What will participation involve?

Informed consent

You will need to review and sign an "Informed Consent Form," which provides a detailed description of the study, possible known risks and benefits of participation in the study, and what is expected of you as a participant.
Even after you have completed this form, you are free to discuss your study-related medical care with the investigator and site team. You may also stop participating in the study at any time without having to provide a reason.

Study visits

If you decide to take part in the Dignity study, you will be asked to visit the study physician for a study-related physical examination and a review of your medical history.
If you qualify for the study, you will need to go back to your study physician to receive medication for the first time (the medication under investigation or a placebo, which looks the same as the study medication but has no active effect), followed by periodic assessments.
12 weeks after the first time you receive the study medication, there is an opportunity for you to re-qualify to receive the study medication a second time. Everyone that qualifies the second time will receive the medication under investigation. No one will receive a placebo after the first time. Your study physician will assess if you are eligible for further treatment.
If you choose to withdraw early from the study, you are free to do so, but it will help the study team if you visit your study physician for one final check-up.

Bladder diary

You will need to record details about your bladder activity using the diary provided to you.
You will be given full training on how to complete the diary before you start the study.

Questionnaire

You will also need to complete various questionnaires about your health.
It is important that you, as the recipient of the study medication, answer questions regarding how you feel after receiving it. Your study physician needs to record any symptoms you experience, no matter how minor they may seem.

Review and confidentiality

The Dignity study is regulated by national and international laws to protect the welfare of all participants. At each Dignity study site, the design of the study and the way that it is run has already been assessed by an ethics committee who has checked that the study is conducted in accordance with the principles of Good Clinical Practice which ensure that you will be given appropriate medical care throughout the study.

The physician will not enter you into the study until you are clear about what is involved and have given your written consent to take part.

The study will involve collecting some personal information about you, but this will be limited to strictly relevant details and it will be stored securely so that no unauthorized person has access to it.