(1)
University Hospitals Leuven, Leuven, Belgium
(2)
Tenon Hospital, Hôpitaux Universitaires Paris-EST, Assistance publique Hôpitaux de Paris, Université Pierre et Marie Curie Paris 6, Paris, France
(3)
Department of Urology, Sohag University Hospital, Sohag, Egypt
(4)
Radboud University Medical Center, Nijmegen, The Netherlands
(5)
Institute of Urology and University College London Hospitals, London, UK
Background
All health professionals are familiar with the problem of stress urinary incontinence in females. Female anatomy predisposes to incontinence of urine due to sphincter weakness and in particular in association with childbirth. Health professionals however are less likely to be aware of the problem of stress incontinence in males, which does not usually occur as a primary condition. Since a male is not subjected to childbirth, the pelvic floor does not become weak unless it is affected by specific medical conditions. Thus stress urinary incontinence is much less common in males and less likely to present. Men have a tendency to draw less attention to the problem of urinary incontinence. Although a cause of much distress, incontinence in males tends to often remain a hidden condition. Incontinence is a common condition worldwide and leads to much suffering and in addition significant cost to society.
Incontinence is a distressing condition, and thus an understanding of the causes of male incontinence, its investigation and treatment is essential to those involved in treating male patients. Resolving incontinence brings major benefits in improvement of quality of life.
Male stress incontinence has to be distinguished from other types of urinary incontinence, and the condition alone may be associated with other conditions affecting bladder storage and emptying, which need to be excluded or treated if they coexist.
Male Continence Anatomy
Male continence depends upon an intact and functioning neural system. The bladder needs to be able to store urine to a normal volume (circa 500 ml) and with low filling pressure (less than 15cmH20). With these provisos, the male continence mechanisms are an intact and functioning bladder neck mechanism (bladder neck, internal sphincter) and an intact external striated sphincter mechanism (rhabdosphincter). Any changes in any of these structures either from disease or surgery can affect continence. Surgery has had a major effect on the continence mechanisms in men and has lead to an increase in the incidence of male stress incontinence.
Causes of Male Urinary Incontinence
Transurethral prostatectomy and the alternatives are associated with a relatively low incidence of post-operative incontinence. The incidence has reduced significantly over the years and is probably due to advancing technology allowing excellent views of the surgery by camera techniques and more effective supervision of training.
Male stress urinary incontinence has become more common in recent years because of the increase in the use of surgical treatment for prostate cancer by radical prostatectomy. Whether a radical prostatectomy is performed by the open surgical route or by laparoscopic or robotic means, incontinence will occur in a proportion of men due to sphincter weakness. It is not surprising that men become incontinent of urine after a radical prostatectomy. The bladder neck mechanism is lost and the sphincter may be weakened by resection of part of that sphincter. There is also a loss of support to the urethra by division of the puboprostatic ligaments and incision into the endopelvic fascia. Fortunately most men are continent after a radical prostatectomy or regain continence over a period of months. However, there will be men who will have persistent stress incontinence, which will require treatment.
There are few primary conditions that can give rise to male stress incontinence. The principal one being lower motor neurone spina bifida patients, who will have a poor or acontractile bladders and sphincter weakness incontinence. Sphincter weakness incontinence can occur in patients after a spinal cord injury. A lower motor neuron lesion will be associated with pelvic floor denervation. Patients tend to have poorly contractile or acontractile bladders and thus tend to strain to void if not using intermittent catheterisation. They may also have sphincter weakness incontinence or develop stress incontinence with time due to additional pelvic floor weakness.
One potential cause of stress incontinence but hopefully rarely seen follows a pelvic fracture injury where a urethral rupture has led to a stricture treated by a urethroplasty. The sphincter may be weakened by such surgery, and in later life, should bladder neck or prostatic surgery take place, there is a significant risk of incontinence occurring.
Clinical Practice
Clinical Assessment
Symptoms of stress incontinence are those associated with any event that increases intra-abdominal pressure beyond the resistance within the bladder outlet/sphincter mechanism. Thus coughing, sneezing, laughing and movement will give rise to incontinence of urine. In a catastrophically wet patient, continuous incontinence may be present. This can and does occur after a radical prostatectomy or TURP.
