladder stones, upper tract stones, mesh).

Outcome results