In this study, we are aiming to develop consensus-driven standards for the diagnosis, treatment, and ongoing management of patients with malignant upper urinary tract obstruction (MUUTO).
 

MUUTO is a blockage in the upper part of their urinary tract that some cancer patients can experience. This blockage can occur when cancer presses on or grows into the tubes that carry urine from the kidneys to the bladder. Although it is not known how common MUUTO is, it’s often linked to deterioration of the patient’s condition. MUUTO can happen in many types of cancer. To help relieve symptoms and possibly improve survival, medical staff may use treatments to relieve the blockage. Procedures such as the insertion of a tube into the kidney (a nephrostomy) or a stent can help improve kidney function, ease pain, and treat infections. Despite its seriousness, there’s little clear guidance for medical staff on how best to manage MUUTO. Different medics and hospitals may handle it in different ways, with no agreed standard on when or how to treat it, or which patients would benefit most. This makes it hard for patients and families to make informed choices with their doctors. In order to address this, we plan to distribute a series of anonymous surveys to a panel of medical experts on MUUTO to gather their opinions about how best to manage the condition. It is anticipated that by using this method we will be able to reach agreement on best practices, and create clear, expert-backed guidelines for diagnosing and treating MUUTO. These guidelines will help medical staff to make better, more consistent decisions, and improve care for patients facing this complex condition.
 

The study will utilize the Delphi methodology, a structured process designed to achieve consensus among experts in the field, and often used in healthcare studies. Service users helped develop the research topic and what research questions should be asked.
By gathering insights from experienced clinicians, we aim to improve clinical care pathways and patient outcomes. Before you decide whether to participate, it is important to understand the purpose of the study, what your involvement will entail, and any potential risks or benefits.
 

You have been selected as a participant because of your expertise in urology, oncology, radiology, nursing, or palliative care, with relevant experience in managing malignant upper urinary tract obstruction. Your contribution is vital to ensuring the recommendations are evidence-based, practical, and applicable to real-world clinical practice.

We will invite you to complete two online surveys, and attend a final face-to-face meeting. We will use the online survey platform Qualtrics to develop and distribute surveys, over approximately 1-3 rounds:
 

• First survey (Round 1/R1): We will ask you to vote on the importance of statements regarding the management of MUUTO. We will also ask you to provide your perspective on questions about the management of MUUTO where there is uncertainty amongst clinicians. Finally, you will have the opportunity to provide further suggestions for the management of MUUTO that have not been included. This survey will take approximately 15-20 minutes to complete. The survey will remain open for 2 – 3 weeks and reminders will be sent to anyone who has not responded, to ensure timely participation. After the first round, we will collate responses, and statements that have not met the pre-determined consensus thresholds will be progressed to Round 2, along with summary results from R1.
• Subsequent Rounds: For Round 2 you will have the opportunity to review anonymised summarized responses from the previous round. Also, we will invite you to consider statements that did not meet consensus criteria in R1, re-evaluate each statement's importance and relevance, and provide feedback where necessary.
• Final face-to-face meeting: The final Delphi round will be a virtual face-to-face meeting. At this meeting you will have the opportunity to discuss any statements that have not met consensus criteria in previous rounds or that require further refinement; to ratify statements that met consensus criteria; and to develop recommendations for the way forward.

The study will last for approximately 6 months, and your involvement would last for approximately 3 months.

The main sponsor for this study is North Bristol NHS Trust.

There are minimal risks associated with participation. The primary risk is the time commitment required to complete the survey rounds. While there are no direct benefits to you as an individual participant, your insights will contribute to the development of improved clinical guidelines, ultimately enhancing patient care.

Your participation is entirely voluntary, and you may withdraw at any stage without providing a reason. Withdrawing will not affect your professional standing or any future interactions with the research team. If you withdraw from the study, we will keep and continue to use all your previously collected data. We will, however not collect any further data from you.

Your responses will be treated confidentially and anonymized before analysis. Only members of the research team will have access to your data. Findings from the study may be published in peer-reviewed journals or presented at conferences, but no identifiable information will be disclosed. We may share anonymised information with others in the future. Dating sharing with other researchers is important to ensure that research is open to peer scrutiny, to optimise the use of good quality research data and to support policy and other decision-making. The Chief Investigator is the data custodian.

We will need to use information from you for this research project. This information will include your name, location and email address.
People will use this information to do the research or to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study, unless you have provided consent for this.

Your data will not be shared outside the UK.

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. You have the right to ask us to remove, change or delete data we hold about you for the purposes of the study. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.

