TVT-O Informed Consent

PATIENT INFORMATION SHEET & CONSENT FORM

1. Study Title:

TVT-O Prospective Study.

2. Invitation paragraph

You are being invited to take part in a research study. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

Thank you for reading this.

3. What is the purpose of the study?

3.1 Background

Urinary Stress incontinence is a common condition which causes a significant impact on quality of life for many women. A large number of treatment options have been developed over the years and these different procedures involve various surgical approaches.

The Tension Free Vaginal Tape – Obturator (TVT-O) procedure is a sub urethral sling procedure.

The efficacy of the TVT and similar sling procedures has already been documented. This study aims to investigate the efficacy and safety outcomes in patients who have undergone a TVT procedure using the transobturator TVT-O device. This study aims to document potential safety and efficacy improvements offered by the new TVT-O device.

3.2 Purpose of the study

The purpose of this study is to determine the success and complication rate for the TVT-O Procedure in the treatment of urinary stress incontinence. In order to determine the incidence of any longterm complications the study will continue indefinitely. You will continue to be looked after by your doctor following the surgery but you will also be contacted independently by our research nurse and asked to complete an evaluation questionnaire.

The safety of the procedure will be determined by counting the number of problems that occur during the study, such as any pain or discomfort, mesh complications, infection or more serious problems that might need admission to hospital.

4. Why have I been chosen?

You were chosen to participate in the study, because your physician thinks that your urinary stress incontinence problem is suitable to be treated with a suburethral sling.

5. Do I have to take part?

It is up to you to decide whether or not to take part. If you do decide to take part, you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive. The study is only concerned with documenting your future health and success of the operation. The study does not change any aspect of your treatment.

6. What will happen to me if I take part?

6.1 General
If you decide to take part in the study you will be recruited to the study for future follow up. The research itself will last for several years as we are particularly interested in the long term outcomes of this procedure.

The TVT-O Device Is used to implant a tape in a suburethral position which aims to provide longterm relief from stress urinary leakage. At this stage the outcomes of suburethral slings have been documented for up to 5 years. We aim to make occasional contact with you and check your progress by postal questionnaire into the future.

6.2 Recruitment visit

Before you undergo the TVT-O procedure your doctor will go through your medical history with you. You will need to repeat urodynamic and MSU tests if you have not performed them in the last six months. These are routine examinations done to patients diagnosed with stress incontinence.

Additionally, your doctor needs to know:

· If you have any other urinary symptoms

· What past procedures or prescription drugs you have tried

· If you have any other diseases or illnesses

· What medications you are currently using

You will be asked to fill-in questionnaires and a bladder diary before your visit to the hospital for a period of 3 days. In the diary you will be asked to write down your symptoms (drinking and voiding habits) for 3 consecutive days. A pad test will enable your doctor to determine the quantity of urine loss each day. This will give your doctor a “baseline” record of your symptoms prior to treatment. This information will help you and the doctor to decide whether you are suitable to undergo the Midline IVS surgery.

6.3 TVT-O Surgery

The TVT-O procedure involves placement of a polypropylene tape under the midurethra using a special instrument. A small incision is made under the urethra and the instrument used to pass a plastic stylet around the urethra and through the obturator fossa. The tape is permanently incorporated into the tissues under the urethra and is usually unable to be detected by the patient.

Fig 1: The TVT-O is a polypropylene sling which supports the mid urethra. The tape is passed behind the inferior pubic ramus on each side from below.

The risks of the procedure are the usual risks of surgery which include pain, bleeding, infection, scarring, blood clots, pulmonary emboli and loss of function. Any pelvic surgery can potentially lead to bladder, bowel and sexual dysfunction. Patients who undergo a suburethral sling procedure have a risk of neourgency (a sudden compelling desire to void occurring for the first time after surgery) and voiding difficulty, both of which are usually temporary.

The polypropylene tape used in a TVT-O Procedure is a foreign body. The use of a foreign body such as a polypropylene mesh tape can be associated with erosion, infection or rejection of the prosthetic material. This study aims to determine the true incidence of these problems.

The technique involves passage of a needled instrument with a plastic tip from a vaginal incision to an exit point in the groin. Adequate visibility is provided by a vaginal incision which enables the TVT-O device to reach the pubic ramus from where it is rotated laterally to exit the skin in the inner thigh. The TVT-O is slid along the posterior surface of the pubic ramus where it is then able to exit the obturator foramen under direct visualization.

