Participating in the Registry

WHY HAVE I BEEN INCLUDED?

Your surgeon has identified you as having undergone or about to undergo surgery relating to stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). If you are unsure about your diagnosis, please speak with your treating clinician. You can view a patient information flyer by clicking here.

To find out if your treating hospital is contributing data to the APFPR, you can check by clicking here

Your specialist (or their staff) at the clinic or hospital will enter your information into the registry. Only relevant personal and health information will be collected. This includes:

your name and contact details so we can link your health and wellbeing feedback with your procedures for analysis;
details of your pelvic floor disorder including any related conditions;
the type of procedure including any device details if used or removed during surgery;
whether you experience, or have previously experienced surgery complications;
names of the hospital/s and doctors treating you.

If you wish to view what information (data items) we collect about you, please click here. Information is collected from your current health service as well as any other health service or contributing surgeon. To make sure all the essential information has been entered, your medical records may be reviewed. This information is recorded in a secure database.

If you wish to view the procedures, we currently capture data for, please click here.

This is an opt-out registry. This means that you need to tell us if you do not want to participate. If we do not hear from you, we may start collecting information about you. This may happen any time after two weeks from the date on your invitation letter.

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the registry at any stage and you can ask for your information to be deleted from the registry at any time. Please note however, if you choose to remove all your data from the registry, we will no longer have a record of you. This means that should you undergo additional SUI or POP related procedures in the future you may receive another invitation from the registry. For this reason, we prefer to keep a minimal amount of information to avoid recontact occurring. If you do NOT want your data to be entered onto the registry or would like to withdraw from the questionnaires component, you can opt out at any time by calling 1800 571 093 (toll free) or emailing apfpr@monash.edu and quote the office ID number on the letter.

Your decision whether to take part or not, will not affect your relationship with your treating hospital or specialist.

This registry will not have any immediate impact on the medical care you receive, however over time doctors will use the information from the registry to better understand what devices and procedures used in pelvic floor surgeries provide the best outcomes for future consumers.

Should you feel distressed or uncomfortable when answering the questionnaires, you do not need to continue answering the questions. At any time, you can choose to withdraw from the registry or you can withdraw from the questionnaires only.

PARTICIPATION

Your specialist (or their staff) at the clinic or hospital will enter your information into the registry. Only relevant personal and health information will be collected. This includes:

your name and contact details so we can link your health and wellbeing feedback with your procedures for analysis;
details of your pelvic floor disorder including any related conditions;
the type of procedure including any device details if used or removed during surgery;
whether you experience, or have previously experienced surgery complications;
names of the hospital/s and doctors treating you.

Information will be collected from your current health service as well as any other health service or contributing surgeon should you have further pelvic floor surgery in the future. To make sure all the essential information has been entered, your medical records may be reviewed. This information is recorded in a secure database.

If you wish to view what information (data items) we collect about you, please click here. Information is collected from your current health service as well as any other health service or contributing surgeon, should you have further pelvic floor surgery in the future. To make sure all the essential information has been entered, your medical records may be reviewed. This information is recorded in a secure database.

PATIENT REPORTED OUTCOME MEASURES In addition to the data mentioned above, to understand how patients asses their own outcomes associated with pelvic floor procedures, you will be invited to respond to three questionnaires. The registry will send you, via email or text message (SMS) a number of questionnaires. Questionnaires are administered before the surgery, and again 6, 12 and 24 months post-surgery, to evaluate your outcomes after the surgery has taken place. These questionnaires may be completed online, by mail, or by telephone with trained APFPR personnel. Questions are asked before and after surgery to determine surgery outcomes and distinguish between existing and new concerns. Data will only be accessed and provided to the registry once you have had an opportunity to choose whether to participate. The questionnaires we use are listed below, they ask you about your views on surgery outcomes such as urinary leakage, pain and discomfort.

APFPQ: The APFPQ consists of 42 questions across 4 clinical domains: bladder, bowel and sexual function, and pelvic organ prolapse.

EQ-5D-5L: The EQ-5D-5L measures health status through 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The respondent is asked to select the most appropriate statement in each of the 5 domains.

PGI-I: The PGI-I is a one-item rating scale which measures a patient’s change in clinical status either as a decline or improvement.

If you have any questions about this, or if you wish to opt out of these surveys, please contact us at apfpr@monash.edu

DO I HAVE TO TAKE PART?

Your decision whether to take part or not, will not affect your relationship with your treating hospital or specialist.

WHAT ARE THE RISK?

WHAT ARE THE BENEFITS OF PARTICIPATING?

Including your information in the APFPR will make an invaluable contribute to the future of Australia’s health system by helping to improve awareness about medical devices used in pelvic floor procedures, and facilitate safety monitoring. This project is designed to safeguard the health of people undergoing procedures involving stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

Information is collected in a simple and secure way, and provides peace of mind for participants that their procedure details are recorded. Details of your surgery including any device used, will be kept indefinitely on the registry, and can be accessed by yourself and your clinician should this information be needed in the future.

As more information is collected, the data produced will be analysed to inform new patients who are considering pelvic surgery with mesh to better understand the benefits and potential risks of these procedures. Aggregated outcomes from procedures involving devices over time will also be made available via public annual reports and to the Therapeutic Goods Administration.

WHY HAVE I BEEN INCLUDED?

PARTICIPATION

DO I HAVE TO TAKE PART?

WHAT ARE THE RISK?

WHAT ARE THE BENEFITS OF PARTICIPATING?

CORRP Privacy Statement