You can find out more about how we use your information:
• by asking one of the research team;
• by sending an email to Helen Williamson (Head of Information Governance) at helen.e.williamson@nbt.nhs.uk, or
• by ringing us on 0117 4147934

If you have a concern about any aspect of this study, you should ask to speak to the study researcher first who will do their best to answer your questions. If you wish to complain formally, you can do this through the National Health Service complaints procedure, using the Patient Advice and Liaison Service (PALS http://www.pals.nhs.uk/). Their contact number is 0117 414 4569. This study does not involve any tests or treatment and it is highly unlikely that you will be harmed during the research. If something does go wrong and this is due to someone’s negligence, then you may have grounds for legal action for compensation against the NHS or the trial’s sponsor organisation North Bristol NHS Trust. You may have to pay your legal costs. The normal NHS complaints mechanisms will always be available to you.

The study results will be presented at research meetings, and published in scientific journals. We will also make the results widely available to the public. You will not be identified in any report or publication.

If you wish to take part, please access the link to an online consent form. After completion of the consent form please proceed to the first survey. Thank you very much for considering taking part in our research.

Choose foods which are less than 0.5g of fat per serving. Remember that most of the fat in the diet is LCT and this will be called “total fat” on the nutrition label. Be aware of the portion size on the plate, it could be different to the suggested serving size on the label.

If you are an inpatient, request a review with a Dietitian to discuss the choices from the menu.

(The menu is changed twice a year).

You should allow at least 1 hour 15 minutes for the test. You can eat and drink as normal before the test, but we would like you to come with your bladder comfortably full.

If you are currently taking any of the below tablets for your bladder symptoms you will need to stop taking these 7 days before your test unless you have been told otherwise:

• Vesicare/solifenacin.
• Regurin/trospium chloride.
• Detrusitol/tolterodine.
• Oxybutynin.
• Betmiga/mirabegron.

Please complete the three day bladder diary and the questionnaires sent with your appointment letter. You must bring both of them with you to the clinic.

Before the test, please let us know:

• If you have any allergies, especially to latex.
• If you have any problems with your mobility.
• If you feel you may have a urine infection. We are unable to perform urodynamics if you have a urine infection and have symptoms (for example foul-smelling urine or a burning sensation when you urinate).

If you are prone to urinary tract infections, please ensure you get your urine checked by your GP surgery five working days before the appointment so that it can be treated before your appointment.

What the urodynamics test involves

After you arrive, a healthcare professional will explain the test to you and ask some questions about the symptoms that you have been experiencing. You can ask any questions you have about the test.

You will then be asked to sign a consent form to make sure that you understand the procedure, the reasons why it is being done and any potential side effects.

In privacy, you will be asked to change and remove the lower half of your clothing (trousers/skirt/underwear). You will be given a hospital gown to change into and once you are on the couch you will be covered with a sheet.

The healthcare professional will also ask you to pass urine into a special toilet (flowmeter). This measures how fast the flow of your urine is and allows us to check you don’t have a urine infection.

After you have done this, the healthcare professional may examine you. This will include an internal examination, with a chaperone present.

During the test

You will be lying on a couch before one or two small tubes

(no more than 3mm in diameter) will be passed into your bladder. Another small tube will be placed into your rectum (back passage). If you do not have a rectum because you have had surgery and have a colostomy or stoma then that can be used, or the vagina can also be used as an alternative.

These tubes allow us to take measurements both inside and outside the bladder. You will then be asked to sit or stand and your bladder will be slowly filled with water through the tube until you feel full. If you are unable to sit or stand then you will remain lying down on the couch.

You will be asked to cough several times during the test to check the tubes are working. You will also be asked a series of questions such as your first desire to pass urine or whether you experience any urgency.

Once your bladder is comfortably full, one of the bladder tubes will be removed. The tube in your rectum and the very tiny tube in your bladder will be left in. You will then be asked to pass urine and the healthcare professionals will leave the room during this time.

After the test

You will be given time to get dressed in privacy after the test and the results will be explained to you. At this point, you will have the opportunity to ask any questions you may have.

A report will be written and a copy will be sent to your GP, the person who referred you, and yourself.

After the test, you may experience some discomfort where the tubes have been for a short time, but this should settle down. We suggest that you drink extra water during the 24 hours after the test to decrease the chances of you developing an infection.

Video urodynamics is similar to standard urodynamics (described above please read and follow the ‘before the test’ guidance above), however, we also take X-ray pictures of your bladder. Instead of using salt water to fill your bladder, we use an iodine-based fluid (this allows us to see your bladder on X-ray).

Before the test, please also let us know:

• If there is any possibility that you are pregnant as we are unable to perform the test if you are. We may also perform a pregnancy test on the day of your appointment.
• If you are allergic to Iodine.

What the urodynamics test involves

Unlike standard urodynamics, because we need to X-ray your bladder when you pass urine, we have to remain in the room. We are as discreet as possible and stay behind the curtains when possible.