6.4 Post Operative Management

In the operating theatre you will be prescribed antibiotic medication in order to reduce the risk of infection after the surgery. You can go home the same day if you are feeling OK and you are passing urine without difficulty.

The TVT-O may cause temporary difficulty passing urine immediately after surgery so you will be watched closely by the nursing staff to ensure that you are emptying your bladder. An ultrasound may also be performed in the ward to ensure that your bladder is completely emptied.

6.5 Follow up visits

You will be asked to attend follow-up visits 1, 3, and 12 months after the surgery. Each visit will last approximately 20 minutes at your doctor’s clinic. During these visits, you will be asked to fill in some questionnaires to chart your progress. Additionally, you may discuss your symptoms with your doctor and decide whether any further investigation or management is necessary.

Once the study is over you will continue to be followed up by your doctor.

7. What do I have to do?

Once you and your doctor have decided that surgery is appropriate you will have the opportunity ask any questions and discuss your options. If you go ahead with surgery you will be given the option to withdraw either from the surgery or the study. If you decide to proceed with the study you will be asked to sign this consent form.

7.1 Lifestyle limitation

As with any surgery you should let your body heal. Right after the surgery you should “take it easy “and avoid lifting heavy things, stretching and avoid causing strain on the tape and abdominal stitches. You will be asked to follow a strict postoperative routine for the 7 days. This involves:

a. No house work.

b. No cooking – light meals only.

c. No exercising – no bending down or stretching up.

d. You may walk around the house but not out of doors.

e. No driving or riding in a car.

f. No douching.

g. No sexual intercourse.

h. No straining – YOU MUST NOT GET CONSTIPATED.

i. Empty your bladder frequently.

Once you have completed 1 week of severe restriction outlined above you will be allowed to return to normal activity but for 2-3 months you should avoid any strenuous exercise or activity.

7.2 Effect on Other Medical Conditions

A TVT-O procedure has no implications for any medical conditions other than pregnancy where choice of mode of delivery may be affected by the presence of a polypropylene suburethral tape. The tape becomes incorporated in the fibrous tissue of the pelvis and usually can not be identified at subsequent surgery.

7.3 Home or occupational environment

During the initial recovery phase you must limit your activities. Your regular day routine will be limited by the need to avoid any activity that could potentially move or damage the tape. This means that you will be discouraged from performing any domestic duties in the first two weeks after surgery.

8. What is the treatment that is being studied?

The TVT-O is a form of suburethral sling used to treat urinary incontinence.

9. What are the alternative therapies?

There are a large number of treatments available for stress incontinence. These include:

· Pelvic floor exercises

· Abdominal surgical procedures (Burch, Marshall Marchetti)

· Vaginal repair surgery

· Needle suspension procedures.

· Laparoscopic colposuspension procedures

· Other suburethral slings (TVT, IVS, SPARC, Monarc)

Your doctor will be happy to provide any information of these alternatives if you wish.

10. What are the side effects of any treatment received when taking part?

The potential side effects related to this study listed below are the usual side effects of incontinence surgery.

· Minor wound discomfort or pain

· Urinary tract infection

· skin irritation

· blood clotting

· anaesthetic complications (allergy or sensitivity to anaesthetic drug, breathing arrest, etc.)

· bladder perforation or damage during the procedure

· temporary difficulty passing urine after the procedure

· urinary urgency or urge incontinence

· development of vaginal prolapse

· possible sexual dysfunction

· reactions to the mesh used to make the TVT-O sling resulting in erosion, rejection or inflammation. .

In any case, whenever you feel an unusual or unexpected event or you experience less control of your symptoms or you becoming concerned, you should contact your doctor or nurse (detailed below).

11. What are the possible disadvantages and risks of taking part?

There are no additional risks associated with entering this study, but there are risks associated with undergoing surgery.

If you sustain any damage to you bladder during your surgery you will need a catheter for 24-48 hours to allow healing to occur.

If you have any problems passing urine after the operation you may need to use a catheter temporarily.

If you suffer a wound or urinary tract infection you may need antibiotic therapy.

