Recurrent uncomplicated urinary tract infection. Infections and Infestations
Conditions
Interventions
Current interventions as of 09/05/2025:
Intravesical Prophylactic Treatment:
- Intravesical antibiotics – 80 mg of Gentamicin diluted to 50 ml with normal saline instilled into the bladder weekly for
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/05/2025: 1. Women (assigned female at birth) with recurrent uncomplicated UTI who have failed first-line treatments (at least three episodes of symptomatic antibiotic-treated urinary infection in the previous 12 months or two episodes of UTI in the last 6 months despite the use of first-line treatments). Failed first-line treatments can include antibiotics, methenamine (antiseptic) or vaginal oestrogen. 2. Women aged >16 years 3. Women able to receive intravesical treatments and take second-line oral antibiotic prophylaxis 4. Women able to give informed consent 5. Women willing to adhere to a 12-month study protocol Previous inclusion criteria: 1. Women with recurrent uncomplicated UTI who have failed first-line treatments (at least three episodes of symptomatic antibiotic-treated urinary infection in the previous 12 months or two episodes of UTI in the last 6 months despite the use of first-line treatments). Failed first-line treatments can include antibiotics, methenamine (antiseptic) or vaginal oestrogen 2. Women aged =16 years 3. Women able to receive intravesical treatments and take second-line oral antibiotic prophylaxis 4. Women able to give informed consent 5. Women willing to adhere to a 12-month study protocol
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 09/05/2025: 1. Women (assigned female at birth) unable to receive intravesical treatments or second-line oral antibiotic prophylaxis 2. Women with structural or functional urinary tract abnormalities considered contributory to rUTI 3. Pregnancy or intended pregnancy in the next 12 months 4. Women who are breastfeeding Previous exclusion criteria: 1. Women unable to receive intravesical treatments or second-line oral antibiotic prophylaxis 2. Women with structural or functional urinary tract abnormalities considered contributory to rUTI 3. Pregnancy or intended pregnancy in the next 12 months 4. Women who are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of symptomatic, antibiotic-treated UTI, self-reported by participants from randomisation to the 6-month treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Incremental cost per quality-adjusted life year (QALY) gained, based on responses to EQ-5D-5L, over 12 months | — |
Countries
United Kingdom
Contacts
Public ContactJanine Bates
Outcome results
None listed