NHS website

More information about COPD.

Chronic obstructive pulmonary disease (COPD) - NHS

Asthma and Lung UK

More information about COPD.

Chronic obstructive pulmonary disease (COPD) | Asthma + Lung UK

Right Breathe

Information about how to use your inhalers correctly.

RightBreathe

Support to stop smoking

Try the NHS Quit Smoking app, speak to your local pharmacy or GP, or find out about options for support in your area.

Quit smoking - Better Health - NHS

IAPT Talking Therapies

Get help with your mental health through NHS talking therapies.

NHS Talking Therapy | Vita Health Group

If you have any concerns about the service that the nurses or doctors cannot resolve, you can contact our Patient Advice and Liaison Service (PALS).

PALS offer support and assistance for patients and their families. You can also share positive comments with them about your care.

• Phone: 0117 414 4569 (09:00 to 16:00)
• Email: PALS@nbt.nhs.uk

Figures from a trial being led by NHS Blood and Transplant and the University of Oxford show one in three expectant mothers will develop anaemia.

It is a condition where the blood produces a lower-than-normal amount of red blood cells and can be linked to stillbirth, postnatal depression and haemorrhages.

The research team is working with maternity wards across the UK to carry out a study by giving pregnant women an iron supplement to see if it helps.

The trial is being funded by the National Institute for Health and Care Research (NIHR) and will involve giving half the mothers taking part one iron supplement a day and the other half a placebo.

Researchers are working with up to 50 maternity wards across the country.

PANDA, is open to women who are in the first 16 weeks of pregnancy with a single baby and women can ask their healthcare professional for more information or ask about taking part.

Prof Simon Stanworth is a consultant haematologist at NHS Blood and Transplant in Oxford and is running the trial.

About the programme - Clinical Trials Unit - NHS Blood and Transplant

Principal Investigator – Dr Christy Burden

Start date - 01/03/2024

Planned end date – 30/08/2026

Local Ref – 5707

The Generation Study is a national research study that will sequence the genomes of 100,000 newborn babies to test for more than 200 rare and treatable genetic conditions. 

Identifying these conditions shortly after a baby is born, rather than when symptoms might appear later in childhood, means families can receive support, monitoring, and treatment much earlier. Early, effective intervention can help to prevent longer term health problems associated with certain conditions, keeping children out of hospital, and helping them live healthier lives. 

The Generation Study, led by Genomics England in partnership with NHS England, will see parents offered whole genome sequencing using blood samples taken from the umbilical cord shortly after birth.

In Bristol, Southmead Hospital (North Bristol NHS Trust) and St Michael’s Hospital (University Hospitals Bristol and Weston NHS Foundation Trust) are among more than 20 hospitals nationally taking part.

Women planning to give birth at home may also take part in the study. Expectant parents will be informed about the Generation study during pregnancy, and if interested, a research midwife will have a detailed conversation with them to decide if they want to take part. Taking part is voluntary and free. Soon after birth, an NHS doctor, nurse, or midwife will check with parents that they are still happy for their baby to be tested, and a blood sample will be taken and sent to a laboratory for whole genome sequencing.    

Results are then reviewed by NHS genomic scientists. The aim is to share results with parents within 28 days if a condition is suspected, or within a few months if no conditions are suspected. 

If a newborn baby is identified as having a treatable childhood condition through the genome sequencing, families and carers will be provided with further NHS testing to confirm a diagnosis and will receive ongoing support and treatment from the NHS. 

The study will also gather genomic data for wider research purposes, allowing a better understanding of rare genetic conditions. It will also potentially pave the way for new diagnostic tools and treatments and improvements in existing therapies.

In addition, the Generation Study will explore the risks and benefits of storing an individual’s genome over their lifetime. This could allow it to be reanalysed later in life if needed, enabling access to new developments in genomics.

For further information on the Generation Study, visit: www.generationstudy.co.uk

Principal Investigator – Dr Christy Burden 

Planned end date – Currently 31/12 2026.

Local Ref – 5527

A team of researchers and clinician are conducting a study of the use of a medication called Pravastatin by pregnant women who have been identified as being at higher risk of their babies being born too early (preterm birth).

Preterm birth is birth that happens before 37 weeks of pregnancy. It affects around seven out of every 100 babies born in the UK. We do not fully understand why some babies are born too early and at present there are few effective treatments to prevent this from happening. Research shows it is likely that early labour may occur in some pregnancies because of inflammation in the mother’s body. Taking a medication that reduces inflammation, such as Pravastatin, could therefore reduce the number of babies being born too early. Pravastatin is a statin, and statins are a group of medicines which are commonly taken to help lower the risk of heart disease and stroke. Statins work by protecting blood vessels and lowering inflammation in the body.

