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Prostate Health: BHP, Cancer and Laparoscopic Prostatectomy

Friday, December 23, 2011 · Posted in , , , ,

While no one knows for certain what causes benign prostatic hyperplasia several million men are treated by physicians for it every year. There are no known risk factors and no known thing that can increase or decrease the chances of getting it. BHP is enlargement of the prostate gland, and is believed to be caused by aging. The number of men who suffer from BHP rises steadily along with the average male life expectancy. Symptoms of BHP include weak urine stream and frequent urination. Some men may experience visible swelling of the prostate area. In any case, a doctor should be consulted for the corrected treatment and to rule out more severe diseases, such as cancer.

Cancer of the prostate is a life threatening disease with requires treatment as well as prostate cancer surgery. While prostate cancer can be treated successfully it's treated easiest in it's early stages. As the name suggests, the cancer begins in the prostate glad. Though some studies have pointed to high fat or over production of testosterone intake as potential causes of prostate cancer, there is no definite data to prove these theories. Prostate cancer is the third most terminal cancer to men of any age, and like BHP, the chances of being diagnosed with cancer of the prostate increase with age. Farmers and men who have been exposed to certain chemicals such as cadmium are at a higher risk for developing prostate cancer.

Cancer of the prostate can be treated by laparoscopic prostatectomy. This new and innovative form of surgery is significantly less invasive than open surgery.

The Prostate Clinic, treatment and complete care for all the diseases and conditions which affect the prostate, urinary and reproductive system. Please visit our website at http://www.theprostateclinic.com/


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Benefits of Laparoscopic Prostatectomy Surgery

Sunday, December 18, 2011 · Posted in , , ,

Benign prostatic hyperplasia may or may not require surgery. When a doctor comes back to a patient with a diagnosis, a patient may ask what the diagnosis means and what he can do about it. The answer will not be prostate cancer surgery because the patient does not have cancer. The patient simply has an enlarged gland. Medical professionals will avoid recommending surgery unless it is absolutely necessary. A good doctor will seek for non-surgical procedures first.

Patients who come back with a different diagnosis may not fare so well. Doctors will prescribe chemotherapy, non-invasive procedures or prostate cancer surgery depending on how far the cancer has spread and the size of the tumor. He may recommend a laparoscopic prostatectomy. The patient may take some time to digest the news. No one ever wants to hear the first diagnosis, and the second suggestion often causes a person to experience a deeper level of shock.

The laparoscopic prostatectomy may sound scary but hundreds of men each year undergo the procedure. It does not necessarily require the entire removal of the prostate gland. The side effects remain the same for other types of treatment for prostate cancer. A man may become impotent, incontinent or suffer increased sexual desire after undergoing the surgery. All three may happen. Other side effects include prolonged pain.

The advantages of this type of surgery over the more traditional radical prostectomy is that it does not require removal of the entire glans. The goal is to remove the tumor. Additional advantages include a reduced amount of blood loss and an increased recovery time. The cancer recovery rites from either type of surgery are comparable. The survival rate with any type of cancer relies on early detection in the patient.

No one wants to hear his doctor says he has cancer. Even benign prostatic hyperplasia does not bode well for most men. Both conditions often start with increased urination, particularly during the night. Taking care of both problems will usually solve the first symptom. Malignant cells cause many more problems if they are left unchecked. Even if they are not left unchecked, the process of chemotherapy causes many problems.

If the patient can find little comfort in the situation, it is the fact that the surgery is unlikely to cause fatal complications. Doctors will understand a desire to seek a second opinion, but they may recommend not to take too long on getting the second opinion.

The Prostate Clinic, treatment and complete care for all the diseases and conditions which affect the prostate, urinary and reproductive system. Please visit our website at http://www.theprostateclinic.com/


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Managing The Catheter After Prostatectomy Part I: Expectations And Warning Signs

Tuesday, August 9, 2011 · Posted in ,

Men undergoing prostatectomy for prostate cancer face a recovery period that is somewhat different from other surgeries.  Unlike other surgeries, a radical prostatectomy requires a patient to wear a urinary catheter for 1-2 weeks after surgery.  This catheter is a narrow rubber hose that transports urine from the bladder, through the penis, and out to a bag outside of the body.  As you can imagine, this catheter takes some getting used to.  While most men do adjust well, others can have problems dealing with the catheter as well as complications associated with the device.  In this post, I will explain why a catheter is necessary after prostatectomy, what to expect when the catheter is in place, and common problems to look out for during this period.

Why is a Catheter Necessary?

In a previous post, I described the anatomy of the prostate and its relation to the bladder and urethra.  I think the best way to picture that layout is to imagine the bladder as an upside down fishbowl that pours urine through a donut (the prostate), and into a straw (the urethra within the penis).  During a prostatectomy, the prostate is removed and the bladder is directly connected to the urethra via stitches.  A catheter is passed through this connection (called the anastomosis) to allow it to heal without being disturbed by urine.  Generally, an anastomosis needs to keep dry to allow proper healing.  Otherwise, urine will leak through the anastomosis, creating a contracture (narrowing composed of scar tissue) which can impede the normal flow of urine out of the bladder. 

The amount of time the catheter spends in place depends on the type of prostatectomy performed.  For men undergoing open or traditional prostatectomy, the catheter time is usually 10-14 days.  In contrast, those men undergoing robotic prostatectomy usually only have to wear a catheter for 5-7 days.  This disparity has to do with the different ways the anastomosis is created in the two surgeries.  Robotic surgery tends to create an anastomosis that is usually more water tight and, so, heals a bit quicker.  As a result, the catheter does not need to stay in as long.

Common Complaints about the Catheter

1.      I feel like I am sitting on a ball:  One of the most frequent complaints I hear from men immediately after surgery is that they feel that they are sitting on a ball.  The reason for this feeling is often the part of the catheter located in the bladder.  The catheter is kept in place via an inflatable balloon which sits in the bladder.  After the catheter is placed, the balloon is inflated which prevents the catheter from sliding out the urethra.  This balloon is then deflated just prior to removal of the catheter.  Men often complain about feeling like they are sitting on a ball because they are actually sitting on one: the balloon of the catheter.  Fortunately, most men get adjusted to this feeling over time.

