Eligibility

All trials have entry requirements-called inclusion and exclusion criteria-that determine whether someone can take part in the trial. This section describes the criteria we will be using for the RUTI trial.

Inclusion criteria

Women will be eligible for the trial if they are:

• aged over 18 and under 65 years of age

• have reported 3 or more recurrent UTIs in the previous 12 months, where at least one episode has been confirmed as a bacterial UTI by a GP.

The upper age limit for the trial has been chosen because, within Chinese medicine, there are several diagnostic patterns that relate to RUTIs. Women over the age of 65 will tend to present with a different pattern to a younger age group and the standardised herbal remedy may not be appropriate for them.

 

Exclusion criteria

Women will be unable to take part in the trial if they:

 

• have symptoms of complicated UTI’s such as acute pyelonephritis (kidney infection)

• have known liver or kidney disease

• are pregnant or breast feeding

• have diabetes

• are taking drugs which may interact with Chinese herbal medicine: these include cardiac glycosides (Digoxin), warfarin and lithium

• have psychosis, dementia or terminal illness that may prevent completion of symptom diaries.

• have commenced a new treatment (conventional or complementary) for RUTIs in the previous 6 months.

 

During the trial women will be withdrawn from the trial if they develop significantly altered liver or kidney function tests. Any women who also become pregnant during the trial will also be advised to stop taking the CHM and to inform a member of the study team for further advice. If pregnancy is confirmed, the participant will be asked to withdraw from the intervention in the study and asked for their consent to remain for safety monitoring purposes.

 

More information

If you would like more information about the RUTI trial then email Andrew.Flower@soton.ac.uk or you can phone the trial help line on 07530 196142