Male patients with stress urinary incontinence tend to be continent at night provided the bladder pressure is stable. However, once movement occurs to the upright position, incontinence may develop. Classically, in this group of men, stress incontinence occurs when moving from the sitting to the standing position. Certain activities also make a man wetter, such as playing golf or tennis.
During history taking, it is important to gain information about the patient’s bladder function. This is an assessment of urinary frequency, nocturia, urgency and urge incontinence symptoms, which are likely to be due to an overactive bladder or poorly compliant bladder.
Voiding symptoms should be discussed – hesitancy, the state of the stream, terminal and post-micturition dribbling. Straining usually represents a stricture or poor bladder contractility as does a feeling of incomplete emptying.
The degree of urinary leakage with stress incontinence should be assessed. The number of pads used and how wet they tend to be should be assessed. A pad weighing exercise should take place in all men with stress incontinence as it will indicate the degree of incontinence, may affect the choice of surgery and can be used for an assessment of post-treatment success. Some patients will be wearing a conveen sheath, which allows a more accurate knowledge of urinary loss.
Diagnostics
The first part of investigation of course is to take a careful history, then perform a clinical examination. What is most useful is to see what sort of pad the patient is wearing and whether it is wet and if leakage occurs with coughing or sneezing. The genitalia should be assessed and look for excoriation from urine wetness. A rectal examination can be helpful in patients with generalised pelvic floor weakness caused by neurological dysfunction, but it is not usually necessary in patients who have had a radical or transurethral prostatectomy.
A frequency volume voided chart is important in assessing fluid intake as reducing fluid intake may reduce incontinence episodes. Volumes voided will give an indication as to whether the bladder is able to store urine, and this particularly can help at night if a patient can hold urine during the night as it is useful for the later management of that patient.
Voiding function should be known and this can be simply assessed with a free flow rate based upon a volume voided more than 150mls and a post-micturition residual assessment. It is essential to know that the bladder is emptying satisfactorily particularly if any surgical intervention is to be considered.
Urodynamic Investigations
Should we use urodynamic investigations in the incontinent male patient? The assessment of bladder function in a patient with stress incontinence by urodynamic studies can be controversial. However, urodynamic studies are very useful in understanding storage and emptying bladder function. If combined with x-ray screening (video urodynamic studies), much useful information can be gained. Filling cystometry will demonstrate whether or not the bladder has overactivity, and this can be useful in providing the start of treatment of a patient with mixed symptoms. Voiding function is assessed by a pressure flow study, and if obstruction is present, this will need to be dealt with before treating stress incontinence. The benefit of video screening of the bladder and outlet during urodynamic testing gives a view of the bladder shape, presence of the competence or incontinence of the bladder neck and whether or not stress leakage is taking place. The site of obstruction during voiding cystometry will be screened. The presence of reflux and assessment of bladder emptying is also seen with video urodynamic studies. It is the author’s view that videourodynamic studies have an essential place in the management of the patient with urinary stress incontinence.
Decision to Treat
Any male patient suffering with stress urinary incontinence will be distressed by the symptoms. Most patients are not particularly accepting of urinary leakage. Often there is a concern about urine smell. There is the ongoing problem of wearing pads. These are expensive to purchase and not always available on prescription. The penis may become sore due to persistent urinary leakage. Most patients are therefore very keen to become dry.
Containing the Incontinence
Containing the urinary loss may be acceptable to some patients. A single pad for a minimally wet patient may be sufficient to contain the leak and be acceptable.
For the patient with a greater degree of incontinence, a conveen sheath applied to the penis and a leg drainage bag may be comfortable. For elderly patients, this may be a suitable choice. This may also be suitable for the patient with neurological dysfunction such as a spinal cord injury. The old-fashioned penile clamp is often overlooked and can be beneficial to some patients who would like to be out and about without wearing a pad. Wearing a penile clamp for a short period of time whilst out and about may be acceptable as a short-to-medium-term solution. It is not a solution to the problem but can be a helpful method of containment.
Conservative Options
Conservative options for post-prostatectomy incontinence can be palliative (focused on comfort of the patient, with no aim at curing incontinence itself) or active. The former includes penile clamps, penile sheaths and protections, and the latter includes pelvic floor muscle training and duloxetine.
