Urology Current Research

ACCTUATE is a randomised control trial, comparing the newly designed CymActive catheter, with a standard Foley type, over a period of three months. 

The Foley catheter was designed in the 1930’s, and is still in common use today, despite having several major side effects, including high levels of infection and impaired quality of life. The ACCTUATE study seeks to establish the acceptability of a newly designed catheter, the CymActive. The Cymactive catheter differs from the foley in design and use. It is entirely indwelling, and activated using a magnet, rather than having tubes protruding from the body, and is anchored in place with a mallecot anchoring system rather than the standard water filled balloon used by the foley, allowing complete bladder emptying. 

The primary aim of this study is to measure patients quality of life and pain, using patient questionnaires. The study will also monitor adverse events, and compare urine samples from the beginning and end of the study. 

For this study we are recruiting men with long term foley catheters, no previous lower urinary tract surgeries, with non-neurogenic urinary retention, of any age. 

Study Information:

Principle Investigator: Professor Hashim Hashim. 

Planned recruitment end date: October 2025

Local reference: 5516

Prospective, non-randomized, multicentre clinical evaluation of the recharge free Axonics SNM System (INS Model 4101)

Sacral Neuromodulation (SNM) is a recommended treatment for Overactive Bladder (OAB) including urinary urgency incontinence (UUI) and urinary frequency (UF), and fecal incontinence (FI). Long-term data support the safety, efficacy, and durability of the therapy. 

This study is a multi-centre non randomized, single arm trial, aiming to confirm that there are no new safety and performance outcomes for participants receiving the Axonics SNM System INS Model 4101 for the treatment of OAB and FI. 

INS Model 4101, also known as F15 is a non-rechargeable system, whereas previous Axonics neurostimulators use a rechargeable battery source that requires monthly recharging by the patient. The mechanism of action is identical to previous devices: therapy is delivered to the sacral nerve, typically the 3rd sacral nerve root. Model 4101 (F15) uses the same exact stimulation waveform as the previous Axonics models.

For this study, patients who are listed for SNM at Southmead, for OAB, will be offered the opportunity to participate, and followed up for a year after implantation, attending 3 monthly check ups and completing a series of questionnaires. 

Study information: 

Principle Investigator: Professor Hashim Hashim

Planned recruitment end date: July 2025

Local Reference: 5668

A comparison of diagnostic accuracy of Luminal Index and Standard of Care MRI for Accelerated detection of significant prostate cancer 

This study is trying to establish if a scanning method called Luminal Index MRI (LI-MRI) might be able to be as good as the Standard of Care MRI (SOC-MRI). 

A LI-MRI scan takes only 5-10 minutes compared to up to 45 minutes needed for a SOC-MRI scan and it does not require the injection of dye to improve images. 

Most people that enter the study will have had a PSA (Prostate Specific Antigen) blood test with a higher-than-normal reading.

Routinely, the next step would be to have a SOC-MRI scan of the prostate to investigate. 

Participants to the trial will have both types of MRI, the usual SOC-MRI plus the new LI-MRI in the same scan session.

The purpose of the MRI is to produce an image that your doctor examines to look for anything of concern that needs to be investigated further. 

If there is, the doctor would usually take samples of prostate tissue (biopsies) using a needle that would then be examined under a microscope to see if what was seen on the MRI image was cancer or caused by something else. 

Project Details

Principal Investigator: Mr Douglas Kopcke and Mr Stefanos Bolomytis (Co-PI)

Planned Recruitment End Date: Summer 2026

Local Ref: 5598

A radical prostatectomy (surgical treatment for prostate cancer) involves removal of the entire prostate gland and, in some cases, removal of the nearby pelvic lymph nodes.

 Even though both types of surgery take place in the UK, we do not know which one is better for men.  About 30% of men in the UK have some lymph nodes removed during their surgery for prostate cancer and the rest do not. Your surgeon will always use their expertise to decide what treatment is best for you. In this situation they are unsure whether it is best to leave the lymph nodes in or to take them out. 

The ELIPSE study will help us find out which is the best treatment for men who need to have prostate cancer surgery in future.  The ELIPSE study aims to answer the question, 'In men having surgery for prostate cancer, is removing lymph nodes better than not removing them?' 