2.      I need to urinate:  Most men waking up from a prostatectomy will feel an overwhelming desire to urinate.  Even when they are told that they have a catheter in place draining their urine, they still feel like they have to urinate but cannot.  This uncomfortable feeling is also caused by the balloon in the bladder.  The bladder is used to nothing but urine within it at any time.  As a result, the presence of a foreign body in the bladder (the catheter/balloon) is highly irritating to the bladder.  To try to rid itself of the irritant, the bladder contracts.  Because the catheter is in place, this bladder contraction (called a bladder spasm) just pushes the urine located within the bladder out into the bag.  Because the balloon remains in place however, the bladder continues to try to expel it through repeated spasms.  In most men, this very bothersome desire to urinate goes away within a day or so.  For some men, however, the feeling persists.  Fortunately, there are pills available that can be given in the hospital and at home which relax the bladder, relieving the bladder spasms and the overwhelming desire to urinate.

3.      I have pain at the tip of my penis: This sensation is also caused by the bladder spasms described above.  Nerves travelling from the bladder to the tip of the penis are stimulated by the spasms and create pain impulses travelling down the shaft of the penis and to the tip.  Of course, the very presence of the catheter in the penis also leads to some discomfort.  Medicine for bladder spasms often decreases this pain in the penis as well.


4.      I have blood in the urine:  A small amount of blood in the urine can be normal.  After all, surgery can lead to bleeding and a prostatectomy is certainly no exception.  As a result, the urine can be light pink for a day or two after surgery.  In addition, a small amount of blood in the urine may be noticed after walking with the catheter in place.  This bleeding is caused by the balloon from the catheter rubbing on the bladder.  Nothing really needs to be done for this amount of blood in the urine.

In contrast, pure blood or clots coming out of the catheter and into the bag is a serious problem that requires immediate attention.  This is a sign of serious bleeding, usually outside of the bladder, that creeps in through gaps in the anastomosis.  Such bleeding can cause disruption of the anastomosis and actually break the bladder free from the urethra. In severe cases, such bleeding may require a return trip to the operating room to stop the bleeding and repair the anastomosis.  Often times, however, it only requires washing out the blood from the bladder by irrigating the bladder through the catheter with saline or sterile water.  In any case, significant blood in the urine is a red flag which deserves immediate attention from a physician.

5.      My catheter is not draining: This, too, can be a serious problem. While in place, a catheter is a life line for a man after prostatectomy.  It is the only conduit allowing urine to leave the body.  As a result, if the catheter malfunctions, there is no way for the urine to exit the bladder.  Sometimes, men identify a catheter malfunction when they notice that the bag into which the urine drains is empty for a prolonged period of time.  In other cases, however, a malfunctioning catheter can cause significant pain as trapped urine accumulates in the bladder and stretches it.

A malfunctioning catheter that does not drain urine is truly an emergency.  Allowing the bladder to distend too far can lead to a disruption of the anastomosis or even rupture of the bladder.  As a result, I always tell my patients that if the catheter does not work, they need to seek medical attention right away.  Because catheter malfunctions follow Murphy’s Law, they usually occur in the middle of the night, when the urologist’s office is closed.  As a result, a malfunctioning catheter often leads to a visit to the emergency room.  This is where it gets tricky.  As I mentioned before, the catheter is a life line after prostatectomy.  As such, it has to be treated with caution.  Removing the catheter prematurely or attempting to replace the catheter with another can create significant damage that may require a return to the operating room.  Such damage can cause a lifetime of incontinence.  That is why management of a malfunctioning catheter after a prostatectomy should ONLY be undertaken by an urologist.  An emergency room nurse or physician should NOT try to fix it, even if they have the best intentions.  I tell my patients to NEVER allow anyone other than an urologist to manipulate the catheter after a prostatectomy.  The stakes are just too high.

6.      I am draining urine around the catheter: Once in a while, after a prostatectomy, a patient calls me to tell me that urine is draining out of his penis around the catheter.  This problem is caused by one of two problems.  In some men, bladder spasms can be so severe that urine is expelled both through and around the catheter.  In other men, a malfunctioning catheter can distend the bladder to the point that trapped urine escapes around rather than through the catheter.  These two scenarios can often be distinguished by whether or not some urine is draining through the catheter and into the bag.  Bladder spasms will usually cause urine to drain both through and around the catheter.  A malfunctioning catheter, in contrast, will not allow drainage into the bag so urine will only be seen leaking out of the penis.  Regardless, drainage of urine around the penis should be expeditiously addressed by an urologist.

Take Home Message

The urinary catheter can make recovering from a prostatectomy a difficult endeavor.  For those men who never had to wear a catheter previously, the experience can be quite scary and foreign.  However, understanding what to expect can prevent a great deal of unnecessary anxiety.  Similarly, knowing what red flags to look for can prevent significant discomfort and complications.  In my next post, I will cover the next step in the catheter saga: what to expect when the catheter is removed.


 

   


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Managing Urinary Incontinence After Prostatectomy Part II: When Conservative Measures Fail

Sunday, June 26, 2011 · Posted in ,

In my last post, I stressed the point that most men will regain continence within 12-18 months after prostatectomy.  I emphasized that although men undergoing prostatectomy should be proactive about pelvic floor muscle exercises to regain their continence more quickly, they should also remain patient because the vast majority of men do reach almost complete if not total dryness after prostatectomy.  For some men, however, this relief from urinary incontinence never comes.  Ten to fifteen percent of men remain significantly wet even years after surgery.   For some of these men, this incontinence requires changing diapers several times per day which ruins their quality of life, destroys their self esteem, and limits their ability to take part in beloved pastimes and activities.  For these men, more aggressive options are available to limit the leakage of urine.  In this post I review the invasive, surgical treatments of urinary incontinence.  I, again, stress that these options should be reserved for intractable incontinence that persists 12-18 months post prostatectomy and beyond.

Urethral Bulking Agents

The least invasive surgical option for refractory incontinence after prostatectomy is the injection of urethral bulking agents.  Such a procedure is performed using a camera to visualize the inside of the urethra and, specifically, the area of the urinary sphincter.  Once this muscle is visualized, a bulking agent (gluteraldehyde crosslinked collagen) is injected endoscopically (through the camera) into the lining of the sphincter.  The idea behind this treatment is to “bulk up” the sphincter, increasing the resistance to urine travelling from the bladder.  Early studies on the use of urethral bulking agents after prostatectomy were encouraging.  One study reported that 58% of men with incontinence who underwent the procedure had either good or at least improved results at a follow up of 10.3 months.  More recent studies were not so positive, however, with reports of complete dryness of 8-17% and social dryness (no more than 1 pad per day) of 38% after multiple injections.  A recent study of over 300 men treated with injectable bulking agents reported that men undergoing the procedure still required an average of up to 3 pads per day.  The same study reported that the therapy was only effective for an average of 6 months, after which another injection was required.  Due to these suboptimal results, bulking agents are generally NOT recommended for men with incontinence after prostatectomy.

