Join A Clinical Trial Aimed At Preventing Recurrent UTI With Treatments Directly Into The Bladder
VESPER Trial
For Females Aged 16 Years Or Older Who Experience Recurrent Urinary Tract Infections
Why Is This Trial Being Conducted?
Most women will experience a urinary tract infection (UTI) during their lifetime. Some get repeated episodes which considerably reduce quality of life. This is known as recurrent UTI and is defined as at least two episodes in six months or three or more episodes in a year. Recurrent UTI (rUTI) affects around 600,000 United Kingdom (UK) women and is a very common reason for antibiotic prescription.
Patients with rUTIs that are difficult to control may need treatment given directly into the bladder via a catheter. This is also known as intravesical treatment or bladder instillations. Research to compare how well this approach works in comparison to standard treatment approaches is lacking. For this reason, current clinical guidelines cannot recommend bladder instillations for rUTI. In order to address the gaps in the research, the VESPER trial is comparing two treatments administered directly into the bladder (intravesical treatment) to prevent UTI, against the current recommended treatment approach.
Who Can Join the Trial?
The trial is looking for UK-based, female participants who:
- Are aged 16 years or older
- Have experienced:
- Two episodes of symptomatic UTI in the previous 6 months despite treatment with antibiotics, methenamine (antiseptic) or vaginal oestrogen; Or
- At least three episodes of symptomatic UTI treated with antibiotics, in the previous 12 months;
- Are able to receive treatments inside their bladder (intravesical) and take second-line oral antibiotics as prophylaxis (preventative);
- Are willing to adhere to a 12‐month trial protocol.
The trial is unable to accept participants who:
- Have structural or functional urinary tract abnormalities considered contributory to rUTI.
- Are pregnant or intending to become pregnant in the next 12 months.
- Are breast feeding.
All volunteers will be screened for eligibility before entering the trial. To find out whether you qualify, and how to join the trial, read more below.
How to Join the VESPER Trial
To find out whether you qualify for the trial, there are a few steps to follow:
- Read the information on this page, including the FAQs below, and download the Participant Information Sheet.
- Use the hospital finder map below to locate a trial site near you.
- Note the address and contact information for the site you have selected.
- Download and print this trial information letter to share with your GP.
- Provide the trial information letter and site address/contact information to your GP.
- Ask your GP to refer you to the selected site, if they feel you may be eligible.
What Happens After my GP Sends the Referral?
- Once the referral from your GP has been received by a member of the hospital clinical team they will contact you to ask you some questions. They will check if you are eligible to take part in the trial.
- If the clinical team thinks you may be eligible, they will invite you to come to the hospital clinic to fully assess your eligibility.
- If at this eligibility assessment you have symptoms of a UTI or have had antibiotics of a UTI in the previous 4-weeks you will need to wait for approximately 4-weeks before you can enter the trial.
- If you are assessed as being eligible to take part in the trial you will be asked to complete a consent form.
- Once you have completed the consent form, you will be asked to complete some questionnaires. The doctor/nurse will help you with these questions. You will also be asked to provide a urine sample and a perineal swab sample (optional).
- You will be randomised to one of 3 groups. This means a computer will be used to randomly decide, like tossing a coin, which group you will be assigned to.
Once you and your trial doctor know which group you are in, they will arrange for you to receive your treatment.
Learn More About The Trial
Why is this trial being conducted?
Recurrent UTI (rUTI) is a very common reason for antibiotic prescription. There are first-line preventative treatments for rUTI. These include daily, low-dose, oral antibiotics for 6 months, or oral urinary antiseptic (Methenamine) every day for 6 months, or the use of vaginal oestrogen supplementation. However, these do not work for some women (about 15%).
If first-line treatments don’t work, current guidelines would then recommend a second-line, daily oral antibiotic treatment. Patients with infections that are difficult to control may need treatment given directly into the bladder via a catheter. This is known as intravesical treatment or bladder instillations. Bladder instillations are usually administered as a series of treatments over 6 months.
A survey of urology specialists found that they regularly use bladder instillations as a way of administering treatment for rUTIs. However, the supporting evidence for how well they work is lacking. For this reason, current clinical guidelines can only recommend more (second-line) daily oral antibiotic treatment. The VESPER trial compares two treatments administered directly into the bladder (intravesical treatment) to prevent UTI, against the current recommended treatment of daily oral second-line antibiotics. The trial will compare the number of UTI episodes occurring in each group during the 6-months of treatment. This will show which of the three treatments is best at preventing UTI.
What will happen if I join the trial?
Those who are selected to participate in this trial will be assigned at random to one of three groups. A computer will be used to randomly decide (like tossing a coin) which group you will be assigned to:
GROUP 1: An intravesical antibiotic called Gentamicin is instilled into the bladder. This will occur weekly for month 1, fortnightly for months 2 & 3, and monthly for months 4,5 & 6. This means a total of 11 instillations in six months.
GROUP 2: An intravesical GAG replacement compound will be instilled into the bladder. This will occur weekly for month 1, fortnightly for months 2 & 3 and monthly for months 4,5 & 6. This means a total of 11 instillations in six months.
GROUP 3: A daily low-dose, second-line oral antibiotic treatment will be administered for 6 months. This is the Standard of Care and the oral antibiotics will be prescribed as per NICE antimicrobial prescribing.
The trial will primarily assess the effectiveness of these new preventative treatments for recurrent UTI, and how they compare to current UTI treatment.
