The Questions Which This Study Will Address
The aim of the trial is to determine whether the male sling is non-inferior to implantation of the AUS for men who have UI after prostate surgery , judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. In order to determine whether the male sling or AUS is cost-effective for the NHS in the UK, the interventions will be compared in terms of: incontinence in men after prostate surgery the relative harms of the interventions costs to the patients, and to the NHS, including the need for repeat surgery in both groups and overall patient satisfaction.
Principal objectives
What is the clinical effectiveness of implantation of the male sling compared with AUS in terms of self-reported incontinence at 12 months?
What is the cost-effectiveness of a policy of primary implantation of the male sling compared with AUS, measured by incremental cost per quality-adjusted life-year at 24 months?
Secondary objectives
What are the harms of each type of surgery?
What are the costs of the benefits and harms of each treatment policy?
Artificial Urinary Sphincter Is The Most Common Surgical Procedure Performed In Men Who Leak Urine After Prostate Cancer Treatment An Inflatable Cuff Is Placed Around The Urethra Through A Small Incision Under The Scrotum
It causes physical compression to limit urine leakage. Patients briefly squeeze a small control pump underneath the skin in the scrotum to deflate the cuff and urinate before the cuff automatically re-inflates. The fluid cycles between the cuff and a small reservoir placed through a small incision in the groin. AUS is appropriate for patients with moderate-to-severe stress incontinence in patients who have the manual dexterity to operate the control pump. The cuff can be deactivated by a Urologist if subsequent temporary catheter placement is needed but every attempt should be made to avoid future catheterization as this instrumentation could damage the cuff.
What Are The Risks And Complications Of The Male Sling Procedure
Complications are rare with the male sling procedure. However, if complications do occur, they can include:
- Inability to urinate This is the most common problem after surgery, and may require catheter reinsertion for another week or two. In very rare cases, a second surgical procedure may be needed to resolve this issue.
- Bleeding and infection This is a rare complication.
- ErosionThis is a rare complication.
- Recurrent leakage of urine
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Artificial Urinary Sphincter Risks
As with any surgical procedure, there are potential risks. The most significant is infection. Infection rates with implants are quite lowaround one percent. There are, however, certain conditions or events that do increase your risk of infection:
- spinal cord injury,
- diabetes ,
- chronic use of steroids such as prednisone, or
- undergoing a re-do surgery or in the setting of extensive scarring.
One of the great medical advances of artificial urinary sphincters is the use of a coating that holds in antibiotics to prevent bacteria from getting on the device. Our urologic surgeons use many meticulous techniques before and during surgery to minimize a patient’s risks of infection as much as possible.
What Happens After The Male Sling Procedure
Following your surgery, you may have a catheter exiting from the urethra for a short period of time. The catheter is in place to allow you to empty your bladder since there may be swelling after surgery that makes it difficult to urinate. After the swelling goes down, you will gradually be able to urinate on your own and empty your bladder well. However, your normal pattern of urination may not return for a few weeks. You can resume a normal diet after surgery.
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Verdict Of The Pros And Cons Of An Artificial Sphincter
The typical artificial sphincter is made from silicone rubber, and it is useful in the treatment of urinary incontinence. As with any medical device, there are some specific pros and cons to consider if your doctor thinks this option is the best way to treat your condition. Hospitalization is required to recover from the procedure, but most people can leave the day after having their device implanted.
Men and women can both receive this device, but it is much more common for males to have one because of how common prostate issues are during the aging process. About 90% of men who have incontinence after prostate removal experience a successful result.
Is Stress Urinary Incontinence A Side Effect Of Surgical Prostate Treatment
One of the most common side effects of radical prostatectomy is stress urinary incontinence.
It is expected for post radical prostatectomy SUI to be resolved within one year following surgery. In some cases, patients may continue to experience SUI without any improvement over time. If you are having issues with bladder control and is an issue six months after your procedure, you should see a specialized physician to seek medical advice and, if necessary, discuss your treatment options.
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What Is Urinary Incontinence
Urinary incontinence , sometimes referred to as lack of bladder control, is the involuntary loss of urine.
Patients suffering from UI are unable to control the release of urine from the bladder.
Urinary incontinence is estimated to affect 1 out of 10 males, with increasing prevalence associated with aging.
How Is The Aus Implanted
You will typically be asleep for this procedure. Spinal anaesthesia can also be used to block nerve response to pain.
Steps:
- The bladder is emptied. The surgeon will insert a catheter to make sure that your bladder is completely empty during surgery.
- Incisions are made. An incision is made between the scrotum and the anus to place the cuff around the urethra, and another one in the lower abdomen to insert the reservoir.
- The AUS is placed. The cuff is placed around the urethra. Finally, the pump is positioned in the scrotum without any other incision and is connected to the other two elements of the device.
