Research Programme 4 – Trials and Large Scale Observational Studies
- OTIS Study
- MAPS Study
- CATHETER Study
- SUSPEND Study
OTIS study
(OTIS stands for Outcome after Transposed Intestinal Segment Surgery)
Why are we conducting this project?
Each year in the UK around 3,000 people have major surgery because their bladders are seriously diseased or must be removed. The most common reason is cancer in the bladder. Some surgical procedures are more complicated than others, but all involve using bowel segments to provide a system for storage and voiding of urine. The technically easiest way is to divert the urine either by using a segment of bowel to bring urine to a bag on the front of the abdomen, or by connecting the ureters (which normally carry urine from the kidneys to the bladder) to the large bowel. More complex ways are to use pieces of bowel to patch into the bladder or replace it altogether. There is no ideal procedure. Problems such as urine leakage, bowel disturbance, and sexual dysfunction are common, and these often have a profound effect on people’s lives. Increasingly, surgeons are tending to recommend the more complex operations in the hope that these will provide a higher quality of life. But it is not clear which operation is best for different types of patient.
Why is this research important?
The aim of this study is to find out which is the best type of surgery for different types of patient. The wider implications for patients and the NHS will be studied in a formal economic evaluation of cost-effectiveness. 640 patients will be recruited from 16 UK centres over 18 months with a minimum follow-up time for each patient of at least a year.
Funding organisation
The OTIS study is funded by BUPA Foundation.
When will this research take place?
The project is currently undergoing and has now closed for recruitment.
MAPS (Men After Prostate Surgery) study
Why are we conducting this project?
Many men experience some urinary incontinence after prostate surgery, but it usually improves with time. The chance of urinary incontinence is higher after radical surgery for cancer. The MAPS study aims to find out if physical treatment based on training the pelvic floor muscles can help men regain continence.
Why is this research important?
Current evidence suggests that physical treatment based on training the pelvic floor muscles can help men regain continence can, but it is not conclusive, and the training is time-consuming and resource-intensive.
How will this study be carried out?
Over a two-year period, around 17,000 men having prostate surgery in 26 UK hospitals will be approached three weeks after their surgery. Those who are experiencing urinary incontinence will be invited to join the study. 800 men (400 after radical and 400 after endoscopic surgery) who wish to take part will then be randomly allocated to treatment with a physiotherapist or continence nurse, or to a control group. The treatment aims to teach men to contract their pelvic floor muscles. Sometimes a monitor will be used so men recognise good muscle contractions (called biofeedback). Selected men will be taught how to lengthen the time between voids (bladder training). Men in the control group will receive usual care through their GP. We will find out not only if men’s continence has improved but also if their quality of life has changed with active treatment. In addition, we will assess whether any benefits justify the additional costs to the men and to the NHS.
The collaborators have the appropriate mix of expertise in management of prostate diseases, research on incontinence and in performance large multicentre cost-effectiveness trials. Aberdeen is the lead coordinating centre of this national multicentre study.
When will this research take place?
The project is currently undergoing and has now closed for recruitment.
Funding organisation
This project is funded by the NIHR HTA
Catheter Study
Reducing urine infections: a new study to examine the benefits of using antibiotic or antiseptic treated catheters
Why are we conducting this project?
About one in four patients in hospital need a urinary catheter for a short while. This may cause a urine infection in about 7% of them, amounting to about 30,000 patients over the course of a year in the UK. These infections are important because they slow the patient’s recovery from illness or surgery and can lead to serious consequences such as bloodstream infections. The NHS has a target to reduce such infections by 15%. This is hard to achieve however, as catheters easily become contaminated with bacteria from the patient’s own skin or bowel. For every day that the catheter is left in, bacteria colonise the urine in about 5% of patients. Simple measures such as general hygiene and removing catheters as soon as possible help to reduce the overall risk if developing a urine infection. Recently it has been shown that catheters containing antibiotics or antiseptics such as silver reduce colonisation by bacteria and lessen the risk of infection. These catheters are expensive, and it is not clear how much they benefit individual patients and whether the increased costs are matched by better health.
Why is this research important?
The results of this study will allow the NHS to decide whether, for short-term use, catheters containing antibiotics or antiseptics (rather than standard untreated catheters) will reduce infections, be cost-effective, and result in better patient health.
How will these studies be carried out?
The team will compare the use of standard catheters with those containing antibiotics or antiseptics in patients who only need a catheter for a short time (less than two weeks). Patients who need a catheter as part of their routine care will be randomly allocated to have either a standard or treated catheter. They will then be asked to fill in questionnaires in hospital, and after they go home, to find out whether a urine infection occurred, and if this affected their health, treatment, or hospital stay. The costs and benefits of each type of catheter can then be compared to see whether one is better than another for routine use in the NHS. We will also study patients who are especially vulnerable to severe infection, such as the elderly and those in intensive care, to see whether treated catheters might particularly benefit them.
When will this research take place?
The project is currently undergoing and has now closed for recruitment.
Funding organisation
Thanks to a grant of £1.4 million from the NHS research funding body Health Technology Assessment, the urology research team of the University of Aberdeen and NHS Grampian will lead a major, multi-centre trial involving several large hospitals which provide acute medical and surgical care, to investigate the benefits of using these ‘treated’ catheters.
SUSPEND (Spontaneous Urinary Stone Passage Enabled by Drugs)
Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre placebo controlled randomised trial of a calcium channel blocker (nifedipine) and an alpha-blocker (tamsulosin)
Why are we conducting this project?
Kidney stone disease is a common health problem affecting about 1.6 million adults in the UK. In some patients the stone will fall out of the kidney and become lodged in the tube (ureter) between the kidney and bladder. The majority of sufferers experience a sudden episode of prolonged abdominal pain, usually sufficiently severe to need emergency admission to hospital.
Stones are expelled by rhythmic tightening (contraction) and opening (relaxation) of the ureter which moves the stone downwards and out of the body. Stones may get stuck because the ureter downstream of the stone fails to relax to allow it through; suggesting that relaxant drugs may hasten stone passage. Recently two different relaxant drugs have undergone early testing for this purpose; tamsulosin (an alpha blocker) and nifedipine (a calcium channel blocker). These drugs are widely used for other health problems with a good safety profile and can be taken as once daily capsules. Preliminary results are encouraging with both drugs seeming to increase the chance of passing the stone by 50% and speed the process up by 4 days.
Why is this research important?
Given the pain experienced passing a ureteric stone and the high cost of having to remove them, any simple treatment that hastens or increases the chance of spontaneous stone passage would be welcomed by both patients and the NHS.
How will these studies be carried out?
The SUSPEND trial involves giving one of three alternative treatments; tamsulosin, nifedipine or dummy tablet (placebo) to 1200 people who have been diagnosed with ureteric stones and have agreed to take part in the trial. The main thing we will measure is whether the stone passes on its own or whether further intervention is required to remove the stone. Other things that we will be determining is how much pain each participant experiences and what affect this has on quality of life.
When will this research take place?
Recruitment will occur from November 2010 to 2012.
Funding organisation
This is a UK Collaborative Study funded by the NIHR HTA Programme
Please follow this link to the trial website:-
https://viis.abdn.ac.uk/HSRU/suspend/
Contact
For more information contact Kath Starr k.starr@abdn.ac.uk