Male Slings

A more invasive surgical option for men with incontinence after prostatectomy is the male sling.  While numerous types of slings are commercially available, they all share a common mechanism of action: compression of the urethra.  As with the bulking agents, the idea is to compress the urethra so as to increase the resistance to urine leaking from the bladder.  Unlike the direct injection of agents into the sphincter, however, slings are secured underneath the urethra.  Created as an artificial polyester mesh, the sling is like a hammock which sits under the urethra to serve as a backstop and provide gentle pressure to restrict urinary leakage.

Various versions of male slings date back to the late 1990s.  The first male slings were fashioned after slings used for female incontinence during the same time period.  The hammock portion of the sling was connected to sutures (strings) that were pulled out above the muscles of the anterior wall of the abdomen (the muscles referred to as a “six pack” in those of us who work out).  The sutures would then be tied above these muscles(but below the skin) to secure the sling in place.  The whole procedure could be carried out through a small incision underneath the scrotum and another, even smaller, incision just over the bladder.  A study evaluating men undergoing this early version of male slings reported complete dryness in 56% and satisfaction in 90% of men undergoing the procedure.

This early version of the male sling was refined in 2001 with the development of the bone-anchored sling.  This new variant avoided passing sutures through the abdomen (and the associated risk of damaging the bladder and intestines) in order to secure the sling.   Instead, this new sling was secured in place under the urethra via sutures that were actually anchored into the pelvic bones adjacent to the urethra.  Success rates reported with the bone anchored sling have been variable, ranging from 37-87%, depending on the definition of complete continence. 

      


 Diagram of a Bone Anchored Sling


More recently, yet another version of the male sling has been developed.  This version is called the Transobturator (or AdVance) Sling.  The sling, also placed under the urethra for compression, is secured by passing it through a canal within the pelvic bones.  As such, the synthetic material is passed through an incision underneath the scrotum and out of another incision in the inner thigh (just underneath the groin crease).  The sling is then cut at the skin surface of the incision in the thigh so it is not visible after surgery.  The results of this technique mirror those of the bone anchored sling.  The transobturator sling and bone anchored sling
are currently the two most commonly used slings for incontinence after prostatectomy.



                                       Diagram of a Transobturator Sling

Like any other surgery, implantation of the male sling can result in complications.  Urinary retention can sometimes be experienced (3%) if the sling is made to tight, requiring a subsequent surgery to loosen or remove it.  Because the sling is a foreign object within the body it can become infected (6%) or can actually erode into the urethra (2%).  Either of these complications requires a repeat operation with complete removal of the sling.

Artificial Urinary Sphincter

Although more invasive then urethral bulking agents or male slings, the artificial
urinary sphincter (AUS) remains the gold standard for men with persistent incontinence after prostatectomy.  The AUS is composed of three interconnected parts.  The main part of the device is comprised of an inflatable cuff which is wrapped around the urethra (in the same location as where the male sling is usually placed).  The cuff is connected to a reservoir (containing fluid) that is implanted in the abdomen and a pump that is implanted in the scrotum.  At baseline, the cuff encircling the urethra is inflated with fluid.  As such, the cuff compresses the urethra, preventing leakage of urine from the bladder.  However, when the patient pushes on the pump within the scrotum (which can be manipulated through the skin), fluid from the cuff is transferred to the reservoir.  When all of the fluid is transferred from the cuff to the reservoir, the cuff is deflated and no longer compresses the urethra.  This allows urine to flow from the bladder and out of the penis. The fluid in the reservoir drains back into the cuff after a fixed period of time, inflating it and allowing it to compress the urethra again.  The whole process is carried out via hydraulics. 







Diagram of Artificial Urinary Sphincter


The advantage of the AUS is that it replicates normal continence.  Men with the AUS remain dry until they want to void at which time they activate the device, allowing the urine to drain for a set period of time.  Success rates with the AUS have been notable.  Initial studies reported complete dryness ranging from 79-100% with one study finding a decrease in pad usage from 2.7 to 1 per day.  More recent studies have demonstrated social continence (up to 1 pad per day) of 58-88%.  There are some drawbacks, however.  First, any man that wants an AUS needs some level of manual dexterity that will allow him to operate the pump in the scrotum.  In addition, as with all machines, the device can and does break down (6% rate over 5 years), requiring the parts to be removed or replaced through further surgery.  Other complications associated with an AUS include infection (5.5%) and erosion into the urethra (6%).  As with the male sling, either of these two complications requires removal of the device.  Another potential complication is  recurrent incontinence.  This complication usually occurs due to urethral atrophy, which prevents the cuff from successfully compressing the urethra.  In this situation, a repeat procedure is performed in which a second (tandem) cuff is added to provide additional compression of the urethra.

Take Home Message

While most men will eventually regain continence after prostatectomy, some will continue to have moderate to severe, debilitating leakage.  Fortunately, men with this complication still have hope in the form of surgical techniques.  While minimally invasive and creating the least risk, urethral bulking agents are not very effective and generally not recommended for the treatment of incontinence after prostatectomy.  Male slings, although somewhat more invasive have been demonstrated to have significant efficacy and are being used more and more commonly for mild to moderate incontinence.  The gold standard, however, remains the artificial urinary sphincter.  Although not a panacea and definitely plagued by its own risks and complications, the AUS has provided reliable dryness for men with moderate to severe incontinence after prostatectomy.  Regardless of the technique chosen, the decision to proceed with surgical management should be considered carefully after thoroughly weighing the risks and benefits with a qualified urologist.  This decision should not even be considered until at least a year after surgery.


 

   



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Managing Urinary Incontinence After Prostatectomy Part I: Be Proactive But Patient

Sunday, June 19, 2011 · Posted in ,

One of the more notorious complications of radical prostatectomy is urinary incontinence.  Ranging from a few drops to complete lack of control, leakage of urine after prostatectomy can be a debilitating side effect that has a dramatic impact on quality of life.  Reading numerous posts from men on various prostate cancer forums, I got the impression that many men feel that urinary leakage after prostatectomy is inevitable, permanent, and devastating.  In reality, the presence, extent, and timing of urinary incontinence is highly variable and, to a significant extent, can be successfully managed.  In this post I will explain who should expect to have urinary incontinence after prostatectomy, how long such leakage usually lasts, and how to prevent and treat it. 