Palliative Options
Penile clamps have been used for years for post-prostatectomy incontinence management. A clinical trial has compared three types of clamps (Cunnigham device, U-shaped clamp and C3 clamp), in a randomised, open-label study. The devices evaluated have shown high efficacy but variable tolerance among patients. The use of penile clamp is not recommended by currently available clinical guidelines.
Methods for containment of urine have been extensively reviewed in the literature. In men with post-prostatectomy incontinence, condom catheters are seen as a valuable solution. About protections, there are no reliable data to state whether a type of protection is better than another. Different pads have their advantages and disadvantages; they are chosen depending on the patients’ preferences, degree of incontinence and activity.
Lifestyle habits have not proven to substantially modify symptoms. However, abnormal fluid intake or bad habits have to be modified, according to good medical practice.
Therapeutic Options
Behavioural therapy such as pelvic floor muscle training has been evaluated in the field of post-prostatectomy incontinence. It is recommended by the current EAU Guidelines and the ICS document for management of post-prostatectomy incontinence with a level of evidence grade 2. Many different types of pelvic floor muscle training programmes have been described, according to the types of exercises, training and degree of supervision, timing (preoperative, immediate post-operative or delayed), use of biofeedback and associated stimulations. According to a review by the Cochrane collaboration, there is no influence of physiotherapy on the continence rates after one year. However, pelvic floor muscle training can be recommended to fasten continence recovery in a post-operative setting. Early rehabilitation seems the best choice for patients who want to get continence back within a minimal time frame. Supervised training is probably better than alone exercises, but biofeedback has no clear impact on the results. It is thus not routinely recommended when pelvic floor muscle training is prescribed.
Duloxetine has been proposed as a medical treatment of post-prostatectomy incontinence. The rationale for the introduction of this treatment is based on the results obtained in women for stress urinary incontinence management. This drug is a serotonin-noradrenalin reuptake inhibitor, acting on the Onuf’s nucleus by blocking the reuptake of noradrenalin and serotonin, thus raising the activity of pudendal motor neurons, leading to increase of striated urethral sphincter tonus and detrusor relaxation. Duloxetine has proven its efficacy in cases series and in one randomised controlled trial at the dose of 80 mg. The drug has been shown to be superior to placebo at an 80 mg/day regimen. However, the use of duloxetine for male post-prostatectomy management is not recommended by current clinical guidelines, because of the paucity of the studies published. It is sometimes used off-label. Moreover, this treatment can lead to numerous side effects, like fatigue, sweat, insomnia, loss of libido, constipation, nausea, diarrhoea, dry mouth, anorexia or psychiatric issues.
Surgical Treatment
Bulking Agents
In some men with mild to moderate SUI, urethral bulking agents are a less effective treatment, with early failure rate of a 50 % and gradual loss of effect with time (LoE: 3; GoR: C). Bulking agents have been used over many years to treat post-prostatectomy incontinence. Collagen was the first material used for treating stress incontinence but had very poor outcomes. There have been a number of other injectable agents used for treating stress incontinence in men. The popular current ones available are Macroplastique and Coaptite. The success rate however with these treatments is relatively poor with only approximately 34 % of men benefiting in the long term. The only benefit of injectable treatment is that it is a minimally invasive treatment without any incisional surgery, and if this technique works, it can be beneficial and satisfying for the patient. It is important however to warn the patient that the results may not last for long and the incontinence condition can be worsened in a small percentage.
Male Slings
What Do the Guidelines Say?
According to recommendations and available guidelines, the standard surgical management for male stress urinary incontinence is the implantation of an artificial urinary sphincter. Current clinical guidelines mention the use of male slings as an alternative to the implantation of an artificial urinary sphincter, especially in men with mild to moderate symptoms. Overall, all guidelines are in accordance that the level of evidence supporting the use of male slings is rather low, mainly based on cohort studies (generating grade C – level of evidence three recommendations). The current clinical guidelines distinguish the fixed compressive male slings (like InVance™), transobturator repositioning male slings (like AdVance™) and adjustable male slings, like Argus™.
