Artificial urinary sphincter in women

What is the evidence base for this information?

This leaflet includes advice from consensus panels, the British Association of Urological Surgeons, the Department of Health and evidence based sources; it is, therefore, a reflection of best practice in the UK. It is intended to supplement any advice you may already have been given by your urologist or nurse specialist as well as the surgical team at Addenbrooke’s. Alternative treatments are outlined below and can be discussed in more detail with your urologist or specialist nurse.

What does the procedure involve?

The artificial urinary sphincter (AUS) consists of three components. One part is a circular cuff that is placed around the water pipe (urethra). This cuff is connected to a small pump that sits in the labia and also connected to small fluid-filled balloon that sits in the abdominal wall.

What are the alternatives to this procedure?

Incontinence into a pad, a catheter, urethral bulking agents, midurethral mesh or autologous sling, colposuspension, ileal conduit urinary diversion, bladder neck closure and Mitrofanoff catheterisable conduit.

What should I expect before the procedure?

You will usually be admitted on the same day as your surgery. You will normally undergo pre assessment on the day of your clinic or an appointment for pre assessment will be made from clinic, to assess your general fitness, to screen for the carriage of MRSA and to perform some baseline investigations. After admission, you will be seen by members of the medical team which may include the consultant, junior urology doctors and your named nurse.

You will be asked not to eat or drink for six hours before surgery and, immediately before the operation, you may be given a pre-medication by the anaesthetist which will make you dry-mouthed and pleasantly sleepy.

Please be sure to inform your urologist in advance of your surgery if you have any of the following:

• an artificial heart valve
• a coronary artery stent
• a heart pacemaker or defibrillator
• an artificial joint
• an artificial blood vessel graft
• a neurosurgical shunt
• any other implanted foreign body
• a prescription for Warfarin, Aspirin or Clopidogrel (Plavix®)
• a previous or current MRSA infection
• high risk of variant CJD (if you have received a corneal transplant, a neurosurgical dural transplant or previous injections of human derived growth hormone)

What happens during the procedure?

Normally, a full general anaesthetic will be used and you will be asleep throughout the procedure. In some patients, the anaesthetist may also use an epidural anaesthetic which improves or minimises pain post operatively.

You will have an incision in the lower part of your abdomen. This may a vertical incision or a Pfannenstiel (bikini line) incision. Your water pipe (urethra) is identified as it exits your bladder and the AUS cuff is placed around this. The pump is then placed into one of your labia and the balloon is placed into the abdominal wall.

What happens immediately after the procedure?

You will be given fluids to drink from an early stage after the operation and you will be encouraged to mobilise as soon as you are comfortable to prevent blood clots forming in your legs. You may wake with a urethral catheter and a pack in the vagina. The vaginal pack is usually removed within 24 to 48 hours. Sometimes, the catheter is left in place for a few weeks. You will be given intravenous antibiotics through your vein (intravenous). You will usually be discharged home two days after your surgery. You will also be given antibiotics to take home with you.

Are there any side effects?

Most procedures have a potential for side effects. You should be reassured that, although all these complications are well recognised, the majority of patients do not suffer any problems after a urological procedure.

Please use the check boxes to tick off individual items when you are happy that they have been discussed to your satisfaction:

Common (greater than one in 10)

• Blood in the urine , and temporary stinging when you urinate after the procedure
• Mechanical failure requiring removal and replacement of the implant
• Device infection requiring removal and replacement of the implant
• Vaginal or urethral erosion requiring removal and later possible replacement. Closure of erosion may leave a persistent fistula, which is an abnormal connection between the urethra and vagina. This fistula may lead to ongoing incontinence and may be difficult to close surgically

Occasional (between one in 10 and one in 50)

• Wound infection
• Temporary insertion of a bladder catheter
• Later failure of the device as the cuff becomes lose around the water pipe (urethral atrophy)
• Early device infection requiring prolonged antibiotics and sometimes device removal
• In the long term, infection of the device requiring removal
• Identified injury to the urethra or vagina which may require immediate surgical closure and abandonment of artificial urinary sphincter placement
• Persistent stress urinary incontinence
• Development of overactive bladder symptoms (urinary frequency and urgency)
• Permanent retention with a need to use a catheter to empty the bladder

Rare (less than one in 50)

• Pain from the device
• Inadvertent sphincter deactivation leading to incontinence (such as during cycling or sexual intercourse)
• Labia majora device erosion

Hospital-acquired infection (overall risk for Addenbrooke’s)

• Colonisation with MRSA (0.01%, two in 15,500)
• Clostridium difficile bowel infection (0.02%; three in 15,500)
• MRSA bloodstream infection (0.00%; 0 in 15,000)

(These rates may be greater in high risk patients eg with long term drainage tubes, after removal of the bladder for cancer, after previous infections, after prolonged hospitalisation or after multiple admissions).