Who Experiences Urinary Incontinence After Prostatectomy?

The reported rates of urinary incontinence after radical prostatectomy are variable at best.  Studies have reported rates of urinary incontinence between 3 and 74%.   One reason for this tremendous disparity is the definition of “dry.”   While some studies categorized men as dry if they did not use any pads after prostatectomy, others were more lenient, designating men that use 1-2 pads per day as dry as well.  Other studies did not even rely on pad usage and simply asked men whether they subjectively felt wet or dry. 

In truth, immediately after surgery, most men will leak urine.  When the catheter is removed, the majority of men will require pads or diapers, if even for a short period of time.  The reason for this initial leakage has to do with damage to the urinary sphincter, the main mechanism for controlling urination.  During prostatectomy, this muscle complex, which is located near the tip of the prostate, is damaged to varying degrees.  As a result, when the catheter is removed soon after surgery, the debilitated sphincter is often not strong enough to control the flow of urine from the bladder, particularly during times of increased abdominal pressure while coughing, straining, or lifting heavy objects. 

While most men will leak immediately after a prostatectomy, studies have demonstrated that some men are more prone to significant incontinence than others.  Older men, for example, are more likely to leak, presumably due to less muscle mass in their sphincters as compared to those of younger men.  In addition, overweight men are more likely to suffer from incontinence.   As I mentioned in my post about obesity and prostate cancer   (http://prostatecancersymptomstips.blogspot.com/2011/04/prostate-cancer-and-obesity-deadly.html), overweight men pose a technical challenge during surgery, making damage to the sphincter and subsequent leakage more likely.  Similarly, men with larger prostates and those with more aggressive cancers have been shown to develop urinary incontinence more frequently, also due to the fact that their more challenging anatomy can increase the risk of damaging the sphincter during surgery.  Of course, while such risk factors may increase the risk of incontinence after surgery, they by no means guarantee it.

Despite the tremendous variation as to the incidence of incontinence reported after prostatectomy, there appears to be a consensus about its resolution.  Fortunately, the majority of studies demonstrate that most men eventually regain control of urination after surgery.  These studies report a progressive return of continence over time with 51-71% of men regaining urinary control after 3 months, 70-87% enjoying continence after 6 months and 80-92% reporting dryness at 1 year.  While this data does not provide solace for the minority of men that don’t reach continence, it does provide evidence that incontinence after prostatectomy needs to be approached with patience.

Managing Incontinence After Prostatectomy

Although most men will regain continence after prostatectomy, a proactive approach can significantly decrease the time to reach this sought after dryness.  The best way to ensure a quicker path to continence is to strengthen the sphincter.  Like any muscle in the body, the sphincter becomes stronger and more efficient if it is exercised.  In a sense, men need to take their sphincters to the gym.  The main exercises developed to “work out” the sphincter are the Pelvic Floor Muscle Exercises (PFME).  These types of exercises are better known to women as “Kegels.”  These exercises are performed by trying to stop urinary flow once it has begun.  Once men identify the muscles needed to accomplish this task, they can then perform the exercises even when they are not urinating. 

Some men find it difficult to identify the exact muscles they need to exercise.  For these men, biofeedback therapy may be appropriate.  This therapy involves placing a probe in the rectum, which can measure the force with which the sphincter is contracted during PFME.  Through such a device, a therapist can provide feedback to the patient as to whether they are contracting the right muscles.   After such biofeedback, patients can be more confident that they are performing the PFME correctly.  However, studies have not demonstrated significant differences in continence between men undergoing biofeedback versus those treated with PFME alone.

The more PFME that can be performed on a daily basis, the better.  Urologists generally recommend a hundred or more a day.  Studies have demonstrated significant decreases in the time to continence in men performing such exercises after surgery.  In fact, randomized studies demonstrated that 74-88% of men regularly performing PFME were dry 3 months after prostatectomy as opposed to only 30-56% of men who did not perform the exercises.  Interestingly, these same studies did not demonstrate a significant difference in continence between the two groups at 1 year after surgery, signifying that while PFME can decrease the time to continence, most (although certainly not all) men will achieve dryness by 12-18 months after surgery, regardless.

Preventing Incontinence Before it Starts

While PFME performed after prostatectomy have been demonstrated to decrease the time to continence, this benefit is even more dramatic for those men that start to perform the exercises prior to surgery.  A randomized study of 118 men undergoing radical prostatectomy, for example, compared continence rates at 1 and 3 months after surgery for those men starting PFME 1 month prior to surgery versus those starting these exercises postoperatively.  The study demonstrated that men starting PFME prior to surgery were only 40% as likely to have incontinence at 1 and 3 months after surgery as compared to those men that did not start the PFME until after prostatectomy. 

Another way to prevent or at least limit incontinence after prostatectomy is through nerve sparing prostatectomy.  Investigators have suggested that the nerves around the prostate may not only provide nerve impulses to the penis (to stimulate erections) but also to the sphincter.  As a result, sparing these nerves during surgery may better preserve nerve signals to the sphincter and maintain its function after surgery.  Such a theory was supported by a study which demonstrated that men undergoing nerve sparing surgery recovered their urinary control twice as quickly (5.3 versus 10.9 months, respectively) as those men who did not have their nerves spared during the procedure.  Of course, the decision to perform nerve sparing is not simple in men with high risk disease for whom the benefits of nerve sparing must be weighed against the potential for positive margins and recurrent cancer.

Take Home Message

Urinary incontinence is a common side effect of radical prostatectomy.  While almost all men suffer from some degree of leakage of urine immediately after surgery, most regain their continence within 12-18 months.  Men with risk factors for incontinence such as advanced age, obesity, high risk disease, and large prostates, need to be aware before surgery that they may be challenged by more severe incontinence for longer periods of time.  All men planning to undergo prostatectomy should learn PFME and begin such exercises prior to surgery.  In addition, when safe and possible, nerve sparing surgery should be performed.  Through such precautions, most men will be able to regain the ability to control their urination more quickly and effectively.  Despite all of these efforts, however, some men have debilitating, persistent incontinence.  After failure of conservative management for 12-18 months (and sometimes longer), appropriately qualified men need to be offered more aggressive, surgical management of their incontinence.  I will cover these options in my next post.