InVance™ is considered as a historical device in some countries where it has been removed from the market. Based on available data, this sling has been shown to lead to heterogeneous cure rates, with a high risk of post-operative infection, erosion and removal of the device. At least 20 different case series have been published about InVance™ according to reviews of the literature, up to midterm follow-up. Infection has been reported being as high as 15 % of cases, and other complications included recurrence of incontinence, acute urinary retention and perineal pain.
Transobturator repositioning AdVance™ male sling has been introduced in 2007, and there has been multiple prospective studies showing the efficacy of this device. After AdVance™ implantation, 50 % of patients are being dry, 25 % are improved and 25 % fail. However, the complication rate has been proven to be very low, with a very limited rate of erosion and infection. The usual complications are rather transient urinary retention (around 10 %) and perineal pain (less than 10 %).
The Argus™ male sling is considered by the current guidelines as an ‘adjustable’ male sling. The guidelines point out the paucity of the data supporting the use of Argus™ system, with published data on a few hundreds of patients and limited follow-up. Based on the available data from the literature, there is grade 3 evidence that Argus™ system can cure SUI (subjective cure rate of around 57 %, but very heterogeneous according to available studies), but the rate of complications (especially sling explantation) is considered as high. External comparison of available cohort studies seems to show that there is no additional benefit with the Argus male sling compared to other types of slings. Recently, a small direct comparative trial between Argus™ and AdVance™ sling has shown no significant difference in efficacy outcomes between after midterm follow-up.
Overall, male slings are reasonable options for management of mild to moderate stress urinary incontinence and are a possible alternative to urinary sphincter implantation. Almost all evidence is level 3, and there is no clear data showing the superiority of a sling over another.
Clinical Practice and Results
Male sling implantation is considered in clinical practice as an alternative to the artificial urinary sphincter in men, particularly for post-prostatectomy incontinence management. Before considering this option, a specialised evaluation is required and includes:
Complete medical history: date and type of prostatic surgery, alternatives causes of urinary incontinence such as neurological diseases, additional treatments (pelvic radiation therapy), cancer status (PSA level).
Evaluation of the symptoms: a 24 h pad test is welcome preoperatively to check the severity of incontinence (estimation of pad use is also widely used). An objective evaluation by validated questionnaires is useful.
Endoscopy of the urinary tract: this is often required to check the integrity of the urethra and the vesico-urethral anastomosis. It also permits to rule out a urethral disease (such as stenosis). Some authors have also proposed that endoscopy of the urinary tract make a ‘repositioning test’ possible, in order to check for residual sphincter function.
Urodynamic study: this is often required to rule out bladder dysfunction and detrusor abnormalities and identify the intrinsic sphincter deficiency. For some authors, the interest of urodynamics has to be discussed, but a uroflowmetry and post-void residual estimation seem required.
Urine culture is also mandatory before surgery, as well as the preparation for anaesthesia.
This rigorous and comprehensive preoperative workup sets the basis for a rigorous evaluation, based on patient characteristics. Indeed, some predictive factors influencing outcomes after male sling implantation have been proposed in the literature (mostly reliable for AdVance™ sling). The factors associated with a higher success rate are absence of pelvic floor irradiation, mild to moderate symptoms (leakage of less than 300 g/24 h), absence of history of urethral stricture and good residual sphincter function (checked by the repositioning test). It is however important to state that these factors are not fully consensual and are mostly based on single centre experience.
The AdVance™ male sling has been studied in multiple prospective cohort studies. Mean success rate (no pad use) at medium-term follow-up (around 3 years) is about 60 %. Usually, an additional proportion of patients is improved, and 20–25 % failed. Major complications are exceptional; minor complications occur in 5–15 % of cases and include transient urinary retention, haematoma, perineal pain, urinary tract infection, neurapraxia and superficial wound infection. In the vast majority of cases, these minor complications resolved spontaneously (Table 6.1).
