Bladder irritants
Coffee
Sugar
Tea
Artificial sweetener
Honey
Chocolate
All alcoholic beverages
Tomatoes
Carbonated beverages
Tobacco
Caffeinated sodas
Citrus fruits and juices
Corn syrup
Spicy foods
Obesity is a well-established cause of UI in women and its negative effects on male PPI are becoming better appreciated. A longitudinal epidemiologic study of 6462 women over 40 years old found a strong correlation between BMI and the risk for OAB and SUI [2]. The data has been consistent across the female population. Studies have also shown that obesity in men may be associated with a higher risk for PPI. Wolin et al. found that obese men were significantly more likely to be incontinent at 58 weeks compared to their non-obese counterparts [8]. In fact, van Roermund et al. determined that obese men were more likely to suffer from wound infections, PPI, and vesico-urethral strictures after open radical prostatectomy [9]. Data regarding nonsurgical weight loss as a treatment for UI is limited. Subak et al. randomized 338 overweight and obese women with UI to an intensive 6-month weight loss program or a control structured education program. Women in the treatment group lost an average of 7.8 kg, and the average number of weekly incontinence episodes decreased by 47%. This was significant when compared to the control group that had a mean weight loss of 1.5 kg and only a 28% reduction in incontinence episodes [10]. Given the overall health benefits, general guidelines for physical exercise, weight loss, and healthy diet are reasonable recommendations for the treatment of PPI.
Smoking is associated with an increased risk of obesity and been studied in the past as a possible contributor to the development of UI symptoms. However, the ICI suggests that, due to the conflicting data between cross-sectional studies and longitudinal studies, smoking is most likely not a risk factor for UI. There are currently no studies supporting smoking cessation for PPI, but it should be recommended for general health [5].
Behavioral Training
While preoperative behavioral training has been shown to significantly decrease the time to continence after radical prostatectomy, postsurgical rehabilitation has been studied with mixed results [11]. Because the definition and quantification of incontinence, the timing of the evaluation relative to the surgery, and whether the physician or patient evaluates the presence or absence of incontinence vary between studies, there is currently an insufficient amount of adequately powered randomized controlled trials (RCTs) that show conclusive results [12]. Nevertheless, Goode et al. found that 8 weeks of behavioral therapy resulted in fewer incontinence episodes when compared to a delayed-treatment control [13]. Additionally, behavioral therapies are inexpensive and low-risk options that can be used in conjunction with one another and other conservative techniques. Several common behavioral therapy techniques are discussed below.
Pelvic Floor Muscle Training
Pelvic floor muscle training (PFMT) is the most studied conservative treatment for PPI, and studies have shown varied success. PFMT is the intermittent, voluntary contraction of the urethral sphincter muscles to strengthen the pelvic floor and increase control over unexpected urine loss. Strengthening the pelvic floor muscles may inhibit detrusor activity and increase muscle efficiency during increased intra-abdominal pressure [12]. PFMT may also increase the “external mechanical pressure” on the urethra by hypertrophying the periurethral striated muscles [14]. PFMT is often taught by a physiotherapist, requires little to no equipment, and can be performed in a home or office setting. The 2016 European Association of Urology (EAU) guidelines advise that instruction for PFMT should be offered to all men undergoing RP to speed up recovery of postoperative continence [15].
Several RCTs have shown that men who perform PFMT preoperatively significantly decrease the duration and degree of incontinence at 3 months postoperatively compared to men who do not perform the exercises. In a meta-analysis conducted by Fernandez et al. [16] of eight RCTs, four trials compared PFMT to controls with no physiotherapy [13, 17–19], and four compared PFMT sessions at home versus under professional supervision [20–23]. The authors concluded that PFMT programs with ten repetitions three times daily increase the rate of continence, as PFMT was shown to improve the continence rate in the short, medium, and long term [13, 16–19]. No benefit was found to therapist-led PFMT compared to at home PFMT [20–23], and several of the studies did not find a difference in continence at 12 months’ post-surgery [18–19]. All of the studies looked at the perioperative period, and the authors cited limitations due to the variance of PFMT and the heterogeneity of the population.