Participants will be randomly allocated to one of two groups: prostatectomy alone or prostatectomy plus lymph node dissection, then followed up with questionnaires and medical records review.

Project Details:

Principal Investigator: Mr Anthony Koupparis

Planned Recruitment End Date: August 2026

Local Ref: 5212

MoonRISe-1 is a clinical research study of an investigational drug delivery system for adults with intermediate-risk non-muscle invasive bladder cancer.

The MoonRISe-1 study is evaluating an investigational drug delivery system called TAR-210.

Study doctors want to learn more about the effects of TAR-210 when it delivers controlled doses of an investigational medication (erdafitinib) into the bladder over approximately 12 weeks.

The TAR-210 is a small, flexible tube that is inserted into the bladder by a healthcare professional using a urinary catheter.

TAR-210 is not approved for use by any regulatory authority and can only be used in research studies such as this one.

Suitability for this trial includes testing your bladder tumour for specific genetic alterations called fibroblast growth factor receptor (FGFR) alterations.

FGFR alterations can be a factor in tumour growth and whether the cancer spreads.

FGFR testing needs to be performed on a urine and/or tumour tissue sample collected at screening.

If your tumour has the required FGFR alterations, you may be eligible to participate in the MoonRISe-1 study.

If you are eligible for this study, you will be randomly assigned to either :

Group A: The investigational drug delivery system (TAR-210) OR:

Standard of Care Chemotherapy (intravesical Mitomycin C)

Project Details:

Principal Investigator: Miss Helena Burden

Planned Recruitment End Date: Summer 2025 

Local Ref: 5531

Early stage prostate cancer can be managed by active surveillance, where patients are closely monitored. If the cancer reaches a certain stage (“progresses”) the patient can access curative treatment (such as surgery or radiotherapy). In the TAPS02 trial we are testing to see if we can slow down this chance of progression or maybe even stop it using short-term drug treatment.

The drug used is Apalutamide. It belongs to a group of drugs that work by blocking androgens (male hormones). By blocking the effect of androgens, apalutamide stops prostate cancer cells from growing and dividing. Doctors currently use apalutamide to treat men with non-metastatic castration-resistant prostate cancer (prostate cancer for which initial treatments have failed).

In the TAPS02 trial we are testing if short-term apalutamide might slow tumour growth and make it less likely for men on surveillance to progress and need treatment. Eligible participants are randomly selected to receive apalutamide or placebo and followed up accordingly with blood tests, health checks and imaging.

Project Details:

Principal Investigator: Mr Jonathan Aning

Planned Recruitment End Date: Spring 2026

Local Ref: 5543

Lower urinary tract infection with SARS COV2 infection.

It is increasingly recognised that non-respiratory problems can appear as damage in other organs/tissues due to COVID-19. Later on in the pandemic, small studies reported patients with SARS-CoV-2 infection develop new lower urinary tract symptoms (LUTS). More research is required to understand the short and long-term effects of COVID-19 on LUT function.

In the elderly, LUTS and incontinence are also associated with other health problems and are often the reason for needing residential or nursing home care. So, early detection of these patients and proactively treating symptoms, would have an enormous benefit. The objective is to conduct long-term studies in hospitalized patients who have received a diagnosis of COVID-19 compared with a control cohort with no history or current SARS-CoV-2 infection. The study uses validated questionnaires at baseline and after six months, to measure symptoms of LUTS.

Project Details

Principal Investigator: Nikki Cotterill

Planned End Date: 01/03/2023

Local Ref: 5052

Increasing physical activity levels using e-bikes to enhance prostate cancer survival – a randomised pilot study

Exercise has been identified as having numerous health benefits in cancer survivors, specifically among prostate cancer survivors, leading to improvements in quality of life and physical function.

The National Institute of Health Research in the UK and the European Association of Urology (EAU) now recommend that all men diagnosed with prostate cancer participate in supervised exercise training as part of standard treatment. However, delivering supervised exercise programs is rarely achievable in clinical care due to time constraints and training.

