Participant Information Sheet
Introductory Statement
The study, titled "The Effects of a Basic Pelvic Floor Muscle Strengthening Programme on Stress Urinary Incontinence in Active Females" is led by Dr. Aoife Burke, Principal Investigator from the School of Health and Human Performance at Dublin City University (DCU), with support from DCU Sports Science and Health undergraduate students Ms. Ciara Kavanagh and Ms. Hannah Nolan.
What is this research about?
This research aims to explore how a simple pelvic floor muscle strengthening programme can help reduce stress urinary incontinence (SUI) in active women aged 18 and older. The study seeks to identify the minimal amount of pelvic floor exercises needed to strengthen these muscles and reduce urinary leakage.
Why is this research being conducted?
SUI is a common condition in women, where involuntary urine leakage occurs during activities like exercise or coughing. It significantly impacts physical activity participation and overall quality of life. This study will help determine the least time-consuming yet effective pelvic floor exercises for improving SUI, making treatment more accessible to active women.
Why have you been invited to take part?
You have been invited to participate because you are an active woman aged 18 or older, possibly experiencing SUI. Your involvement will help identify effective pelvic floor exercises and contribute to better management of SUI in active women.
What will happen if you decide to take part in this research study?
If you participate, you will complete three questionnaires and perform a Pad Test, which measures urinary leakage during high-impact activities. You will be randomly assigned to one of three groups: a weekly exercise group, a 5 times per week exercise group, or a control group who will not need to complete any exercises, and will act as a comparison group. The total time commitment is approximately 1 hour per week for 8 weeks.
How will your data be used?
Data will be collected and processed in compliance with the GDPR. Personal information, including questionnaire responses, demographic data, and Pad Test results, will be used to assess the effectiveness of pelvic floor exercises. All downloaded data will be stored in a Google Drive Folder and accessed via secure devices that are password protected and accessible via multi-factor authentication for secure storage of data. Your data will be completely anonymous, as you will complete the survey using a unique ID code that is
determined by you. This anonymous data will be stored indefinitely for publication purposes and may be provided to external researchers if requested (e.g. meta-analysis or systematic review). The findings of this research study will be reported in a research article in a peer-reviewed journal, and at national/international conferences, but only grouped data will be reported. DCU will act as the Data Controller for this research project. This study will be conducted in compliance with the General Data Protection Regulation (GDPR), and
if you have any concerns regarding how your data in this study has been handles, you can contact: DCU Data Protection Officer, Mr. Martin Ward – (data.protection@dcu.ie Tel: 01-7005118) who will handle any data protection concerns arising from this research. An individual also has the right to report a complaint concerning the use of personal data to the Irish Data Protections Commission: htttps://www.dataprotection.ie
How will your privacy be protected?
Your data will be anonymized to protect your privacy. It will only be accessible to the research team and will not be shared with third parties. However, confidentiality can only be protected within the limits of the law, such as in cases of subpoena or mandatory reporting.
What are the benefits of taking part in this research study?
Participants in the intervention groups will benefit from a structured pelvic floor strengthening programme, which may reduce symptoms of SUI, improve physical comfort, and boost self-confidence. All participants will receive educational materials that can support long-term pelvic floor health. Even if participants are placed in the control group for the purpose of the study, they will be provided with educational materials and details of the exercise program upon completion of the study. The study also contributes to research that may improve
treatments for SUI in the future.
What are the risks of taking part in this study?
There may be mild discomfort or embarrassment during the Pad Test. Risks of muscular strain or injury from the exercises are minimal, and measures are in place to ensure safety, including supervision and first aid. Confidentiality will be maintained, and all data will be handled securely. Researchers understand that the pad test and details contained within the survey responses are of a sensitive nature and will be treated with the utmost of respect and confidentiality. If you become concerned either physically or emotionally about the findings of the pad test, you should contact your GP for further care and advice.
Can you change your mind at any stage and withdraw from this study?
Your participation is completely voluntary. You are free to withdraw from the research project up until the point of publication of the research findings. If you would like to withdraw from this research project, please contact Dr Aoife Burke whose details are at the bottom of this Participant Information Sheet. Changing your mind or not taking part in this research will not affect your relationship with DCU or the researchers named in this research project, and your withdrawal will be kept completely confidential. and you can withdraw at any time
without any consequences. If you choose to withdraw before your data is anonymized, you can request to have your data removed. After anonymization, it may not be possible to remove your data.
How will you find out what happens with this project?
Results will be shared through an undergraduate research thesis and potentially published in scientific journals. Participants who wish to receive the findings can provide their contact information to receive a summary at the end of the study.
Contact details for further information:
For more information, contact Dr. Aoife Burke (aoife.burke@dcu.ie), Ms. Ciara Kavanagh
(ciara.kavanagh89@mail.dcu.ie), or Ms. Hannah Nolan (hannah.nolan9@mail.dcu.ie). If you have concerns about the study, contact the Secretary of the DCU Research Ethics Committee at rec@dcu.ie or 01-7008000.