However, another meta-analysis by Wang et al. published contradicting results, suggesting that preoperative PFMT did not improve UI after RP at any time period [24]. Geraerts et al. performed an RCT of 180 patients that found no significant difference in the duration of PPI between patients that started PFMT 3 weeks before RP or postoperatively [25].
Nevertheless, there is level one evidence that, prior to offering invasive therapy, all patients should receive PFMT [15]. It is the authors’ opinion that PFMT is an inexpensive and noninvasive therapy that can prevent and alleviate PPI after surgery.
Biofeedback
Biofeedback is often used in conjunction with pelvic floor exercises using auditory or visual cues, called functional PFMT. By bringing attention to the muscle and providing cues, the therapist seeks to train the patient how to gain control of and strengthen the pelvic floor muscles. The therapist can indicate a contraction to the patient during DRE; although more sophisticated electronic methods exist, they have not proven to be superior [7, 11]. A review by MacDonald et al. found that PFMT with or without biofeedback decreases the time to continence, questioning the utility and efficacy of adding biofeedback to PFMT [26]. Goode et al. found no benefit to adding biofeedback and electrical stimulation to PFMT in a study of 208 patients randomized to PFMT and behavioral training, PFMT with biofeedback and electrical stimulation, or control [13]. The ICI gave a grade B recommendation for the use of biofeedback, deferring to therapist preference and individual economics [5].
Electrical Stimulation (ES)
Biofeedback in the form of electrical cues can also be utilized. Electrical stimulation (ES) delivers small electrical currents via surface electrodes to stimulate the pelvic floor muscles to contract. Pelvic floor muscle contractions cause the bladder to contract, closing the sphincter to prevent urine flow and thus decreasing leakage. Anal electrodes or less invasive patch electrodes in the perianal or posterior tibial nerve distribution can be used (Fig. 1). Like literature on PFMT, the literature on the efficacy of PFMT with ES or other biofeedback mechanisms varies widely. Mariotti et al. demonstrated that pelvic floor electrical stimulation, in addition to biofeedback, hastens the time to urinary continence both 7 days after catheter removal and 12 months after RP [27, 28]. Likewise, after RP, PFMT with active stimulation of 50 Hz square waves of 300 μs pulse duration for 15 min twice daily in a 5 s on, 5 s off duty cycle using an anal electrode was found to significantly decrease the time to continence recovery [29].
Fig. 1
Electrical stimulation device with probe
However, Wille et al. found ES-enhanced PFMT did not affect continence. Instead, the authors asserted that omitting biofeedback and ES from PFMT was as effective and more cost-conscious, saving the patient up to €711 [30]. The 2016 EAU guidelines do not recommend the use of ES alone in the treatment of male SUI [15].
Extracorporeal Magnetic Innervation
Similar to electrical stimulation, extracorporeal magnetic innervation (ExMI) directly stimulates the pelvic floor muscles and sacral roots through pulsing magnets to initiate muscle contraction. Patients sit in a chair that contains a magnetic field generator in the seat. The treatment is painless, there is no probe, and the patient may remain dressed [31]. While a small study of 87 patients by Terzoni et al. found that ExMI reduced urinary leakages more quickly than PFMT, Voorham-van der Zalm et al. found no change in pelvic floor function in a cohort of 65 women and nine men. In fact, there was no statistical differences in the data before or after ExMI treatment in all subgroups [32, 33]. More RTCs are needed to fully assess the efficacy of ExMI as a treatment for PPI; however, this treatment option is inaccessible to many patients because ExMI chairs are not readily available.