Participants allocated to groups 1 and 2 will be asked to visit the clinical site to receive the intravesical instillations. Participants in all groups will also be invited to attend the hospital for follow-up appointments. These will occur at 1-month, 3-months, 6-months and 12-months after entry to the trial.
At these follow-up appointments, the following samples will be collected:
- A mid-stream urine sample (for research purposes).
- A perineal swab (optional) (for research purposes). Your trial team will explain how to do this.
- Blood samples.
You will also be asked to complete a diary and some questionnaires about the treatment, your UTI symptoms, and your quality of life. Your involvement in the trial would last 12 months.
Whilst in the trial, participants will be permitted to use over-the-counter preventative treatments. Examples of these are D-mannose, cranberry supplements and vaginal oestrogen.
The research team will also invite some participants to take part in an interview. This will tell us more about their experience of taking part in the VESPER trial. It will be your choice whether or not you take part in an interview if invited. Further information will be provided to you to help make this decision at the time. The interviews will be conducted over the telephone or by video call (your choice). If you take part in this interview, you will be reimbursed with a £10 gift voucher for your time.
Find A Hospital Trial Site
Hospital Trial Site Referral Clinicians and Addresses
Frequently Asked Questions
Should I join this trial?
Do I have to take part?
No, taking part in the VESPER Trial is entirely voluntary. It is up to you to decide whether or not you wish to take part. Deciding not to take part or to leave the trial early, will not affect the standard of care you receive now or in the future.
You are free to leave or withdraw from the trial at any time, without giving a reason.
What are the possible disadvantages of taking part in this trial?
Feeling as if you are going to be sick (nauseated).
Skin rash (mild allergic reaction).
Urine turning orange/yellow
Cough and shortness of breath.
Jaundice (yellow skin) and liver inflammation (hepatitis).
Tingling and numbness of the hands and feet.
Anaemia (becoming pale and having low blood counts) .
Severe allergic reaction (anaphylaxis).
Feeling as if you are going to be sick (nauseated).
Runny or frequent bowel movements (diarrhoea).
Vaginal thrush in women.
Headache.
Skin rash (mild allergic reaction).
Anaemia (going pale and having low blood counts).
Cough and shortness of breath.
Jaundice (yellow skin) and liver inflammation (hepatitis).
Severe allergic reaction (anaphylaxis).
Tummy upset (crampy abdominal pain).
Runny or frequent bowel movements (diarrhoea).
Vaginal thrush in women.
Skin rash (mild allergic reaction).
Severe bowel inflammation.
Kidney inflammation.
Anaemia (going pale and having low blood counts).
Jaundice (yellow skin) and liver inflammation (hepatitis).
Joint pains.
Severe allergic reaction (anaphylaxis).
Diarrhoea.
Nausea.
Skin rashes.
Vomiting.
Reduced platelet count in the blood.
Bowel inflammation.
Joint pain.
Reduced white cell count in the blood.
Blood disorders.
Swelling of lips/mouth.
Liver disorders.
Inflammation of the kidney.
Seizure.
Severe allergic reaction.
What are the advantages of taking part in this trial?
Are there any costs or payments involved in the trial?
Participation in the VESPER trial will involve visiting the hospital on two additional occasions over and above standard routine care. The trial will provide reasonable travel costs for these research visits up to a maximum of £28 per visit. The trial team will manage any payments to reimburse costs to you. You may be asked to provide receipts for your travel. If you are a resident in England, you may ask to be referred to any consultant in any part of England. However, the above maximum reimbursement for travel still applies. Please see below for information regarding how many times you would need to visit the trial site.
If you take part in an interview, you will be reimbursed with a £10 gift voucher for your time.
Can I participate in a language other than English?
The questionnaires that participants will be asked to complete cannot be translated into languages other than English. This is because they were developed and validated in English.
However, this research aims to be as inclusive as possible. If you wish to complete the questionnaires in another language, you can request this. The trial team will approach NHS translation services that are available within NHS hospitals.
What if I have any questions about the trial?
Who is organising and funding the trial?
What will happen if I join the trial and don’t want to carry on or if I am asked to stop taking part?
You can withdraw (stop) being part of the trial at any time, without giving a reason, but trial data that has already been collected on you will be kept. You can, if you wish, ask for your personal contact details (eg address, telephone number, email address) to be removed. If you make this request, your contact details will be removed within 28 days of the request. However, the research team will need to keep the consent form, which will contain your name.
Withdrawing will not affect the care you receive now or in the future. You will be given options as to whether you wish to partially withdraw or withdraw fully from the trial.
Please see the Participant Information Sheet for more information about withdrawing from the trial. The information sheet also outlines why a participant may be asked to stop the trial.
How many times will I have to go to the trial site?
If you are randomised to groups 1 or 2, which will receive treatment directly into the bladder, you will need to visit the clinical site 12 times in total:
- Weekly for the first month
- Fortnightly for months 2 and 3
- Monthly for months 4, 5 and 6
- Final follow-up in month 12
If you are randomised to the group 3, which will take oral antibiotics, you will need to visit the clinical site four times in total: months 1, 3, 6 and 12.
What will happen to the results of the trial?
How long will I be in the trial?
What if I am pregnant or planning to become pregnant?
If you are pregnant, plan to become pregnant in the next 12 months, or are currently breastfeeding, you will not be eligible to take part in this trial.
If you become pregnant whilst on the trial, you will need to immediately let your GP know and also tell the hospital team who are treating you. Under the supervision of your doctor, you will need to stop taking your trial treatment.