 

   

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Shortening Of The Penis After Prostatectomy: Yes, It Really Happens

Saturday, June 4, 2011 · Posted in ,

When counseling patients about the complications of radical prostatectomy, most urologists spend a great deal of time discussing impotence and incontinence.  Few urologists, in contrast, discuss another very common but not well known postoperative problem: shortening of the penis.  While not noticed by some men, shortening of the penis can lead to significant problems with self esteem, sexual satisfaction, and quality of life after radical prostatectomy for prostate cancer.  Despite these significant consequences, many urologists disregard it  while others are simply not familiar with it.  As a result, many patients agree to and proceed with a radical prostatectomy without being aware of this postoperative issue and do not take any steps to minimize it.  In this post, I will discuss shortening of the penis, how often it occurs and what, if anything, can be done to prevent or limit its occurrence.

It Happens More Often Than You Think

Despite its obscurity, shortening of the penis is actually a common complaint of men undergoing radical prostatectomy.  Studies have shown that nearly half of men undergoing prostatectomy demonstrate some decrease in penis size postoperatively.  The average decrease in flaccid penis length at 1 year after surgery has been reported to be about 1.3cm.  A larger decrease of 2.3cm (nearly an inch) has also been reported in the length of the erect penis after the same period of time.  One study reported that, after prostatectomy, almost 20% of men lose 15% of the length of their penises when measured in the erect state.  You can imagine that such a decrease is noticeable and disheartening for a large number of men.

What Causes Shortening of the Penis ?

Many theories have been advanced, speculating about the root cause of shortening of the penis.  One such theory that has been debunked (for the most part) is that of tension from the urethra.  It was thought that because the prostate is removed, tension is created in bringing together the bladder and urethra.  As a result, the urethra is pulled up towards the bladder, simultaneously pulling the penis into the body and shortening it.  This theory does not make much anatomic sense as the urethra is tethered to the part of the pelvic muscles called the urogenital diaphragm.  As a result, the urethra cannot really get pulled much in either direction, limiting its ability to shorten the penis.

Recently, a more comprehensive theory has emerged which divides the causes for shortening of the penis into short and long term.  Shortening of the penis can first be noticed from the time of catheter removal through the first month or so after surgery.  This initial shortening is thought to occur directly as a result of damage to the nerves traveling around the prostate that are responsible for erections.  Damage to these nerves at the time of surgery leads to stimulation and hyperfunctioning of nerves that are part of the sympathetic nervous system.  These nerves, responsible for the “fight or flight” response, release adrenaline which leads to contraction of  smooth muscle in the body.  These sympathetic nerves send impulses to the penis where the smooth muscle of the erectile bodies contract.  This contraction of the penis pulls it into the body and makes it appear shorter.  Fortunately, this is a short term response which is reversible.

Long term shortening, in contrast, is caused by progressive, irreversible changes to the structure of the penis.  These changes are brought about through two mechanisms:

1)     Permanent nerve damage experienced during surgery:  When nerve damage occurs anywhere in the body, the tissues to which the damaged nerves supply impulses usually experience atrophy or breakdown.  This can often be seen in paraplegic, wheelchair bound people in whom the loss of nerve signal  causes a significant decrease in the size and muscle mass of the legs.  The same can be said of the penis after nerve damage during prostatectomy.  If permanent nerve damage occurs, the lack of impulses to smooth muscle of the penis leads to an atrophy or breakdown of the tissues responsible for erections and causes the penis to shrink both in length and girth.

2)     Decreased transport of blood and oxygen through the erectile tissue of the penis: As is widely known, loss of erections is a common side effect of prostatectomy, particularly in the first few months after surgery.  Erections lead to the circulation of oxygen-rich blood through the penis which nurtures it and keeps it healthy.  If no erections occur for extended periods of time, the lack of circulation of this oxygen-rich blood leads to fibrosis or scarring of the erectile tissue of the penis, also leading it to shrink in terms of length and girth.  This phenomenon has been demonstrated both through experimental animal studies and human studies.

Preventing Shortening of the Penis

While causing problems like shortening of the penis, radical prostatectomy still remains a vital tool in the fight against prostate cancer.  Most men will proceed with surgery to cure their prostate cancer even with the knowledge that a prostatectomy may significantly decrease the length of the penis.  But what if we could prevent or, at least, limit shortening of the penis after prostatectomy?  Studies have demonstrated that this, indeed, is possible.  While short term, reversible, shortening of the penis cannot truly be avoided, long term, permanent, shortening can be prevented or limited. 

The most effective method of minimizing the chance of shortening the penis depends on avoiding the permanent damage to the penis that I described above.  This requires some work by both surgeon and patient.  First, damage to the nerves around the prostate needs to be avoided by the surgeon.  The way to accomplish this task is to perform a meticulous nerve sparing prostatectomy.  Of course, every prostatectomy is always a fine balance between cancer control and nerve sparing.  That is why a skilled, experienced surgeon is vital to performing a prostatectomy that cures cancer with a minimal sacrifice of the nerves. Studies have demonstrated that the most important, independent, predictor of shortening of the penis is nerve sparing during surgery.  In fact, one study demonstrated that successful nerve sparing prostatectomies performed on potent men who maintained good erections after surgery led to no change in the length of the penis whatsoever.

Once the surgery is performed, the rest of the responsibility to prevent long term shortening of the penis falls on the patient.  Studies have shown that various “rehabilitation” strategies can ensure the continued circulation of oxygen-rich blood through the penis and prevent the scarring of the penis that I mentioned above.  As  a result, men who undergo such “penile rehabilitation” after surgery have demonstrated less extensive shortening of the penis.  One study, for example, evaluated the benefit of using a vacuum erection device daily from the time the catheter is removed after nerve sparing radical prostatectomy.  Measurements of penis length prior to and 3 months after surgery demonstrated a decrease in the length of the penis by more than 1 cm in only 3% of men who used the vacuum erection device regularly as opposed to 67% of men who were not compliant with the protocol.  Another study of men undergoing nerve sparing robotic prostatectomy evaluated a rehabilitation regimen of daily Viagra for 9 months after surgery. The study found that at 1 month after surgery, men suffered from a decrease in penis length of about 0.6cm.  This decrease in length was thought to be due to the short term, reversible process described above.  By 9 months after surgery, however, this decrease in the length of the penis was no longer present as the measured penis length appeared to be equivalent to that noted preoperatively.  Hence the short term process was reversed and the long term, irreversible process of shortening was prevented through the regimen of rehabilitation.