Pharmacotherapy
Pharmacological treatments are not a first-line conservative treatment for PPI due to potential side effects and a lack of data supporting efficacy. The pharmacologic understanding of the receptor innervation and activity of the bladder neck, proximal urethra, and external urethral sphincter complex have allowed several non-PPI-approved medications to be explored. The majority of work has been with alpha-adrenergic agonists. Although there are alpha-adrenergic receptors at the bladder neck, several non-approved medications with adrenergic properties have only been found to be effective in patients with minor degrees of incontinence. This medication is generally used to improve bladder outflow obstruction [34]. Pharmacological treatments for UI also include selective serotonin-noradrenalin reuptake inhibitors, antimuscarinics, and phosphodiesterase inhibitors. To date, there are no regulatory-approved medications for PPI.
Alpha-Adrenergic Drugs
Alpha-adrenergic drugs, such as midodrine, phenylpropanolamine, and ephedrine, have been shown to be effective in controlling symptoms of UI in animal models. Tsakiris et al. reviewed studies regarding the three drugs, and, due to mixed study populations of men and women and a small number of patients, any efficacy data regarding the drugs was inconclusive [35]. Although rare, phenylpropanolamine was reported to cause elevated blood pressure, hemorrhagic stroke, palpitations, and cardiac arrhythmias, causing it to be removed from the US market in 2000 [36]. In general, α-adrenergic drugs are not recommended for used for female SUI due to risk of adverse effects and should not be in primary consideration for treating PPI.
Duloxetine
There is limited data on the use of duloxetine for PPI. Duloxetine is a selective serotonin-noradrenalin reuptake inhibitor used for the management of stress incontinence in women. By inhibiting the reuptake of serotonin and noradrenaline in Onuf’s nucleus, the pudendal motor neurons that regulate the urethral striated muscles in Onuf’s nucleus increase activity [37]. While a study by Schlenker et al. found the average daily use of incontinence pads to significantly decrease in patients who took 40 mg of duloxetine twice daily, 30% of study patients complained of severe side effects and discontinued the drug [38]. Alan et al. demonstrated that 60 mg of duloxetine in addition to PFMT significantly increased dryness with zero patients suffering from adverse events [37]. Duloxetine has not been approved for use in men, and there are currently no pharmacological therapies of this type approved for use in men.
Antimuscarinic Drugs
Antimuscarinic drugs are second-line treatment for OAB and therefore may have some effect on men with mixed incontinence. By inhibiting the release of acetylcholine in the muscarinic receptors at nerve endings, several antimuscarinic drugs approved for OAB have demonstrated efficacy in reducing urinary urgency, frequency, and urgency incontinence. However, adverse antimuscarinic effects such as dry mouth, constipation, urinary retention, and cognitive impairment have been observed, particularly in elderly patients. In a multicenter, randomized double-blind study evaluating the efficacy of solifenacin on UI after RP, Bianco et al. found that, while the primary end point of time to urinary continence was not statistically significant, the secondary end points of proportion of subjects who gained continence and mean change from baseline in average daily pad use were statistically significant at the end of treatment. The only side effect described was dry mouth [39].
A prospective, randomized controlled trial by Shim et al. compared the use of an α-adrenergic agonist (midodrine) plus an anticholinergic (solifenacin) versus α-adrenergic agonist only. They found that, although the rate of continence (pad free) at 4 months did not differ between the two groups, patients who took midodrine plus solifenacin had a significantly decreased value of mean weight of daily pads and an increased maximal cystometric capacity. Though not significant, this group also had a slight increase in quality of life scores [40]. Although more RCTs are necessary, anticholinergics may decrease the time to continence following radical prostatectomy and work in conjunction with other conservative therapies to manage PPI.
Phosphodiesterase Inhibitors
Phosphodiesterase (PDE) receptor isoenzymes are distributed throughout the bladder, prostate, and urethra. PDE inhibitors, such as sildenafil, vardenafil, and tadalafil, are commonly used to treat lower urinary tract symptoms in men with benign prostatic hypertrophy (BPH). In the setting of PPI, PDE5 inhibitors in particular are used to reduce bladder overactivity caused by excitation of bladder sensory nerves during filling. By inhibiting these receptors, the muscle tone in the pelvic arteries relaxes and improves blood supply to the urinary structures. Kaiho et al. found initial worsening of symptoms when PDE5 inhibitors were administered immediately after RARP, but improved final continence status when compared to no medication [41]. More RCTs on PDE5 inhibitor use specifically for PPI and OAB are necessary.