During the past couple of decades, Pravastatin has been used during pregnancy in studies which have investigated whether Pravastatin prevents or treats other problems/complications of pregnancy. In total 1,303 pregnant women took part in these studies, which showed that there were no safety concerns or problems regarding the baby’s development.

In fact, these studies suggested benefits to the baby, as they found evidence that Pravastatin reduced the number of babies born early. This is what PIONEER will now test. Based on this information, we are interested to find out whether treatment with Pravastatin reduces the chance that a woman will give birth early by: 

• extending the length of pregnancy
• reducing the risks associated with babies being born too soon. 

We would also like to find out how Pravastatin might work to reduce early birth by looking at blood samples, vaginal swabs, and stool samples taken from pregnant women who take part in the study.

Everyone who takes part in PIONEER will be randomised into one of two groups: one group will take Pravastatin and the other group will take a placebo (a dummy tablet which looks like Pravastatin but does not contain Pravastatin, only an inactive substance). An equal number of pregnant women will be placed in each group. The aim is to have two groups that are as similar as possible at the start of the study, so that the only thing that differs between the groups is whether they receive the Pravastatin or the placebo. This then allows a fair comparison between the two groups to see if there are differences between the groups in the number of babies born early.

For more information, please visit the study website www.bristol.ac.uk/pioneer

Principal Investigator – Dr Sherif Abdel-Fattah

Planned end date – 31/03/2027.

Local Ref - 5406

Children of the 90s is a group of around 14,500 children born in the Avon area in 1991 and 1992. Scientists have been studying them ever since and are constantly making discoveries that make a difference to lives around the world.

Some now have children of their own, and we want to follow these pregnancies, births and babies. We call this Children of the Children of the 90s, or COCO90s for short. This is the only project we know of that provides scientists with information on three generations, allowing them to study important social and health issues.

If you or your partner are in Children of the 90s and are about to become or are already a parent, we'd love you, your partner and all your children to take part in COCO90s. It doesn’t matter how much or how little you have been involved in Children of the 90s in the past -- this is a new opportunity to be involved in ground-breaking research.

For more information about this study, visit the CoCo90s website.

Project Details
Principal Investigator: Ms Mary Alvarez
Planned end date: Ongoing
Local Ref: 2801

Aim: This research project compares two ways we may adjust a commonly used treatment, called positive end-expiratory pressure (or PEEP), to help premature babies’ lungs in the first few minutes after birth.  

Recruitment:  80 babies born before 29 weeks of pregnancy.

The POLAR Trial is a large clinical trial, being conducted in 25 hospitals around the world, including Australia, Europe, the United Kingdom and the USA.​

​This trial will establish how to best support the fragile lungs of very premature babies born between 23 and 28 weeks of pregnancy immediately after birth.​

We are comparing two approaches to PEEP levels given to preterm babies’ lungs at birth. We will put your baby into one of two groups, static or dynamic PEEP.  

All the babies in the same group receive the same treatment.  The results are later compared to see if one is better. 

For more information, please visit the POLAR study website.                                                                                          

Project Details
Principal Investigator: Dr Charles Roeher
Planned end date: 30/06/2026
Local Ref: 5152

Aim: The WHEAT International trial will compare two different approaches, feeding babies or not feeding babies during blood transfusions, to work out which one is better. 

Recruitment: We are including all babies that are born before 30 weeks of pregnancy. The WHEAT study is an opt-out study.  This means that all babies will take part unless you let a member of the neonatal team that you do not wish your baby to participate. 

Both approaches are standard practice in the UK but we don’t how best to feed babies during blood transfusions – some hospitals and doctors stop feeds while other don’t. 

Some babies who are born early can develop a bowel disease called necrotising enterocolitis (NEC) which can be serious and can have long-term effects on how babies grow and develop. We want to know if feeding babies or not feeding babies while they have a blood transfusion changes the number of babies that get NEC.

WHEAT is taking places in neonatal units across the UK and Canada and will involve about 4,500 babies.

Project Details
Principal Investigator: Dr Daniela Vieten-Kay
Planned end date: 31/12/2026
Local Ref: 5236

Aim: The neoGASTRIC study is looking at whether routinely measuring gastric residual volumes (checking what is in the stomach before feeding) helps babies safely get to full feeds more quickly. We are comparing two ways of caring for babies having tube feeds, both ways are standard care commonly used in neonatal units across the UK.

Recruitment: We are including all babies born 6 or more weeks early (before 34 weeks of pregnancy) who require tube feeding unless there is another medical reason why they should not take part. All babies will be in the study unless you let a member of the neonatal team know that you do not wish your baby to take part.