Take Home Message

Shortening of the penis is a very real complication of radical prostatectomy.  Although not often talked about, this phenomenon can lead to significant impairment of self esteem and a decrease in the quality of life for men undergoing surgery for prostate cancer.  The occurrence of shortening of the penis is lamentable in that, for the most part, it is preventable.  With meticulous nerve sparing, permanent nerve damage and subsequent damage to the penis can be limited.  Similarly, through a regimen of penile rehabilitation (via pills, injections, or pumps), many men can prevent or decrease permanent scarring of the penis and the inevitable, irreversible shortening it causes.




 

   


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Is This The End Of Prostatectomies?

Sunday, May 22, 2011 · Posted in ,

The annual meeting of the American Urological Association was rocked this year by the release of  PIVOT (Prostate Cancer Intervention Versus Observation Trial).  Journalists at the event stated that the presentation of the data brought a “collective gloom” over the hall filled with urologic surgeons.  The reaction is not surprising as the study basically concluded that radical prostatectomy is not necessary for the management of anything other than aggressive prostate cancer.  So does this study mark the beginning of the end for the widespread use of radical prostatectomy for the management of prostate cancer?  I think that in order to answer this question we first need to take a closer look at the design and results of the study.


PIVOT Study

The PIVOT study was created in 1994 to determine whether the use of prostatectomy in treating prostate cancer added to overall survival and cancer specific survival.  The study was designed to recruit 5000 men (less than 75 years of age) with newly diagnosed, localized prostate cancer.  Men eligible to proceed were then randomized into one of two groups:
1)      Prostatectomy: Actually, only 78% of men in this group underwent prostatectomy   while the rest underwent other therapies
2)      Observation:  Patients in this group did not undergo any treatment aside from palliative therapy for symptomatic management of metastatic disease

The patients in the two groups were then followed for an average of 10 years .

Results of the PIVOT Study

Before I get into the results of the study, I want to stress that just the basic data has been provided and, until the actual paper is published, the nitty gritty of the data cannot be really assessed.  Nonetheless, even the basic data that is available definitely provides a starting point for discussion.

Out of the 5000 patients recruited for the study, only about 700 of the eligible patients actually agreed to proceed.  These 700 men were then divided into two groups with, on average, similar characteristics in terms of age and degree of prostate cancer.  After an average of about 10 years of follow up, the results reported by the study were definitely eye opening:

1)      While 48% of the men in this study died within the 10 years of follow up, only 7% died from prostate cancer
2)      Prostatectomy led to an insignificant, absolute 2.9% increase in overall survival. 
3)      Prostatectomy led to an insignificant, absolute 2.7% increase in prostate cancer specific survival.
4)      For high risk patients with PSA greater than 10, prostatectomy provided a significant, 7.2% increase in survival.

Initial Reaction to the Results

Upon first glance at these results, it is not unreasonable to come to the conclusion that radical prostatectomy is an unnecessary procedure for the majority of men diagnosed with prostate cancer.  After all, with PSA screening, most men are diagnosed with low or moderate risk disease and a PSA well below 10.  This trend towards early stage disease is also demonstrated by the study itself in that 70% of men participating in the study had a Gleason score of 6 or less and 72% were classified as either low or intermediate risk.  If we take the study population as a microcosm of the general population, we would argue that over 70% of men simply do not need to undergo prostatectomy (or any other treatment for that matter) to treat prostate cancer.  We would argue that men should not expose themselves to the significant risks and quality of life impacts of prostatectomy for only a minimally higher chance of surviving prostate cancer.  We would then conclude that treatment for prostate cancer should be reserved only for those men with high risk cancer and a PSA greater than 10.  With the general data provided, these conclusions may very well all be true.  Before hanging up the scalpel for good, however, I thought I would take a closer look at the data.

Digging a Little Deeper

After my initial shock from these results wore off, two big questions became prominent in my mind:

1)  How healthy were the men in the study?  As I noted above, approximately half of the men in the study died within the 10 years of follow up.  Only a small percentage of these men died of prostate cancer.  There are two possibilities to explain the small number of men dying from prostate cancer:

A)   The low risk prostate cancer that afflicted most of the men in the study was just not that lethal.
B)   The men in the study had other health problems that were more lethal than prostate cancer.

The answer is probably a mix of both.  Men with significant medical problems (heart disease, stroke, diabetes) often do not live long enough to be affected by or to die from prostate cancer.  At this point you are probably thinking that I am proving the point of the study: most low or intermediate prostate cancer does not need to be treated.  However, not all men have significant medical problems.  Healthy men, particularly healthy young men, may well live long enough to suffer from and even die from prostate cancer.  A famous, large European study recently demonstrated that, when looking at men as a whole, 50 men with prostate cancer would need to undergo prostatectomy to save one life from prostate cancer.  HOWEVER, a follow up study then went on to demonstrate that, when looking at HEALTHY men, only 4 men with prostate cancer would have to undergo prostatectomy to save one life from prostate cancer.  Quite a difference! Unfortunately, I believe that the PIVOT study is too small to demonstrate this type of distinction.  Nonetheless, I hope that when the final, more specific, data from the trial is published, information about the overall health of these men is included to help us determine whether their overall health precluded them from benefiting from prostate cancer treatment.

2) Why was the study only carried out for 10 years?  During my residency training I, like most other urologists-to-be, learned that men with a life expectancy less than 15 years probably should not undergo aggressive treatment for low risk prostate cancer.  Studies have demonstrated that prostate cancer typically takes around 15 years to create metastatic disease significant enough to be lethal.  As a result, men that did not expect to live that long would not derive any benefit from treatment.  This previous data makes it not very surprising that, at 10 years, only a minimal survival advantage was noted in PIVOT for men undergoing treatment versus those men that chose to observe their cancers.  At 10 years, metastatic prostate cancer starts to present itself but usually not to the extent that can kill.  I would imagine that, like in previous studies, metastatic disease was found more often in men in the observation arm of the PIVOT trial.  I am not sure, however, that this was an endpoint recorded for the trial.  I would bet that if the investigators running the PIVOT trial would continue to collect data up to the 15 and 20 year marks, the tiny difference demonstrated in the survival curves  of men in the treatment versus observation arms of the study would prove to be only the initial separation point of two very divergent curves.

