None listed
Conditions
Brief summary
Bladder infections (urinary tract infections or UTI) are amongst the most common infections in women. It is estimated that almost 50% of women will experience at least one episode of UTI in their life time and almost 44% will experience a recurrence within 6 months. These infections can be very troublesome and cause issues like burning sensation when urinating or going very frequently to pass urine, lower abdominal pain, nausea and vomiting, tiredness, days lost from work and sometimes admission to hospitals. While treatments are available to treat these infections, some women will experience several UTI during a year. These women may benefit from preventive treatments. In this study, we are planning to use Methenamine Hippurate or Hiprex which breaks down to a specific chemical in the bladder which can stop the bacteria growing in the bladder; it is not an antibiotic. The rationale in using this medication is that to date there has been no bacterial resistance reported to Hiprex and generally it is a well-tolerated medication with a low side effect profile. In this study, we will compare Hiprex to nitrofurantoin, an antibiotic used for many years to treat and prevent UTI. While effective, nitrofurantoin has the same implications as other antibiotics when used long-term which are resistance and side effects.
Interventions
Arm 1: Methenamine Hippurate tablets, 1 gram twice a day for 6 months
Arm 2: Nitrofurantoin capsules 100 mg once a day for 6 months
As the drugs are all supplied to patients by PBS scripts and they may purchase medications from any pharmacy we won't be able to check their adherence by any means except for patient reported adherence and doctor-patient trust
Sponsors
Mercy Hospital for Women- Urogynaecology department
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 18 years old and above - Have the capacity to give voluntary and informed consent - Recurrent UTI with documented 2 or more infections in the last 6 months or 3 or more in the last 12 months.
Exclusion criteria
*Contraindication to Hiprex: Severe renal or hepatic insufficiency, know allergy. Current use of sulphonamides e.g. sulfamethizole or sulfathiazole *Contraindication to nitrofurantoin: Known allergy to Nitrofurantoin, G6PD enzyme deficiency, active hepatitis, Jaundice, interstitial pneumonitis, pulmonary fibrosis, severe renal insufficiency *Previously tried and failed Hiprex prophylaxis *Pregnancy/Breastfeeding *Underlying renal disease e.g. renal transplant, vesicoureteric reflux *Urethral disorders e.g. stricture, diverticulum *Bladder outlet obstruction e.g. stage 3 or 4 cystocele *Presence of fistula e.g. vesicovaginal or rectovaginal *Urolithiasis *Currently on prophylaxis or recent history of prophylaxis in last 3 months *Permanent urinary indwelling catheter *Poorly controlled diabetes mellitus *Immunosuppressive treatments
Outcome results
None listed