Patient Information Sheet

Study on Knowledge of Pelvic Floor Problems

We would like to invite you to take part in a research study.

The study aims to investigate women’s knowledge of pelvic floor problems. The pelvic floor problems which we refer to include urinary incontinence (loss of urine or leaky bladder), pelvic organ prolapse (bulging downwards of the uterus into the vagina or outside the vagina) and faecal incontinence (leakage of stool/ faeces from the back passage).

If you agree to participate, we will ask you to complete the attached set of questions. This contains 24 questions with the answers “Agree”, “Disagree” or “Don’t Know”. At the end of the questions set, there are some additional background questions about yourself. The question set takes about 10 minutes to complete.

We are asking you to participate because you have never had a baby before and you are in your third trimester of pregnancy. We are looking for about 300 women at antenatal clinics in three different hospitals to complete the question set.

Your answers to the question set and your hospital number will be stored on computer for analysis. All information will be kept strictly confidential. Your name and address will not be stored on the computer with your answers. We may wish to contact you in a few years time to ask you to fill out another, similar question set. The results of this study may be published in a scientific journal. Nobody who takes part will be identified in this publication.

It is up to you to decide whether you would like to participate in the study. If you would like to take part, we will ask you to sign the consent form on the following page to show that you have agreed. If you decide at any future point that you would prefer your answers to the question set not to be included in our analysis, you are free to withdraw. This will not affect the standard of care that you receive. If you the person who approaches you with the question set is male and you would be more comfortable speaking with a female, please just let them know and we will arrange this for you.

Please let us know if you have any questions on this study. We will ensure that those are addressed to the Chief Investigator of the study, Mrs. Joanne Hockey.

If you have any concerns about the issues raised by the question set, your doctor in this clinic will be happy to discuss them further with you.

Finally, any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. Detailed information concerning this is given in Part 2 of this information sheet. Thank you.

Patient Information Sheet (Part 2)

Study on Knowledge of Pelvic Floor Problems

Every care will be taken in the course of this study. However, in the unlikely event that you are injured by taking part, compensation may be available. If you suspect that the injury is the result of the Sponsor’s (University College London) or the hospital's (The Royal Free Hampstead NHS Trust) negligence then you may be able to claim compensation. After discussing with your research doctor, please make the claim in writing to Mrs. Joanne Hockey who is the Chief Investigator for the research and is based at the Royal Free Hampstead NHS Trust. The Chief Investigator will then pass the claim to the Sponsor’s Insurers, via the Sponsor’s office. You may have to bear the costs of the legal action initially, and you should consult a lawyer about this.

Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated by members of staff or about any side effects (adverse events) you may have experienced due to your participation in the research, the normal National Health Service complaints mechanisms are available to you. Please ask your research doctor if you would like more information on this. Details can also be obtained from the Department of Health website:

Date:08/04/11

Version Number:2

REC Details: Oxford Research Ethics Committee C Reference Number: 11/SC/0080

Consent Form

Study on Knowledge of Pelvic Floor Problems

I confirm that I understand the information sheet dated 08/04/11 for the study, that I have had any questions answered satisfactorily and that I agree to take part in the study.
Name / Date / Signature

Date:08/04/11

Version Number:2

REC Details: Oxford Research Ethics Committee C Reference Number: 11/SC/0080

Question Set

Study on Knowledge of Pelvic Floor Problems

Date:08/04/11

Version Number:2

REC Details: Oxford Research Ethics Committee C Reference Number: 11/SC/0080

Below are some statements about urinary incontinence (loss of urine or leaky bladder).

Please state if you agree or disagree with each statement, or if you do not know.