Of course, the average age of the men in the study was 67.  Men in this age group have a life expectancy of about 15 years so, for them, a survival benefit achieved 15-20 years after surgery is pretty useless.  But what about a 50 year old man?  His life expectancy is over 30 years.  For him, a survival advantage 15 years after surgery can mean the possibility of 15 extra years of life.  I don’t think the value of this survival advantage is really debatable.  This concept was demonstrated in a recent study of Scandinavian men with prostate cancer which, after 15 years of follow up, demonstrated a 38% survival advantage for men younger than 65 years of age undergoing surgery as opposed to observation.  For this reason, I feel that while the 10 year survival data from this study may be helpful in guiding a treatment (or no treatment) decision for a man in his late 60s or 70s, the data is not relevant to a healthy man in his fifties. 

Take Home Message

The purpose of this post was not to criticize the PIVOT trial.  Any well run, randomized trial evaluating 700 men deserves significant attention and must be taken very seriously.  The study, indeed, reaffirms many important concepts in the management of prostate cancer.  First, men with low risk prostate cancer should definitely be advised of the option of active surveillance, particularly if they are in their 60s or older and/or if they have significant medical problems.  These men, as the study demonstrates, may not derive significant benefit from prostatectomy or other treatments.  In the same vein, men with aggressive prostate cancer should be offered treatment, even if they are older or may have some other medical problems.  These aggressive cancers, as demonstrated by PIVOT, can lead to premature death even within a 10 year time frame. 

What the PIVOT trial does NOT prove to me, however, is that prostatectomy is useless for YOUNG, HEALTHY men with low or intermediate risk prostate cancer. Of course, these young men need to be counseled on the risks and quality of life implications of treatments such as prostatectomy. They need to be told that any survival advantage from surgery or other treatments would not be enjoyed for more than a decade. They also need to be advised of the risks and benefits of active surveillance as well.  However, until large, randomized, long term studies prove otherwise, I believe that these young, healthy men should not be told that treating their prostate cancer is unnecessary.


 

   

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Prostatectomy Complications: Risks To Know About

Wednesday, April 13, 2011 · Posted in ,

Deciding to proceed with surgery to cure cancer can be a daunting task.  This decision can be even more difficult in the case of prostate cancer.  With so many treatment options available and, for some, even a viable option of not treating the cancer, the decision to go ahead with prostatectomy is certainly not one that anyone takes lightly.  As a result, when counseling my patients about surgery and other treatment options for prostate cancer, I try to be very thorough about explaining all the potential risks of the procedure.  That way, they really have an understanding of what they can be potentially getting themselves into.  The purpose of this post is to review the various risks of prostatectomy, both traditional and robotic.  Many of the risks of these two types of surgery are identical.  However, I will point out any disparity in risks between the two surgeries when, in fact, there is one. For the purpose of clarity, I have divided the complications into three types: 

  1. Intra-operative
  2. Postoperative
  3. Long Term


Intra-operative Complications: These are the problems that could potentially occur at the time of surgery.

1.      Bleeding:  Radical prostatectomy, the traditional surgery for prostate cancer, has always been associated with bleeding.  As the procedure has been refined, the average blood loss has decreased but remains significant.  On average, a radical prostatectomy tends to result in a loss of about 500-900 milliliters of blood.  While young, healthy people can usually tolerate such blood loss without any untoward effects, older, sicker men may not tolerate this type of blood loss as well.  As a result, most men that undergo traditional surgery donate a unit of their own blood a few weeks prior to surgery so that they may receive it back at the time of surgery and not need to rely on blood from the blood bank ( with its associated very low risk of communicable diseases).  Robotic surgery, in contrast, usually results in significantly less bleeding (about 100-200 milliliters).  This difference is accounted for by the fact that the robotic surgery involves a process called insufflation in which the abdominal cavity is stretched with gas to allow for room for the surgeon to see and work.  This gas creates pressure which stops minor bleeding from veins that would otherwise bleed freely during open surgery.  As a result of this decreased bleeding risk, many robotic surgeons do not request patients to donate blood prior to the procedure.

2.      Damage to the bladder or ureters: Because the bladder sits right on top of the prostate, removal of the prostate sometimes leads to injury of the bladder.  Most of these injuries are pretty minor and can be fixed at the time of surgery pretty easily.  One injury that is a little more complicated is the type that occurs to the ureters, the tubes that carry urine from the kidneys to the bladder.  Sometimes, during prostatectomy, the surgeon inadvertently cuts the ureter or the opening of the ureter into the bladder.  If this occurs, the surgeon would need to repair this injury by reconnecting the ureter tube to another location in the bladder.  This type of procedure, called ureteral reimplantation, is something that urologists are very comfortable doing and, so, usually does not result in any long term problems after surgery.

3.      Damage to the Rectum: For those of you who have had a prostate biopsy, you probably remember that the biopsy was done through the rectum.  The reason for this approach is that the rectum sits right behind the prostate and is separated from it by a thin lining of tissue.  During a prostatectomy, the prostate is occasionally very stuck to the rectum and, upon trying to separate the prostate from the rectum, the surgeon can make a hole in the rectum.  If the hole is small and the patient has had a bowel preparation (enemas and oral laxatives) the surgeon can often just repair the hole with some stitches.  If the hole is big or the patient has not had a bowel preparation, however, a colostomy occasionally needs to be performed.  A colostomy is a procedure where the colon is separated from the rectum (where the hole is) and brought out to the skin to a bag.  The stool is collected in a bag and prevented from going down to where the hole in the rectum is located, allowing the hole to heal.  After a few months, a surgeon can then reverse the colostomy by reattaching the colon back down to the rectum and allowing the patient to, once again, have normal bowel movements.  Fortunately, this type of complication occurs less frequently than 1% of the time.  However, this is not much consolation if you are one of those few people who have to defecate into a bag for a few months. 

4.      Complications of Anesthesia:  Any surgery requiring general anesthesia carries the risk of serious complications related to the anesthesia.  These potential problems include heart attack, stroke, a blood clot in the lungs, aspiration of stomach contents (i.e. food) into the lungs, and even death.  Prevention of these complications requires a thorough evaluation prior to surgery to assess medical and anesthesia risks.


Postoperative Complications: Even when a prostatectomy is carried out without a hitch, occasional problems can be noted from the time immediately following surgery to a few weeks following surgery.