Exercise uptake amongst cancer survivors remains low throughout their cancer journey, therefore finding new and accessible ways to increase physical activity for this population is a priority. Electrically assisted bicycles (e-bikes) have been highlighted as a way to increase physical activity enough to achieve significant health outcomes, providing electrical assistance only when the rider is pedalling, through sensors which detect pedalling speed and force. There is also the added benefit of being more environmentally friendly than cars. This study aims to determine if we can recruit individuals to e-cycling from oncology clinics and if so, when in the treatment pathway is most appropriate to offer men an e-cycling intervention.

Project Details

Principal Investigator: Jonathan Aning 

Recruitment End Date: 30/09/22

Local Ref: 5166

A Retrospective study for prostate cancer diagnosis support

Prostate cancer is the most common cancer among men in the UK. It is estimated that 120,000 men go through diagnosis, 47,000 are diagnosed with prostate cancer, and 11,000 die from the disease each year. Magnetic resonance imaging (MRI) scans have recently been introduced to help reduce biopsy rates and improve detection of clinically significant cancer that requires treatment. The interpretation of prostate MRI scans needs proper training and experience.

Prostate cancer is being missed or found late, even with the new MRI pathway. Given the importance of the role of MRI in diagnosis, accurate reporting is crucial in the multidisciplinary management of prostate cancer. There is a growing interest in the potential to apply artificial intelligence (AI) computer software to improve and streamline the process.

Lucida Medical has developed AI software called Prostate Intelligence, Pi™, to support prostate cancer diagnosis. Preliminary results suggest that this prototype performs well compared to radiologists and alternative AI systems. This should help low-risk patients avoid unnecessary biopsies (and the related possible complications), and detect significant cancers with equal or better performance than world-leading hospitals. Consequently, it could reduce healthcare inequality, reduce the burden on the NHS, and give patients confident early diagnosis.

Project Details

Principal Investigator: Jonathan Aning

Recruitment End Date: September 2022

Local Ref: 5085

Virtual 3D modelling for improved surgical planning of robotic assisted partial nephrectomy

Surgery is the mainstay treatment for abdominal cancer, resulting in over 50,000 surgeries annually in the UK, with 10% of those being for kidney cancer. Preoperative surgery planning decisions are made by radiologists and surgeons upon viewing CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans.

The challenge is to mentally reconstruct the patient’s 3D anatomy from these 2D image slices, including tumour location and its relationship to nearby structures such as critical vessels. This process is time consuming and difficult, often resulting in human error and suboptimal decision-making.

Better surgical planning tools are essential to improve patient outcome and reduce the cost. To address this, dedicated software has transformed the 2D images into 3D images. The main research question to be addressed in the present study is, whether surgical planning using virtual 3D modelling (Innersight 3D) , improves the outcome and cost-effectiveness of surgery with many potential benefits for patients and surgeons.

The study will compare current surgical planning method to planning with the addition of virtual 3D models in randomised patient groups.

Project Details

Principal Investigator: Ahmed Mahrous

Recruitment End Date: December 2023

Local Ref: 5212

Outcomes in patients with high-risk prostate cancer who undergo radical prostatectomy (surgery which aims to remove the whole prostate, and the cancer cells inside it) as a primary therapy have not significantly improved with time. Early prostate cancer is highly responsive to hormonal blockade. Therefore, androgen (a steroid hormone) blockade prior to and after prostate surgery could decrease tumour burden, increase the likelihood of complete resection and improve objective outcomes such as metastasis-free survival (MFS – time without the cancer spreading) and overall survival (OS).

The purpose of this study is to determine whether 6 months of treatment with apalutamide (an antagonist of the androgen receptor), with or without abiraterone acetate and prednisone (AAP), and in combination with androgen deprivation therapy (ADT), improves the pathological complete response rate and MFS rates in patients with high risk localised prostate cancer that are indicated to undergo a radical prostatectomy, compared to patients receiving ADT and a placebo.

The study will consist of a screening period of up to 35 days, after which participants will be randomised (randomly selected) to receive either apalutamide (with or without AAP) and ADT or receive ADT and a placebo. Participants will then receive 6 months of treatment in 28 day treatment cycles, before undergoing a radical prostatectomy. They will then receive a further 6 months of treatment. Following the treatment phase, participants will enter a post treatment phase in which they will be followed up until death, the cancer spreads, they withdraw from the study or they are lost to follow-up.

Project Details
Principal Investigator: Mr Jonathan Aning
Planned End Date: 02/05/2023
Local Ref: 4398