Compression Devices (Penile Clamps)
Penile compression devices, or penile clamps, are external mechanical devices that prevent the leakage of urine by compressing the penis. There is a wide selection of penile clamps available on the market, each with unique fit and features, allowing the patient to choose an option that best fits their needs [42]. These devices are inexpensive, simple to use, discreet, and less invasive than condom catheters with leg drainage or additional surgery. To date, none of the devices marketed completely eliminate urine loss when worn at a comfortable pressure but do result in significant decreases on the Incontinence Quality of Life Questionnaires [43].
Penile clamps are best suited for active men who find their leakage is not adequately managed with pads alone. The devices can be used to reduce urine leakage during periods of increased activity and can provide an effective incontinence management routine when paired with other modalities. Pads can be worn in conjunction with a clamp or be worn as a nighttime alternative as the device must be released approximately every 2 hours and is not recommended to be worn while sleeping. Clamps may also reduce urine leakage to an acceptable level for men who use sheaths or body urinals to manage their incontinence.
Penile compression devices must be used with caution due to the risk of tissue damage, edema, urethral erosion, pain, and obstruction [42]. Kalra et al. also reported the possibility that an anterior urethral diverticulum may develop from the use of compression devices [44]. It is imperative that the devices are only used by cognitively competent men with normal penile sensation who are able to release the device every 2 hours. A patient’s physical capabilities should also be taken into account when choosing a clamp. Features such as material, weight, and ease of opening and closing vary with the different types of clamps on the market, allowing men to choose one that works best for their needs.
Clamps should be fitted to the base of the penis. Some clamps are adjustable while others are available in different sizes. A sizing guide is often available to aid in choosing the right fit. Men may find they need to readjust the device throughout the day with changes in activity. Ultimately, trying a variety of models is best to find the clamp that is most comfortable and best fits the patients’ lifestyle.
There is limited efficacy data or comparative data on the various penile compression devices on the market. Moore et al. studied three penile compression devices (U-Tex® Male Adjustable Tension Band, the Bard® Cunningham Clamp, and the C3® Penile Clamp by Personal Medical Corp.) and demonstrated that the Cunningham Clamp is the most effective and preferred device, but it did reduce penile blood flow if clamped too tightly [42]. Table 2 details several of the clamps available on the market today and outlines their unique features.
Table 2
Summary of the various penile clamps available
Clamp name | Description and manufacturer |
|---|---|
Cunningham clamp  | Penis is placed between two foam pads and the hinged clamp is squeezed shut. Inverted V on lower pad compresses urethra to prevent leakage. Adjustable with five ratchet settings. Bard Medical |
C3 Penis Clamp  | Penis is placed in the padded cradle. Ridge compresses the urethra. Fit is adjusted with strap. Personal Medical Corp. |
J Clamp  | The adjustable barrel compresses the bottom of the penis against the frames surrounding the penis to stop urine flow. Contoured upper frame allows for blood flow. Fit, open, and closed is adjusted with the metal leaver. Jackson Medical |
Squeezer™  | Top pads allow for better circulation by compressing on either side of the vasculature and nerves on the top of the penis. Padded lower arm compresses the urethra to stop urine flow. Single latch to close. Adjustable. Life Control |
ActiCuf™ compression pouch  | Padded closure squeezes the penis to control urine flow. Penis tip sits in absorbent pouch which traps excess leakage. Opens and closes by compressing opening. One size. GT Urological |
Bulking Agents
Urethral bulking agents are space-filling materials injected transurethrally into the submucosal bladder neck/proximal urethra to augment the urethral wall. These agents narrow the urethral opening, increasing resistance to urine flow to potentially decrease leakage. The quest for the ideal injectable bulking agent for the treatment of urinary incontinence began as early as the nineteenth century. Initial materials, such as paraffin, mineral oil, morrhuate sodium, and polytetrafluoroethylene (Teflon) paste, were successful but had the untoward morbidities of pulmonary embolism, urethral sloughing, and migration of particles, limiting their clinical adoption and FDA approval [45–47].