Some doctors and nurses routinely measure gastric residual volumes because they think it might help tell if the baby is coping with their feeds, and may help identify signs of a serious but rare gut disease called necrotising enterocolitis (NEC). Other doctors and nurses think that routinely measuring gastric residual volumes may not be a good idea because it can be inaccurate and we do not know if it does help to identify necrotising enterocolitis (NEC). It also increases the amount of procedures each baby has, and may be uncomfortable for them. Routinely measuring gastric residual volumes may also lead to feeds being reduced or even stopped, this will delay the time it takes for the baby to reach full feeds and might affect how well they grow. It will also mean a baby will need intravenous nutrition for longer which can lead to potential problems like infections.

In the UK about half of doctors and nurses routinely measure gastric residual volumes and about half don’t – so both approaches are standard treatment. 

The study is being run in more than 30 hospitals in the UK and Australia for about 3 to 4 years. We hope to include over 7000 babies in the study (UK and Australia combined).

Project Details
Principal Investigator: Paula Brock
Planned end date: 31/10/2026
Local Ref: 5298

Have you recently received a letter from the NHS breast screening programme inviting you to come for your first screening mammogram?

The NHS provides a breast screening service because early detection of breast cancer saves lives.

The NHS screening programme has been using mammograms to detect cancer since 1988… But still, 30 women die of breast cancer every day in the UK.

The FAST MRI DYAMOND study is looking to see if a new form of MRI scan, called FAST MRI, can pick up aggressive cancers even earlier than mammograms can. 

The NHS already uses breast MRI to detect cancers, but only for women who have a very high likelihood of having breast cancer. For these women, MRI detects breast cancers earlier than mammograms and saves more lives.

The FAST MRI DYAMOND study will be the first UK study to offer a FAST MRI scan to women at normal or average risk, aged 50-52. People invited for their first screening mammogram can take part at 4 NHS breast screening services in England. (Bristol, Cheltenham, Swindon, Truro, London (St George’s & King’s College).

Everyone’s breasts are different, and in addition to how breasts look and feel in real life, they also look different on mammograms.

At age 50-52, breasts can look completely white on mammograms. They can also look completely dark. Both appearances are normal, as are all the different combinations of white and dark in between. These differences are called mammographic density or breast density.

The problem is that breast density can make a small cancer difficult to spot on a mammogram. Breast cancers tend to show as white on mammograms, so you can see how much easier a cancer would be to spot on the dark mammogram on the left than on the white mammogram on the right.

Fortunately, however, FAST MRI works well at detecting small cancers for women of all breast densities. The pink arrow highlights what a cancer, that was completely invisible on the mammogram, looks like on FAST MRI.

Breast screening with mammograms already saves around 1,300 lives each year in the UK by finding cancers that are too small to feel or see. 

FAST MRI could find cancers even earlier for women and our research is designed to find out which women would benefit from breast screening with FAST MRI through finding breast cancer even earlier than mammograms.

We want to find breast cancers earlier because:

• finding cancer early makes it more likely that treatment will be successful
• finding cancer early makes it less likely that a mastectomy will be needed
• finding cancer early makes it more likely that the cancer will be cured.

The only way to discover your breast density is to have a mammogram.

The FAST MRI DYAMOND study wishes to offer a FAST MRI scan to 1000 people who all have average breast density. At age 50-52, four out of every 10 women will have average breast density and could join the FAST MRI DYAMOND Study to have a FAST MRI scan. 

We can only find out whether you can join the study if you give us your contact details and let us know you are happy for us to use your mammogram to measure your breast density.

Research is fundamental to improving treatment and care for patients and the public but it is your choice whether you join the study or not.

If you are having your first screening mammogram and would like to learn more about the FAST MRI DYAMOND study, please fill in a FAST MRI DYAMOND consent to be contacted form, either online or at your mammogram appointment. 

This is the web address of the online form. 

If you would like to ask any questions at all, you will find the telephone number for the nurse from your local research team below this video along with the link to the online form.

Thank you for taking the time to watch this film. Thank you for helping us with this research.

Women with “average” breast density and a clear mammogram may be able to have a FAST MRI. To find this out, we are first inviting women to Stage 1 of the DYAMOND study. 

If you agree to take part in Stage 1, we will send your mammogram to the DYAMOND team at the Royal Surrey NHS Foundation Trust so that they can measure your breast density. We won’t send your mammogram to be measured for 10 working days after we receive your consent. This is in case you change your mind about participating. If you do, please let us know. 

The results will then be sent to Warwick Clinical Trials Unit, to be stored. 

If your mammogram is measured as anything other than average breast density, you will be looked after by the screening service, and you won’t be able to take part in this study. This is because we are only inviting people with “average” breast density to have a FAST MRI. If breast density can't be measured due to having breast implants or for other technical reasons, we will unfortunately not be able to invite you to Stage 2.