Table 6.1
Data from the literature related to efficacy and complication following the implantation of AdVance™ male sling
Authors | N | F-up (months) | Definition of success | Success | Improved | Failed | Major complications | Minor complications |
|---|---|---|---|---|---|---|---|---|
Gozzi (2008) | 67 | 3 | No pad | 52 % | 38 % | 10 % | None | Transient AUR (16.4 %) |
Davies (2010) | 13 | 6 | 0 or 1 pad | 85 % | – | 15 % | None | Transient AUR (15 %) |
De novo OAB (7 %) | ||||||||
Gill (2010) | 33 | 8.2 ± 17.9 | No pad | 51 % | 20 % | 29 % | None | Transient AUR (9 %) |
Rash (3 %) | ||||||||
Cornel (2009) | 33 | 12 | No pad and pad test <2 g | 9 % | 46 % | 37 % | 1 infection | Transient AUR (3 %) |
Rehder (2010) | 118 | 12 | No pad | 74 % | 17 % | 9 % | None | Transient perineal pain (19.5 %), transient AUR (5 %) |
Groin pain (2 %) | ||||||||
Cornu (2011) | 136 | 21 ± 6 (12–36) | No pad | 62 % | 16 % | 22 % | None | Transient voiding difficulties (14 %) |
Haematoma (1 %) | ||||||||
Transient perineal pain (12 %) | ||||||||
Bauer (2011) | 126 | 27 (20–37) | No pad or security pad | 52 % | 24 % | 25 % | 2 explantations | Transient AUR (15 %) |
Transient perineal pain (1 %) | ||||||||
Rehder Eur Urol (2012)* | 156 | 39 (37–4) | No pad or security pad | 53 % | 23 % | 23 % | 1 explantation | Transient perineal pain (50 %) |
Transient AUR (9.6 %) | ||||||||
Dysuria (4.5 %) | ||||||||
Haematoma (3.2 %) | ||||||||
UTI (<1 %) | ||||||||
OAB (<1 %) | ||||||||
Superficial wound infection (<1 %) | ||||||||
Suskind (2012) | 36 | 19 (1–40) | No pad | 38 % | 42 % | 20 % | NA | NA |
Mueller ISRN Urol (2012) | 32 | 9 (3–14) | No pad | 56 % | 22 % | 22 % | 1 explantation | Transient AUR (15.6 %) |
Li J Urol (2012) | 56 | 24 (17–28) | No pad | 39 % | 23 % | 38 % | None | Rash (3 %) |
Transient AUR (11 %) | ||||||||
Berger (2012) | 26 | 12 | No pad | 62 % | 27 % | 11 % | None | Transient AUR (35 %) |
Transient perineal pain (19 %) | ||||||||
Kowalik (2015) | 30 | 39 (36–44) | No pad or security pad | 60 % | 13 % | 27 % | None | Transient AUR (30 %) |
Wound infection (3 %) | ||||||||
Neurapraxia (3 %) | ||||||||
Chronic pain (6 %) | ||||||||
Collado Serra (2013) | 61 | 26 (12–53) | No pad use | 80 % | 0 | 20 % | None | Transient AUR (15 %) |
Haematoma (4 %) | ||||||||
Neurapraxia (10 %) | ||||||||
OAB (10 %) |
The Argus™ male sling has been evaluated through a limited number of cohort studies. Efficacy has been stated variable in the literature, between 17 and 79 % of patient being cured. The rate of complications has been shown to be quite high with a lot of cases of explantation. Other complications included transient retention, bladder or urethral injury, OAB, haematomas, perineal pain, wound infections and urinary tract infections (Table 6.2).
Table 6.2
Data from the literature related to efficacy and complication following the implantation of Argus™ male sling
Reference | N | Median follow-up (months) | Definition of success | Cured | Improved | Failed | Revisions | Major complications | Minor complications |
|---|---|---|---|---|---|---|---|---|---|
Bochove-Overgaauw | 100 | 27 [14–57] | No pad use or security pad | 38 % | 30 % | 32 % | 32 % | Urethral stenosis (12 %) Explantation (11 %) | Transient retention (16 %) Bladder injury (6 %) Transient pain (11 %) OAB (1 %) Haematoma (1 %) Wound infection (6 %) UTIs 2 % |
Romano | 48 | 45 [36–54] | No pad use | 66 % | 13 % | 21 % | >11 % | Explantations (19 %) | Perineal pain (4 %) Transient retention (15 %) Urethral perforation (6 %) Transient dysuria (21 %) |
Hubner | 101 | 28 | 20-min pad test of 0–1 g | 79 % | ND | ND | 39 % | Explantation (16 %) < div class='tao-gold-member'>
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