The ideal bulking agent would be biocompatible, with little inflammatory or foreign body response. It would not migrate and can maintain its bulking effect over an extended period of time [48]. The components of the injection should remain stable in volume over time and not dissociate or separate. If micropolymers or microcrystals are utilized, the particle spheres should be nonfragile, adherent to host tissue, and uniform with a particle size >100 μm [49, 50]. Such traits would allow for a bulking treatment that is easily injectable and combine long-term efficacy with a high degree of safety and simplicity. A number of bulking agents exist today for the treatment of UI; however, those products developed to date (Table 3) do not necessarily possess all the traits of an “ideal” bulking agent.
Table 3
Products that have been tested as a bulking agent to date
Bulking agent | Market name | Manufacturer | Distributor | Description | Date approved | Currently available |
|---|---|---|---|---|---|---|
Glutaraldehyde cross-linked bovine collagen | Contigen® | Allergan, Inc. | C.R. Bard, Inc. | Bovine dermal collagen used for the treatment of intrinsic sphincter deficiency in men and women | 1993 | Removed from the US market in 2011 |
Silicone macroparticles (polydimethylsiloxane) | Macroplastique® | Cogentix Medical | Cogentix Medical | Textured polydimethylsiloxane macroparticles consists of varying sizes of silicone spheres. | Approved by the FDA for female SUI due to ISD | Yes |
Polyacrylamide hydrogel | Bulkamid® | Contura International | Ethicon, Inc. | A homogenous hydrophilic gel consisting of 2.5% polyacrylamide and 97.5% water, which allows ingrowth and proliferation of blood vessels originating from the periurethral tissue | Granted CE approval in 2003 for treatment of female urinary incontinence | Available in many European countries, the UK, Australia/New Zealand, and South Africa |
Ethylene vinyl alcohol copolymer | Tegress™ | C.R. Bard, Inc. | C.R. Bard, Inc. | Formerly Uryx®, the ethylene vinyl alcohol copolymer dissolved in dimethyl sulfoxide undergoes a phase transformation from a liquid solution to a complex cohesive spongiform mass. | FDA approved 2005 for female SUI | Removed from market in 2007 |
Carbon-coated zirconium beads | Durasphere®/Durasphere® EXP | Carbon Medical Technologies, Inc. | Coloplast | Durasphere™ contains large pyrolytic carbon-coated zirconium oxide beads in a 2.8% β-glucan water-based gel | FDA approved in 1999/2003 for female SUI | Yes |
Dextranomer/hyaluronic copolymer | Solesta® | Q-Med AB | Salix Pharmaceuticals | Solesta consists of dextranomer microspheres of biosynthesized polysaccharides of non-animal origin | Approved by the FDA in 2011 to treat fecal incontinence in patients who have failed conservative therapy | Yes |
Autologous fat, myocytes, fibroblasts | – | – | – | The use should be discouraged due to the risk of systemic embolization and death | – | No |
Calcium hydroxylapatite | Coaptite® | BioForm Medical, Inc. | Boston Scientific | Synthetic non-immunogenic analog to the calcium hydroxyapatite found in bone and teeth. Detectable on ultrasound or plain film radiography | FDA approved in 2005 for soft tissue augmentation in the treatment of SUI due to ISD in adult females | No |
Polytetrafluoroethylene | Teflon | – | – | The injectable paste is quickly absorbed by tissues and is non-carcinogenic and chemically inert | – | No |
Proper evaluation and selection of candidates for bulking agent therapy is critical for optimal outcomes. Transurethral bulking agents are contraindicated in the setting of pure urge incontinence or bladder outlet obstruction. A male patient with mixed incontinence (i.e., stress and urge urinary incontinence) in whom a predominant urge component exists should ideally address the overactive bladder associated with urge incontinence prior to treating the stress incontinence component. Additionally, men should not receive injectable therapy if there is an active urinary tract infection, and precautions should be taken for patients with bacterial colonization of the urinary tract due to the risk of abscess formation and potential for sepsis. To mitigate these issues, a preoperative urine culture should be obtained, and a prophylactic antibiotic is given prior to the procedure.