The cuff is left open until the doctor activates it a few weeks later in the outpatient clinic.
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How Long Will It Take Me To Get Back To My Daily Activities
This depends on the procedure performed. The doctor may remove the catheter right after the procedure or a couple of days after surgery. You can usually leave the hospital two or three days after implantation of an artificial urinary sphincter. You may need to stay in the hospital longer if you cannot urinate or your bladder does not empty itself completely, or if you have problems in the wound area such as an infection. The recommended length of hospital stay varies in different countries.
After you leave the hospital, your body still needs time to fully recover from surgery. Because of this, the AUS will not be activated until your lower urinary tract has completely healed. This means that in the weeks after the procedure you will continue to have urine leakage. During this time you may also experience pain in the pelvic area, or feel pain when you urinate. Your doctor can prescribe medication to deal with these symptoms.
The doctor will schedule an appointment to activate the device 4-6 weeks after surgery. Your wound will be checked as well. Usually, stitches that dissolve and disappear are used.
During the recovery period your doctor may recommend to:
- Have a fever
Recovery From Bladder Leakage Surgery
Incontinence surgery recovery is quick, and my patients are typically able to resume daily activities within a couple of days.
Incontinence surgery recovery is quick, and my patients are typically able to resume daily activities within a couple of days. Sling patients are advised to avoid squatting movements for several weeks to allow for the sling to heal with sufficient compression of the urethra. Patients with an artificial urinary sphincter need to let the device, specifically the cuff, heal around the urethra before it can be used. This period is usually six weeks during which the incontinence is the same as before the operation. Patients return to the office six weeks after the surgery to have the sphincter activated and learn how to use it. Bladder control, or continence can be expected from this visit onwards. The satisfaction rates of both the male sling and the artificial urinary sphincter is very high: well over 90% of patients would undergo the respective surgery again.1, 2
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The Process And Parts
The system includes an inflatable cuff that’s placed where the bladder connects to the urethra. A balloon is inserted in the pelvic area to regulate the pressure that is placed on the cuff by the user. The pump that’s used to inflate or deflate the balloon to complete urination as needed is located in the scrotum. With some systems, the cuff refills automatically after urination to close off the urethra from the bladder again.
What You Need To Know:
Urinary sphincter replacement is surgery to replace your urinary sphincter with an artificial urinary sphincter . The urinary sphincter is a muscle that surrounds your urethra. The sphincter squeezes the urethra to keep urine in the bladder until it is time to urinate. An AUS device has a balloon reservoir, a cuff, and a pump. When the AUS is turned on, liquid inside the balloon flows into the cuff. When the cuff is filled, it squeezes your urethra to prevent urine from leaking out of your bladder. To urinate, you press the pump. This relaxes the cuff and allows urine to flow out of your bladder.
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What Are The Advantages Of The Male Sling Procedure
The male sling procedure is not a major surgery. One of the advantages is that the male sling procedure only requires a small incision in the perineum . Because of this small incision, the recovery time is fairly short. Most patients have their catheters stay in for one to three days depending on surgeon preference.
Evidence Explaining Why This Research Is Needed Now
The most recent Cochrane review showed that the efficacy of conservative treatment with PFMT was still unclear and the addition of other evidence did not change this conclusion. As a result, a large proportion of men are left with disabling incontinence which ruins their quality of life and many have no option but to continue with containment measures . Surgery is, therefore, currently the only option for active management of the problem. As such, the proposed trial will provide unique robust evidence, for patients, clinicians and healthcare policy-makers, on which to base treatment and healthcare provision decisions.
The number of men undergoing radical prostatectomy for localised prostate cancer is increasing . This trend may continue, as localised prostate cancer case-finding using PSA testing increases, potentially leading to more men subsequently requiring surgery for prostate-cancer-treatment-related urinary incontinence. As an indication, if 50 more men required an AUS each year, this would cost the NHS an additional £450,000. While treatment with the male sling appears to be less expensive, the harms, further treatment and revision surgery needs to be taken into account to determine full comparative cost-effectiveness.
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What To Expect After Surgery
The procedure typically requires an overnight hospital stay with a catheter that is removed the following day. There is a small incision in the groin area as well as an additional incision underneath the scrotum. There can be significant tenderness, bruising and swelling that dissipates over 2-3 weeks. The device is left deactivated initially after surgery. Therefore, it is expected that urine leakage will continue in the postoperative period until device activation around 6 weeks following surgery.
Incontinence Surgery And Recovery After The Incontinence Surgery Procedure
Incontinence, also known as bladder leakage, is a life-altering condition. Surgery to treat incontinence can likewise be life-changing. Before you decide to pursue incontinence surgery for male bladder leakage, youll want to understand the stress incontinence surgical procedures, the incontinence implants available, the SUI surgery recovery process and what it will be like to live with a male sling or artificial urinary sphincter device.