What should I expect when I get home?

The device will be deactivated when you are discharged. You will be reviewed in clinic or on the ward at six to eight weeks post discharge when the device will be activated (by pressing a button on the pump within the labia).

What else should I look out for?

Following discharge, you should return to the hospital as an emergency if you feel unwell or develop redness or soreness around the wounds, if you notice abnormal or offensive vaginal discharge, or if you think any of the components of the AUS are visible.

Are there any other important points?

You will be reviewed in outpatients to see how you have got on. You will be asked to complete a questionnaire on your symptoms and results collected.

AUS implantation is widely practiced in men. Significantly less AUS implantation occurs in women due to perceived surgical difficulty and lower successful outcome. This is thought to be related to the fact that AUS implantation in women tend to have had multiple prior procedures for stress urinary incontinence.

All surgical complications and patient reported outcome measures will be collected to inform best practice.

Most implant complications occur in the first year.

Driving after surgery

It is your responsibility to ensure that you are fit to drive following your surgery. You do not normally need to notify the DVLA unless you have a medical condition that will last for longer than three months after your surgery and may affect your ability to drive. You should, however, check with your insurance company before returning to driving. Your doctors will be happy to provide you with advice on request.

Privacy and dignity

Same sex bays and bathrooms are offered in all wards except critical care and theatre recovery areas where the use of high tech equipment and/or specialist one to one care is required.

Hair removal before an operation

For most operations, you do not need to have the hair around the site of the operation removed. However, sometimes the healthcare team may need to remove hair to allow them to see or reach your skin. If the healthcare team consider it is important to remove the hair, they will do this by using an electric hair clipper, with a single-use disposable head, on the day of the surgery. Please do not shave the hair yourself, or use a razor for hair removal, as this can increase the risk of infection to the site of the operation. If you have any questions, please ask the healthcare team who will be happy to discuss this with you.

References

NICE clinical guideline No 74: Surgical site infection (October 2008); Department of Health: High Impact Intervention No 4: Care bundle to preventing surgical site infection (August 2007)

Is there any research being carried out in this field at CUH?

There is no specific research in this area at the moment but all operative procedures performed in the department are subject to rigorous audit at a monthly audit and clinical governance meeting.

Who should I contact for more help or information?

Oncology nurses

Uro-oncology nurse specialist
01223 586748

Bladder cancer nurse practitioner (haematuria, chemotherapy and BCG)
01223 274608

Prostate cancer nurse practitioner
01223 274608 or 01223 216897

Surgical care practitioner
01223 348590 or 01223 256157

Non-oncology nurses

Urology nurse practitioner (incontinence, urodynamics, catheter patients)
01223 274608 or 01223 586748

Urology nurse practitioner (stoma care)
01223 349800

Urology nurse practitioner (stone disease)
07860 781828

Patient advice and liaison service (PALS)

Telephone: 01223 216756
PatientLine: *801 (from patient bedside telephones only)
Email PALS
PALS, Box No 53, Addenbrooke's Hospital, Hills Road, Cambridge, CB2 2QQ

Chaplaincy and multi faith community

Telephone: 01223 217769
Email the chaplaincy
The Chaplaincy, Box No 105, Addenbrooke's Hospital, Hills Road, Cambridge, CB2 2QQ

MINICOM System ('type' system for the hard of hearing)

Telephone: 01223 217589

Access office (travel, parking and security information)

Telephone: 01223 596060

What should I do with this leaflet?

Thank you for taking the trouble to read this patient information leaflet. If you wish to sign it and retain a copy for your own records, please do so below.

If you would like a copy of this leaflet to be filed in your hospital records for future reference, please let your urologist or specialist nurse know. If you do, however, decide to proceed with the scheduled procedure, you will be asked to sign a separate consent form which will be filed in your hospital notes and you will, in addition, be provided with a copy of the form if you wish.

I have read this patient information leaflet and I accept the information it provides.

Signature……………………………….…………… Date…………….………………….