If your mammogram measurement is in the “average” breast density group, we will look at your mammogram screening results to check if the screening service says you need any further investigations. This is because in this study, we are only inviting people with clear mammograms to have a FAST MRI.

If you do need some further investigations, the screening service will contact you directly. You won’t be able to have the FAST MRI scan as part of this study. Instead, with your consent, we would like to access your screening and medical records to discover the outcome of your investigations. We will do this for up to 3 years after your first mammogram.

If the screening service says your mammogram needs no further investigations and you are in the average breast density group, we will send you information and an invitation to take part in Stage 2 of the study.

Stage 2 of the FAST MRI DYAMOND study involves having a FAST MRI scan.

Agreeing to take part in Stage 1 does not mean you will automatically have a FAST MRI scan. If the Stage 1 density grading shows you are eligible to take part in Stage 2, you will be invited and can then decide whether to take part or not. 

A member of the research team will contact will contact you to give you information about Stage 2. They will discuss the study with you. If you can have the scan and would like to, they will book you a scan appointment. The scan itself takes just 2-5 minutes, but the whole appointment would last up to 45 minutes. 

No, it’s up to you to decide whether to take part. If you do not want a FAST MRI scan or know you cannot have one, then you can let us know you don’t want to take part. Whether or not you choose to take part, be reassured that your clinical care will not be affected. You will still be offered your routine screening mammograms every 3 years until you turn 71.

In this study we will use information from you and from your medical records. We will only use information that we need for the research study. We will let very few DYAMOND team members know your name or contact details, and only if they really need it for this study. This includes research staff at Royal Surrey Hospital who are providing the Consent Form website. 

Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.  At the end of the study, we will save some of the data for up to 5 years after the study closes, in case we need to check it and for future research (if you have given us permission). We will make sure no-one can work out who you are from the reports we write. Please contact us on the details below for more information about this. 

This study is run by Dr Lyn Jones (Consultant Radiologist) at the FAST MRI Programme Team at North Bristol NHS Trust and a Consultant Radiologist at your local Hospital.

FAST MRI DYAMOND Consent Website

If you have read the patient information above, or have previously read a leaflet given to you in your breast screening mammogram appointment, you can sign up via the FAST MRI DYAMOND Consent Form.

• Botox injections are effective in about 7 in 10 patients (70%), meaning that the urgency and/or urgency incontinence are either significantly better or improved.
• The effects of the injections can last for around 6 to 9 months.
• When your symptoms start to return, you can have further injections.
• There is no limit to how many times you can have your Botox repeated, but you cannot have a repeat within 4 months of each injection.
• Most people find that having repeat injections works well over many years.
• There are no obvious long-term negative effects of having repeated Botox injections into the bladder.

The procedure involves passing a small telescope (cystoscope) into your bladder, through your urethra (water pipe), and giving several injections of Botox into your bladder wall with a needle passed through the cystoscope. Botox paralyses the muscle of the bladder wall and prevents your bladder muscle from contracting and giving you the urgency symptoms.

The aim of the injections is to reduce urinary symptoms such as frequency (passing urine often), urgency and urgency incontinence. It is unlikely that you will see immediate improvement in symptoms and it may take between 2 to 6 weeks to gain maximum benefit. 

The effects of the injections usually last between 6 and 9 months, although this can be variable. Repeat injections will be required each time the effects wear off. This can be offered no more than every 4 months due to the risk of build-up of the toxin in your body.

You are being offered invasive treatment on the basis that you have not had a good response to conservative and medical therapy for your symptoms. 

Overactive bladder may be a lifelong condition and we currently have no cure. All treatments are aimed at helping you cope with the symptoms (see ‘overactive bladder syndrome’ leaflet NBT002734). We recommend that all patients try conservative and medical treatments initially before having invasive procedures. Alternative, conservative measures include:

• Incontinence pads – you may choose not to have any invasive procedures and use incontinence pads to contain your urinary leakage.
• Conservative measures – including weight loss, improving fluid intake and reducing caffeine.
• Bladder training – learning techniques to hold on and override your urgency to pass urine.
• Medicines – these may help if conservative treatment does not work.

Botox injections are usually only tried if the above treatments are not effective. Other treatments that can be used instead of Botox injections include:

• Posterior tibial nerve stimulation (PTNS) – electrical stimulation of the tibial nerve via your ankle can be used, but is not available here in Bristol and not widely available on the NHS as it is not highly recommended by NICE (National Institute for Health and Clinical Excellence).
• Sacral neuromodulation – a device (battery and wire) is implanted in your lower back that sends electrical signals that modulates/stimulates the bladder nerves – a ‘pacemaker’ to the bladder. This is offered here in Bristol and we could make an appointment for you to discuss this in more detail (see NBT003133 leaflet).
• Enterocystoplasty – a major operation that enlarges your bladder using a piece of bowel.
• Urinary diversion (ursotomy) – creating a stoma using a piece of bowel to divert the urine into a bag.