1.        Infection:  Infections are not a common problem after prostate cancer surgery.  With adequate antibiotics around the time of surgery, most patients do quite well in avoiding infections.  For some patients, however, infections do occur.  Most commonly, an infection occurs in the incision, making it red, hot, and occasionally leaking pus.  For others, infections can occur in the urine as demonstrated by cloudy or bloody urine and pain over the bladder.  Both of these types of infections can be successfully managed with antibiotics.

2.        Hematoma: Sometimes bleeding is not noted at the time of surgery, allowing blood to accumulate over time within the area where the surgery was performed.  This large accumulation of blood and clot is called a hematoma.  While such collections are sometimes not even noticed by patients, occasionally they can cause a great deal of pain and discomfort.  Rarely, they can even push so much on the bladder as to tear the anastamosis (the surgical connection made between the bladder and urethra tube).  This can be a very serous complication requiring surgery to re-establish the connection.  Many times, however, less severe hematomas can be managed conservatively with rest, pain medicine, and time.

3.        Wound Issues:  The most common problem with surgical wounds is infection (as described above).  Less commonly, wounds can start draining fluid. Occasionally this leakage is due to a fluid collection the builds up underneath the skin called a seroma.  This usually needs to be drained by your surgeon in the office.  More rarely, the leakage can be due to a tear in the deep closure of the wound.  This type of leakage may require a return visit to the operating room to re-close the deep parts of the wound.  Either way, leakage from the wound should ALWAYS be reported to your surgeon. 

4.        Catheter Malfunction:  After prostate surgery, the catheter in place which drains urine from the bladder really serves as a lifeline for the bladder.  If the catheter stops working, there is no way for the urine to drain.  Removing or replacing the catheter incorrectly can jeopardize the anastamosis between the bladder and the urethra, resulting in the potential need for repeat surgery and severe, chronic leakage of urine.  As a result, I tell my patients after prostatectomy that the ONLY person who should remove or replace a urinary catheter in a man after prostate cancer surgery should be a urologist.

5.        Bloody Urine:  Occasionally, for a few days after prostatectomy, blood in the urine could be noted.  This can be due to irritation of the bladder from the catheter or to some minor oozing after surgery.  Either way, this blood in the urine can usually be managed conservatively, with periodic flushing of the catheter with saline.  Rarely does blood in the urine remain a long term problem.

6.        Blood Clots in Leg Veins:  Any surgery that involves a patient lying down for prolonged periods of time could predispose him to blood clots in the veins of the legs.  This is especially true of surgeries performed in the pelvis, like prostatectomies.  A blood clot in a leg vein, otherwise known as a deep vein thrombosis (DVT), often presents itself as pain in the calf or behind the knee, swelling of the calf or leg, or redness of the leg.  Men with these symptoms after prostate surgery should notify their surgeon or another medical doctor immediately because these clots can progress and travel to the lungs, which can be fatal.  Once diagnosed through an ultrasound of the leg, a DVT is treated with several months of blood thinning medication.


Long Term Complications:  While the complications mentioned above sound frightening, they fortunately occur fairly rarely.  Long term complications, in contrast, occur much more frequently BUT are a lot less scary.

1.      Impotence:  About half of men undergoing prostatectomy develop erectile dysfunction following surgery.  Younger men and those with strong erections prior to surgery are more likely to maintain some erections after surgery.  Regardless of the extent of impotence after surgery, most men are able to sustain erections again after surgery with the variety of treatment options available for this problem.  I have covered the management of erectile dysfunction following prostatectomy in a previous post and you are welcome to review it if you are interested:

http://prostatecancersymptomstips.blogspot.com/2011/04/sex-after-prostatectomy-yes-we-can.html

2.      Incontinence:  Leakage of urine is also a common occurrence after prostatectomy.  Incontinence occurs because the mechanism that controls urination is intimately associated with the prostate.  During a prostatectomy, when the prostate is removed, this mechanism can be damaged, leading to leakage of urine in the short or long term.  Approximately 15% of men demonstrate long term incontinence after prostatectomy.  Most men are able to become dry with a combination of Kegel exercises and time.  Kegel exercises are performed by squeezing the muscle that you normally use to hold in urine when you have the strong desire to urinate.  I advise my patients to perform these exercises even PRIOR to surgery and to continue performing them over 100 times per day following surgery.  I have found that men that start early and are diligent with the exercises tend to regain their continence sooner and more effectively.  Urinary leakage can continue for months after surgery.  By about 6 months to a year, most men have attained a level of dryness that will most likely remain chronically.  For most men, this usually means either complete dryness or the need to wear a light pad in the underwear for some minor leaks during rigorous activity.  For 10-15% of men, however, urinary leakage can be much worse, requiring diapers.  For these men, a surgery can be performed to insert a device called an artificial urinary sphincter.  This device can be used to mechanically overcome leakage of urine.

3.      Dry Ejaculate:  Even for those men that regain complete erections after surgery, sex is never exactly the same.  As you may remember from my previous posts, the prostate and seminal vesicles produce most of the semen that men ejaculate when reaching an orgasm.  During surgery, the prostate and seminal vesicles are removed and the connection to the testicles is severed (like a vasectomy).  As a result, when men have an orgasm after surgery, they have a dry ejaculate.  While they still feel enjoyment from an orgasm, it feels a little different.  Because no semen is ejaculated, men are also considered infertile after prostatectomy.

4.      Bladder Neck Contracture:  About 5% of men undergoing prostatectomy develop scar tissue at the connection between the bladder and urethra tube (where the anastamosis was performed).  As a result, these men may experience difficulty emptying their bladders or leakage of urine after a period of dryness.  Fortunately, this complication can be repaired fairly easily with a minimally invasive, outpatient procedure.


While this post is not a completely exhaustive list of surgical complications after prostatectomy, I feel that it definitely provides a pretty comprehensive and objective view of all the major things that COULD go wrong during or after prostatectomy.  The purpose of this post was not to scare anyone away from surgery.  I just feel that with all of the options available to men with prostate cancer, anyone deciding on a particular treatment option needs to feel very comfortable with his choice.  This comfort, in my experience, comes with knowledge of what he is getting himself into.  In addition, for those men that proceed with prostatectomy, an understanding of potential complications can help reduce anxiety if and when these problems occur.  For other men, having enough information to identify serious complications in a timely fashion can be the key to a successful outcome.


 

   
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