Urinary incontinence (UI) is common and debilitating, affecting over 6 million women in the UK, causing embarrassment, low self-esteem, social isolation, and reduced productivity. The first-line treatment is pelvic floor muscle training (PFMT), but currently one in three women still proceed to surgery.
Vaginal mechanical devices (VMDs), worn inside the vagina, support the bladder to help achieve continence. Guidelines recommend VMDs are used when PFMT is not effective. Combining VMDs with PFMT might be more effective for treating UI than PFMT alone, improving quality of life and reducing the need for surgery. VMDs are widely used, despite little evidence about their benefits, risks and whether they provide value-for-money.
Providing such evidence requires a complex and expensive clinical study. A preliminary study is needed to ensure that such study is feasible and can be conducted successfully.
We are recruiting women in the UK who are aged 18 years or over with clinically diagnosed stress predominant urinary incontinence, suitable for VCDs, willing to self-manage VCDs. and are able and willing to give informed consent to participate.
Please see ‘Where can I take part?’ to check if your local hospital is participating.
If you would like to know more about the FEEL-GOOD study, including information about taking part, please contact the FEEL-GOOD study office at the University of Aberdeen on 01224 438405 or 01224 438181 or email feelgoodstudy@abdn.ac.uk
If your local hospital is taking part in the FEEL-GOOD study, you may receive an invitation to take part in the study. Women will be given an information leaflet about the study – there is a link to download a copy of this below. Those who agree to take part will be asked to sign a consent form confirming that they would like to take part, and complete a questionnaire about their symptoms. Half of the women who take part will have pelvic floor muscle training and half will have pelvic floor muscle training and a vaginal continence device.
We will follow-up all the women who take part in the study after three and six months to find out how they are getting on.
Funding acknowledgement
The FEEL-GOOD study is funded by the Chief Scientist Office.
Participant Information
The University of Aberdeen is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen will keep identifiable information about you at least 6 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information here:
https://www.abdn.ac.uk/about/privacy/research-participants-938.php or by contacting the Data Protection office at dpa@abdn.ac.uk