• Botox is not given to patients who have signs or symptoms of urinary tract infection, in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
• It is also contraindicated in patients who cannot perform clean and intermittent self-catheterisation or accept a long-term indwelling catheter if they go into urinary retention.
• Botox must be used with caution in patients with neuromuscular disorders, such as myasthenia gravis, as it may affect the muscles involved in breathing.

This treatment improves the bladder symptoms by essentially paralysing the bladder. This can also mean that the bladder does not empty properly and you may need to self-catheterise. Therefore, prior to your appointment for Botox treatment, if you don’t already know how to self-catheterise, you will be seen by one of the specialist nurses and taught how to perform clean intermittent self-catheterisation (CISC). 

This involves you learning how to pass a small plastic tube into your bladder in order to drain urine. This tube is thrown away once the bladder is drained and the procedure may be repeated several (usually 1-4) times a day. If you are unable to perform self-catheterisation, the alternative would be using a long term urethral or suprapubic catheter, and this can be discussed further with the specialist nurses. CISC may be required until the effect of the Botox wears off.

You will be invited to an appointment either in theatres or the outpatient’s clinic where the procedure can be performed under general, or local, anaesthetic. You will be telephoned by one of the admin team and they will ask you some very important questions and it is important to be honest in your answers or you may be cancelled on the day of the procedure.

On the phone, you will be asked questions such as:

• Do you have a catheter or can you perform CISC?
• Do you have recurrent urinary tract infections? If you suffer with recurrent urinary infections, or in the days prior to the procedure you have symptoms of a urinary tract infection, then you should attend your GP surgery to have your urine checked for an infection and a sample of urine sent to the lab to be analysed by Microscopy, Culture and Sensitivity (MC&S). If you do have an infection, please complete your treatment before coming in for the Botox injections. If your urine test taken in the hospital prior to the procedure is negative for infection and you feel well, we will go ahead with the procedure. If you have an untreated urinary infection on the day of the procedure, it will be cancelled.
• Have you had any other Botox injections anywhere else in the body in the last 3 months? If you had botulinum toxin of any formulation anywhere else in the body within the last 3 months, you will not be able to have it in your bladder unless they are 3 months apart.
• Do you have any mobility issues? We can prepare the appropriate equipment to help you.
• Are you on any medications that thin the blood? These medications may include Anticoagulants such as Clopidogrel, Warfarin, Rivaroxaban, Apixaban, Dabigatran, Edoxaban and a dose of Asprin higher than 75mg. If you are on such medications, then a preoperative assessment will need to be arranged to stop the medication safely prior to the procedure.

• If your procedure is being completed in outpatients under local anaesthesia then you may eat and drink as normal and take your usual medications.
• You will be invited to attend Gate 36 in the urology department.
• On arrival to the department, the nursing team will ask you for a urine specimen. It is important that you do this in the department so it is fresh. The procedure will not be able to go ahead if you are not able to produce a urine sample to rule out infection. If you do have an infection, the procedure will be abandoned and you will be rebooked with appropriate antibiotics beforehand.

If your procedure is being completed in theatres under local or general anaesthesia

• You will be invited to attend the theatres department.
• You may be asked not to eat and drink and not to take your medication. If you have any questions regarding this, please contact the department beforehand.
• On arrival to the department, the nursing team will ask you for a urine specimen. It is important that you do this in the department so it is fresh. The procedure will not be able to go ahead if we don’t have a sample to rule out a urine infection. If you do have an infection, the procedure will be abandoned and you will be rebooked with appropriate antibiotics beforehand.
• Wherever you have the procedure, you will be seen by the specialist nurse or doctor who will go through the plans of your procedure and ask you questions regarding your medications, allergies, previous Botox injection, and how you empty your bladder.
• Once you have answered the questions and had the opportunity to ask your own questions, you will be asked to sign a consent form which clearly states the potential risks and side effects of the procedure you are having.

What are the potential risks and side effects?