In men, the supra-membranous urethral integrity should be assessed with a pre-procedure cystoscopy. Bulking agent therapy is ineffective when placed in scar tissue as the non-pliable tissue will not allow expansion with the bulking agent. Consequently, bulking agents are not recommended in men who have bladder neck contractures, and their use in men who have received previous radiation therapy is cautioned [48]. Because pliable tissue integrity is imperative, men with stress incontinence after a transurethral prostatectomy fair better with bulking agent therapy than men after radical prostatectomy [51]. Overall bulking agent therapy may be considered in properly selected post-prostatectomy incontinent males with stress predominant urinary incontinence, normal bladder capacity, normal bladder compliance, and normal anatomical urethral integrity.
Bulking agent therapy is a minimally invasive procedure that can be performed in the office setting. However, due to the low efficacy rates, lack of durability, need for repeat treatments, and problems with some of the synthetic injectable agents, bulking agent therapy for male PPI is being performed less frequently in current practice than it has been in the past. In fact, with the discontinuation of glutaraldehyde cross-linked collagen (GAX-collagen) in 2011, there is currently no US Food and Drug Administration (FDA)-marketed bulking agent approved for male stress urinary incontinence [52].
Injection Techniques
Bulking agents are injected endoscopically into the male supra-membranous urethra via either a retrograde or antegrade route. Most retrograde injections are performed with the patient under local anesthesia in the office, while antegrade procedures are often in the operating room under anesthesia. Both injection techniques require careful sterile preparation and draping and often local anesthesia with 2% lidocaine jelly placed in the urethra. All patients should receive prophylactic antibiotics prior to injection according to urological guidelines on cystoscopic procedures [53, 54].
Retrograde Injection
In lithotomy position, a 0° or 30° injection cystoscope is utilized to place the bulking agent under direct cystoscopic vision. The bulking agents are injected endoscopically into the urethra superior to the external sphincter to be effective due to limited pliability of the bulbar urethra when injected below the sphincter and potential for sphincter spasm or failure when injected into the external sphincter. At the time of injection, it is important to inspect the pliability of the tissue and ensure proper depth of injection so that the injected bulking agent closes the urethral lumen by deforming the urethral mucosa [48]. However, because the post-prostatectomy urethra is often scarred, the retrograde method can be more difficult and require multiple injection sites. The goal of the treatment is to obtain circumferential coaptation and closure of the urethra. Upon removing the needle from the injection, some extrusion of material is possible. To minimize the loss of bulking material from extrusion, one can either utilize a saline flush of the material or keep the needle in place for an additional 30–60 seconds after the injection is completed. If significant extravasation of bulking material occurs during the injection procedure, the procedure should be aborted and rescheduled, or alternative surgical treatments should be considered [48].
Antegrade Injection
Due to the challenges of retrograde bulking agent injection in post-radical prostatectomy male patients who often have anastomotic scar plate formation, an alternative suprapubic antegrade injection procedure was described by Wainstein and Klutke in 1997 [55]. Under regional or general anesthesia, the patient is placed in lithotomy position. Cystourethroscopy is carried out allowing the bladder to fill to capacity. Suprapubic needle/trocar cystotomy allows placement of two guidewires (one safety and one working) in the bladder. Once the guidewires are in position, the tract is dilated over the working guidewire to allow a 16 Fr sheath to be placed. The injection procedure is often performed with a flexible cystoscope placing the bulking agent submucosally at the bladder neck area. Once circumferential coaptation of the bladder neck is obtained, a small temporary suprapubic tube is placed until adequate voiding is confirmed. Although more invasive, this antegrade technique offers an improved view of the bladder neck and proximal urethra and provides unscarred tissue for the injection, resulting in fewer injection sites.
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