Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Margaret Macaulay
m.macaulay@soton.ac.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Development of a new penile clamp to prevent urine leakage in men who have urinary incontinence following treatment for prostate cancer
Back

Development of a new penile clamp to prevent urine leakage in men who have urinary incontinence following treatment for prostate cancer

Not Recruiting

Open to: Male

Age: Adult

Southampton

Medical Conditions

Prevention of urine leakage in men who have urinary incontinence following treatment for prostate cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Treatment for prostate cancer can damage the bladder and urethra (the tube that urine passes through on its way from the bladder and through the penis) causing urinary incontinence (UI). Between 2 and 3 of every 20 men who have had surgery for prostate cancer have life-long UI requiring the daily use of incontinence products. Incontinence has a big effect on quality of life. It can leave men depressed and isolated, affecting personal relationships and resulting in stigma and limited social and professional opportunities. When treatment fails or is not appropriate, it is essential to control urine leakage. Men have a range of products available to them and often choose to use a mix of two or more products to meet changing needs. Most men use a pad at least some of the time, and a sheath or body-worn urinal for containing leakage over longer periods. The penile clamp (clamp) is a device that fits over the penis and is meant to squeeze the urethra closed, so that no urine can leak out. Men often find these clamps useful for short-term and/or vigorous activities e.g. dancing, swimming and going for long walks.
Previous research has shown that the available clamps do not perform well in terms of preventing leakage, being acceptable to the user and avoiding negative effects on skin health and blood flow in the penis. Therefore the researchers have concluded that there is a need for a better clamp. The new clamp will be developed by a research team at the University of Southampton, including engineers and healthcare professionals, working closely with men with UI following treatment for prostate cancer. Some of these men are experienced clamp users who assisted with the previous research testing clamps already on the market. This study aims to develop and test a prototype which, if successful, will be manufactured and sold.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

24 Jul 2018 31 Dec 2019

In the first part of the study, men who are experienced clamp users will visit the hospital and will wear each prototype clamp and an incontinence pad for 30 minutes and will be asked to do some exercises that can encourage urinary leakage. The pads will then be weighed to measure the amount of urine that has leaked out. The men will also fill in a questionnaire to assess their experience of using each clamp.
If one of the prototypes is effective at preventing urine leakage and is acceptable to the participants, it will be tested further to assess its effect on skin health, pressure and blood flow in the penis, inflammation, and damage to the urethra. The participants from the first part will be invited to come to a hospital laboratory for up to four 3-h sessions of testing. This will involve non-invasive tests using machines as well as taking urine samples.
If a prototype is acceptable in terms of skin health, blood flow inflammation and tissue damage, it will move into the user evaluation stage. Men who have not been previously involved in the study will be recruited and will test up to four clamps (including the prototype and a clamp that is on the market) by using them for up to 2 weeks. They will be told that they do not have to use the clamp if they find it uncomfortable and can take breaks from testing the clamp when they wish. They will fill in questionnaires on each clamp after each period of testing and will be asked which clamp they preferred once they have tested them all.


Men aged over 18 years who have UI following treatment for prostate cancer, including those who are experienced in using penile clamps and those who are not.

You can take part if:



You may not be able to take part if:


1. Absence of sensation to the penis (self-report)2. Absence of bladder sensation due to neurological impairment (self-report)3. Urge incontinence (a strong uncontrollable urge to pass urine and leakage before reaching the toilet) as the predominant urinary symptom (self-report)4. In the terminal stage of an illness5. Cognitive impairment (score of <27 on Mini Mental State Exam [MMSE] - to be carried out face-to-face by the research nurse)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southampton General Hospital
    Southampton University Hospitals NHS Trust Tremona Rd
    Southampton
    SO16 6YD

There is a small risk that circulation in the penis might be damaged if the clamp is fitted too tightly. The first time each is fitted, it will be done by a nurse with experience in fitting male devices. The clamp will be fitted at the loosest setting initially and tightened as necessary. The previous research conducted by the research team will inform the design of the prototype clamp and the design will seek to prevent problems caused by the clamp being too tight. In addition, the researchers will have applied the prototype clamp design to a computer model to estimate pressure applied on soft tissue before it is tried out on men.
Men who have reduced sensation in their penis, lack of awareness of bladder filling, urge incontinence as their main symptom or poor memory (which means they might forget to release the clamp regularly) will not be allowed to participate in the study. Many participants will have had experience of using clamps previously.
Skin reddening and grazing is possible from the mechanical action of the devices. The risk will be minimised by expert fitting of the devices by an experienced research nurse. Instructions will be given on how to identify potential skin problems and actions to take. Telephone support will be available for the men.
In the previous research study, one of the available clamps caused a small amount of bleeding from the urethra. The participant will be instructed to stop using a clamp if this occurs until bleeding has stopped. Once bleeding has stopped (and not sooner than 14 days later) he may restart testing the clamp or move onto the next one. He will be asked to inform the research nurse if this happens.
There is also a small risk of emotional distress when evaluating continence products, especially when associated with a diagnosis of cancer. The research nurses involved in the trial are all experienced in discussing incontinence with men and will ensure that all participants are aware of the risks and know how to identify and manage them. The participants will have telephone support from the research nurse who can make additional home visits if necessary.
As it is the research team's intention to develop an improved clamp, the prototype clamps may prove more effective and popular with the men than the clamps currently available. Participants may be disappointed that they are unable to keep the prototypes. The research team will minimise this risk by explaining carefully at the outset that the prototypes will have to be returned.
In everyday life, men purchase and use clamps with very little informed guidance. The men in this study will have regular contact with the research team and will have a much higher level of supervision than would be usual in clinical practice.
As for benefits, participants will receive reimbursement for travel expenses when attending Southampton General Hospital or other venues. They will be provided with refreshments as appropriate. Participants will have the opportunity to try out clamps that they might not otherwise come across. They will be able to contribute to the development of a new medical device.

Ms Margaret Macaulay
m.macaulay@soton.ac.uk



The study is sponsored by University of Southampton and funded by Prostate Cancer UK.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN45492194

Or CPMS: 32987

Last updated 01 April 2020

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top