• Urinary tract infection (15%-20%) - see your GP if you have symptoms of burning/stinging when passing urine as you may require a course of antibiotics. We will give you oral antibiotics to go home with for 5 days.
• Blood in the urine (8%-20%) - this is usually minor and settles down without any treatment. If you however continue to bleed then you would need to seek medical advice and you may need a surgical procedure under general anaesthetic to stop the bleeding.
• Urinary retention (7-10%) – some patients will have difficulty emptying their bladder fully after Botox. This is helped by beginning intermittent self-catheterisation which is taught prior to the procedure, for as long as is needed. If you are unable to do self-catheterisation then you would be offered a suprapubic catheter (small permanent indwelling tube through the lower part of the ‘tummy’) to help drain the urine until the Botox wears off. We would not recommend having a permanent indwelling catheter going through the urethra for a long time due to the damage it causes to the soft tissues in the genitals.
• Bladder Pain (5%) – very occasionally, some patients develop a pain in the bladder following injections. This pain is usually controlled with simple painkillers such as paracetamol and typically resolves quickly following the injections. If this continues please attend your GP surgery.
• Generalised muscle weakness (less than 3%) – this is very rare. Some patients have reported weakness in muscles of the arms and the legs at other hospitals across the world. They have been reported to be mild and usually do not require a stay in hospital. The condition resolves with time although it can take several months. There is no specific treatment for this if it occurs.
• Allergic reaction – this is rare, however, get emergency medical help if you have any of these signs of an allergic reaction: hives, difficulty breathing, feeling like you might pass out, or swelling of your face, lips, tongue, or throat.
• Temporary ‘flu-like’ symptoms are experienced rarely – some patients who have had Botox have reported these symptoms for a week or two after the injections.

If you are happy to go ahead you will be asked to undress in privacy. You will be provided with a hospital gown to wear to cover yourself; this will avoid any water from the cystoscopy coming in contact with your clothes. If you wish to stay in your own clothing on the upper half of your body then please let the doctor or nurse know. If you wish to keep your socks on then please bring a spare pair with you in case they get wet. If you feel cold in the hospital gown, then please let one of the staff members know and they will help cover you with blankets.

In the urology department there is usually a specialist nurse or doctor and at least one other staff member in the room available to help you. There may also be visitors to the unit as we are a national and international training centre. Please let your doctor know if you do not wish to have any visitors in the room during your procedure. This is your right.

If the procedure is completed in theatres there will be a specialist nurse or doctor and a number of theatre staff to look after you and assist with the procedure. An anaesthetist will also be there if you have a general anaesthesia.

You will be asked to lie down on a couch. The specialist will then clean your genitalia with warm cleaning fluid and cover you with sterile drapes. This is important to protect you from infection after the procedure. A small amount of lubricating jelly is injected into the urethra, lubricating the area so you feel less discomfort. This may sting a little. A small telescope is then passed into your bladder. Your bladder is filled with salt-water (normal saline) through the telescope which may make you feel like you need to go to the toilet to pass urine. Sometimes there is leakage of water around the telescope but this is normal and the doctors and nurses expect it to happen. The nurse or doctor then passes a small needle down the telescope and injects between 10 and 20 injections of Botox into your bladder. The telescope and needle are then removed. You can then go and empty your bladder as normal.

The procedure may be uncomfortable but should not be painful. As the Botox is being injected, it can sting for a few seconds. If the procedure becomes uncomfortable you can ask the doctor or nurse to stop. The actual injection process may take about 10 to 15 minutes but expect to be in the department between one and two hours. In theatres however, you may expect to be there for some hours.

If this is your first time, you will receive a telephone follow up from one of our specialist nurses at around 6 weeks to check up on your progress. 

You may also be seen in the outpatient department 6-9 months after you have received your Botox if you request this. 

Following this, you will simply need to contact us once the Botox wears off to book your next session. 

You may also be approached regarding involvement in research and taking part in trials. If you are involved in a trial, your follow up plan may vary according to the trial protocol.

Your risk of getting an infection in hospital is approximately 8 in 100 (8%): this includes getting MRSA and Clostridium Difficile bowel infection. This figure is higher if you are in a ‘high-risk’ group of patients.

It is your responsibility to make sure that you are fit to drive after any surgical procedure. You only need to contact the DVLA if your ability to drive is likely to be affected for more than 3 months. If it is, you should check with your insurance company before driving again.

Thank you for taking the time to read this information sheet. 

Please make note of the link for your own records. You may be asked to sign a form saying you understand the information. 

If you do decide to proceed with the scheduled procedure, you will be asked to sign a separate consent form which will be filed in your hospital notes and you will, in addition, be provided with a copy of the form if you wish.

BAUS Botox leaflet 

Kuo HC, Liao CH, Chung SD. Adverse events of intravesical botulinum toxin a injections for idiopathic detrusor overactivity: Risk factors and influence on treatment outcome. Eur Urol. 2010;58:919–26 

Orasanu B, Mahajan ST. The use of botulinum toxin for the treatment of overactive bladder syndrome. Indian Journal of Urology : IJU : Journal of the Urological Society of India. 2013;29(1):2-11. doi:10.4103/0970- 1591.109975. 

Idiopathic overactive bladder syndrome: botulinum toxin A | Advice | NICE