Close attention will be paid to the development of any problems or complications which could be related to the placement of your TVT-O tape. Any new information regarding your medical condition will be recorded in the study files; however, your identity will remain confidential.

12. What are the possible benefits of taking part?

We do not believe that there is any specific benefit to you personally taking part in this research. However, there is a benefit to your symptoms as a result of undergoing the TVT-O procedure as results from past studies show that a suburethral sling is an effective cure for stress incontinence.

We hope that the treatment will help you, although this cannot be guaranteed. The information we get from this study may help us to provide better treatments for patients in the future.

13. What if new information becomes available

Sometimes during the course of a research project, new information becomes available about the treatment that is being studied. If this happens, your research doctor will tell you about it and discuss with you whether there are any implications for your care.

14. What happens when the research study stops?

At all times during and after the study you will be followed-up by your doctor.

15. What if something goes wrong?

Your right at law to claim compensation for injury where you can prove negligence is not affected by participation in this study.

16. Will my taking part in this study be kept confidential?

If you consent to take part in the research, any of your medical records may be inspected by team of doctors undertaking the research for purposes of analysing the results. They may also be looked at by the hospital administration, the ethics committee and from regulatory authorities to check that the study is being carried out correctly. Your name, however, will not be disclosed outside the hospital/GP clinic. Your own GP will be notified regarding your participation in this study.

17. What will happen to the results of the research study?

Results of this study may be presented at scientific meetings and published in journals. However, your identity will be held in strict confidence and not released to the public.

Results of the research will be published during the study and after it has finished. You will be able to receive copies of the publications from your research doctor upon request and from scientific medical literature. Your identity will remain strictly confidential in any such scientific publications.

If you are involved personally in any exposure to the media as a result of participating in this study you will be asked to sign a consent form to allow this. At all times your confidentiality and privacy will be maintained.

18. Who is organizing and funding this research?

This project is funded and monitored by

Centre for Pelvic Reconstructive Surgery

Suite 505, SAN CLINIC

Sydney Adventist Hospital

185 Fox Valley Rd

WAHROONGA 2076

Tel: +61 2 9473 8555

Fax: +61 2 9473 8559

Email: cprs@sanclinic.com.au

19. Who has reviewed the study?

The regulatory authorities in your hospital and medical ethics committee has reviewed and approved the clinical study.

20. Contact for further information

If you would like further information, please feel free to contact:

Dr Bruce Farnsworth	Robyn Tew RN
Suite 505, The SAN Clinic	CNS Sydney Adventist Hospital
Tel: 02 9473 8555	02 94879603
0416373772	0416234958

21. What are my rights as a Participant?

· No information regarding your medical history will be released other than information that is subject to legal requirements.

· No information regarding any tests or investigations will be released other than information that is subject to legal requirements.

· The details regarding your surgery will be explained to you including alternative therapies and possible side effects.

· It has been explained to you that your involvement in this research my not be of any benefit to you personally, but the purpose of this research is to improve the quality of medical care in the future.

· You have the right to have a family member or friend present while this project is explained to you.

· This study follows the guidelines of the National Statement on Ethical Conduct in Research involving Humans (1999).

· You will receive a copy of this document.

22. What if I have complaints?

If you would like to complain about the conduct of the research you may contact:

Medical Superintendent,

Sydney Adventist Hospital

Telephone 94879111

Centre Name and number:______________________________

Study Number: CPRS-05-1

Patient Identification Number for this study:__________________

CONSENT FORM

Title of Project: Safety and efficacy study for TVT-O procedure used to treat urinary stress incontinence

Name of Researcher:____________________________________

Please initial box

1. I confirm that I have read and understand the information sheet dated 1^st March 2005 for the above study and have had the opportunity to ask questions.	c
2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.	c
3. I understand the details of the TVT-O Procedure and associated risks, any discomfort involved and expected time of recovery. I also consent to attend follow up visits and complete postal questionnaires after the procedure.	c
4. I agree to take part in the above study and agree to the information collected being used in scientific evaluation of the TVT-O procedure.	c


Name of Patient	Signature	Date

Name of Person taking consent	Signature	Date

You will be given a copy of this information sheet and a copy of the signed consent form to keep.

Thank you for participating in the study.

1 copy for the patient; 1 for researcher; 1 to be kept with hospital notes