First of all, you should meet with your urologist for a focused physical exam and discussion about treatment goals. Depending on the severity of your incontinence and medical history one or more implantable device may be indicated for your stress incontinence surgery.
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Returning To Exercise And Activities:
Avoid exercises and activities that put pressure on your wounds for as long as your caregiver tells you to. These activities include riding bikes or horses. Talk with your caregiver before you start to exercise after your surgery. Ask your caregiver what exercises or activities are safe for you to do after surgery. Ask your caregiver when you can return to daily activities, such as work.
Artificial Urinary Sphincter Surgery
Performed with either general or spinal anesthesia, surgery to install the AUS system requires a few small incisions. One incision is made in lower part of the abdomen to insert the pressure-regulating balloon. Another incision is made in the area between the rectum and scrotum for the pump. AUS insertion is sometimes done as an outpatient procedure. A catheter is also inserted to allow for urine drainage immediately after AUS surgery. A urologist will remove it during a follow-up visit. It usually takes a few hours to complete the procedure.
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What Are The Types Of Incontinence
While Stress Urinary Incontinence is the most common type, there are different types of urinary incontinence.
Stress Urinary Incontinence
Stress urinary incontinence is the unexpected leakage of urine when an outside pressure occurs with activities such as heavy lifting, coughing, sneezing, laughing, or exercise.
This outside pressure causes the already weakened bladder to leak urine.
The bladder is held in place by the muscles and connective tissue in the pelvis. When these muscles are weak, the outside pressure can push the bladder downward, causing the urethra to open and the urine to leak out.
A weak or damaged sphincter may also be the cause of stress urinary incontinence.
Urge incontinence
Urge incontinence, or also referred to as overactive bladder , occurs when a person is unable to hold back the urine long enough until he gets to a bathroom.
Patients often complain that although they feel the need to void in advance but begin leaking before they can reach a bathroom.
In rare cases, urge incontinence may be an early sign of bladder cancer.
Overflow incontinence
Overflow incontinence is the result of a person being unable to empty their bladder completely due to an outlet obstruction such as an enlarged prostate and ultimately the overflow of the bladder with the newly produced urine.
With overflow incontinence, the bladder overfills and leaks out the excess urine, and the patient leaks urine continuously.
Functional incontinence
How Long Does An Artificial Urinary Sphincter Last
Artificial urinary sphincters usually last seven to 10 yearssome more than 20 years. However, your device will eventually need to be replaced. When an AUS fails, additional surgery will be needed to replace the device . The device may need to be replaced in a different location if your urethra thinned under the cuff over time.
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Risks Associated With Having An Aus
Although not common, the following problems can occur:
- Pain
- Long-term or permanent problems urinating
- You may have to insert a catheter into your bladder to drain your urine.
- You may also need to have another surgery to fix the problem.
How Does Is Work
A balloon reservoir that holds fluid sits within the pelvis and keeps a cuff inflated around the urethra, preventing leakage of urine. A pump placed in the labia in women and scrotum in men is then operated to deflate the cuff when you want to empty your bladder. The cuff automatically re-inflates after 3-5 minutes.
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Why Does Incontinence Occur After Prostate Cancer Surgery
There are two sphincter muscles that keep men continent before radical prostatectomy , the internal urethral sphincter and the external urethral sphincter. The internal sphincter is not under your control and is found at the bottom of the bladder, called the “bladder neck,” and in the prostate. This is removed during your surgery because the prostate cannot be taken out without removing this sphincter. You control your external sphincter, which is the muscle you can use to stop your urine stream and the one you can strengthen with pelvic floor muscle exercises. Normally, a healthy external sphincter is sufficient to provide continence. However, after RP, there can be some damage or dysfunction of the external sphincter, which can prevent you from recovering your bladder control. This may be due to damage to the nerves, blood supply, supporting structures, or the muscle itself as the external sphincter is located at the apex of the prostate gland.
Definition Of The Urinary Sphincter
The urinary sphincter is a muscle which clenches and allows you to hold your urine. When you choose, you voluntarily relax the muscle to begin urination. For some people, particularly those with stress incontinence or males after prostate surgery, this muscle weakens.These patients are candidates for artificial urinary sphincter placement.
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About Your Urinary Sphincter
Your urinary sphincter is a muscle that controls the flow of urine out of your bladder . When your urinary sphincter is contracted , it blocks the opening of your bladder so urine doesnt leak out.
Figure 1. Urinary sphincter
Normally, your urinary sphincter stays contracted until you choose to relax it to urinate . When you relax your urinary sphincter, urine leaves your bladder and flows through your urethra and out of your body .
Some people have trouble controlling their urinary sphincter. This causes them to leak urine. This can happen after surgery to remove the prostate or radiation therapy to the prostate.
You may need an artificial urinary sphincter if you lose control of your urinary sphincter.