1.Women are more likely than men to leak urine
 / Agree /  / Disagree /  / Don’t Know
2.Leakage of urine only occurs as you get older
 / Agree /  / Disagree /  / Don’t Know
3.Thin women are more likely to leak urine than overweight women
 / Agree /  / Disagree /  / Don’t Know
4.Being pregnant or giving birth may lead to urine leakage
 / Agree /  / Disagree /  / Don’t Know
5.Other than pads, not much can be done to treat leakage of urine
 / Agree /  / Disagree /  / Don’t Know
6.Certain exercises can be done to reduce development of urine leakage
 / Agree /  / Disagree /  / Don’t Know
7.Whether exercises are done before birth, or instead after birth, does not affect how well they work
 / Agree /  / Disagree /  / Don’t Know
8.If urine leakage happens related to pregnancy or birth, it is short-term in duration
 / Agree /  / Disagree /  / Don’t Know
9.Have you ever had a problem with urine leakage?
 / Yes /  / No

Below are some statements about pelvic organ prolapse (bulging downwards of the uterus into the vagina or outside the vagina).

Please state if you agree or disagree with each statement, or if you do not know.

1.Pelvic organ prolapse is more common in young women than in old
 / Agree /  / Disagree /  / Don’t Know
2.Heavy-lifting on a daily basis may lead to pelvic organ prolapse
 / Agree /  / Disagree /  / Don’t Know
3.Being pregnant or giving birth may lead to pelvic organ prolapse
 / Agree /  / Disagree /  / Don’t Know
4.Pelvic organ prolapse is more common in thin women than in overweight women
 / Agree /  / Disagree /  / Don’t Know
5.Once a person has pelvic organ prolapse, not much can be done to help
 / Agree /  / Disagree /  / Don’t Know
6.Surgery is one type of treatment for pelvic organ prolapse
 / Agree /  / Disagree /  / Don’t Know
7.A rubber ring called a pessary can be used to treat symptoms of prolapse
 / Agree /  / Disagree /  / Don’t Know
8.Have you ever had a problem with prolapse?
 / Yes /  / No

Below are some statements about faecal incontinence (leakage of stool/ faeces from the back passage).

Please state if you agree or disagree with each statement, or if you do not know.

1.Women are more likely than men to leak stool
 / Agree /  / Disagree /  / Don’t Know
2.Leakage of stool only occurs in older women
 / Agree /  / Disagree /  / Don’t Know
3.Being pregnant or giving birth may lead to stool leakage
 / Agree /  / Disagree /  / Don’t Know
4.If stool leakage happens related to pregnancy or birth, it is short-term in duration
 / Agree /  / Disagree /  / Don’t Know
5.Surgery is the only treatment for stool leakage
 / Agree /  / Disagree /  / Don’t Know
6.Have you ever had a problem with stool leakage?
 / Yes /  / No

Below are some background questions about yourself.

1.In what year were you born?
2.Is this your first child?
3.How many weeks pregnant are you?
4.How are you planning to deliver your baby?
 / Vaginal delivery /  / Caesarean section /  / Don’t know
5.Do you work in a medical field?
 / No /  / Yes / If yes, what do you do?
6.Have you ever consulted a urologist or urogynaecologist?
 / No /  / Once/ A few times /  / Often/ many times
7.What is your postcode?
8.We would like to understand your educational qualifications – please tick any that apply to you
 / GCSEs (or equivalent)[1] /  / A Levels (or equivalent)[2] /  / Diploma /  / Degree /  / None of these
9.For how many years have you lived in the UK?
10.What is your ethnicity?
White /  / British / Mixed /  / White and black Caribbean
 / Irish /  / White and black African
 / Any other white (please state which country) /  / White and Asian
 / Any other mixed background
Asian or Asian /  / Indian / Black or /  / Caribbean
British /  / Pakistani / Black British /  / African
 / Bangladeshi /  / Any other black background
 / Any other Asian background
Other Ethnic /  / Chinese
Groups /  / Any other ethnic group (please state which country)
11.From where have you found information on pregnancy and birth? (tick all that apply)
Family /  / Books / 
Friends /  / Television / 
Midwife /  / Internet / 
Doctor /  / School / 
NCT/ other antenatal classes /  / I haven’t needed any information sources / 
12.Of the sources ticked above, could you tell us the three most important sources for you:
1. The most important
2. The second most important (if you have listed a second)
3. The third most important (if you have listed a third)
1. ______
2. ______
3. ______

[1] GSCEs are school exams in England, typically taken aged 14 to 16

[2] A Levels are school exams in England, typically taken aged 17 to 18