Fig. 1
MRS components and way of detachment
As with any prosthetic surgery, antibacterial measures should be taken such as correct shaving both the suprapubic area and the perineum and cleaning both areas for 2–3 min with povidone-iodine. Prophylaxis with broad-spectrum antibiotic will start 1 h before surgery and maintained while the manipulator is attached to the varitensor. Under spinal anesthesia, the patient is placed in lithotomy position, and the usual sterile field protections are placed.
An 18 ch Foley urethral catheter is placed to completely empty the bladder and to easily locate the bulbar urethra by palpation during surgery. Then we make a sagittal perineal incision about 5 cm above the bulbar urethra and briefly dissect the subcutaneous tissues to locate the bulb cavernous muscle (Fig. 2a). Bilateral dissection of the paraurethral tissues is performed toward the middle of isquiopubian branch approximately at the level of the angle between muscle bulbocavernous bulb and ischiocavernosus muscles. Then, the fascia is perforated just at the lower edge of the bone by blunt dissection to reach the endopelvic fascia. This fascia must also be dissected to access the retropubic area with the index finger.
Fig. 2
Surgical steps to place a MRS
Then, we start the suprapubic preparation by performing a 4 cm transversal incision just 2 cm above the pubis (Fig. 2b). Adipose tissue is dissected until a clear exposition of the fascia of the anterior abdominal rectus muscles (or the previous surgery scar after open prostatectomy) upon which we will place the REMEEX™ prosthesis.
We return to the perineum and cut the perineal body or central tendon of the perineum (Fig. 2b). This maneuver is essential to reposition the sphincter complex in a more intra-abdominal position. Then we introduce the thread passer, part of the set, with the tip guided by the index finger until we reach the reached the retropubic space (Fig. 2c). Then remove the finger, and push the needle toward the ipsilateral shoulder of the patient in the most upright possible in contact with the inner face of the pubis to avoid inadvertent puncture of the bladder. Slowly we move forward until the tip of the needle appears through the suprapubic incision (Fig. 2d). The same maneuver is repeated on the contralateral side. We then perform a cystoscopy to check the bladder integrity.
We introduce the ends of the polypropylene traction threads through the holes in the distal part of the needle and push the needle all the way up to the abdominal incision. We then fix the tip of the traction threads with a mosquito at the abdominal site.
The maneuver is repeated on the contralateral side, and we then position the suburethral mesh under the bulbar urethra by pulling the tips of both traction threads (Fig. 2d, e). We fix the mesh under the bulbar urethra by two absorbable sutures (Fig. 2f, g). We complete the perineal time by checking hemostasis and closing by planes leaving an incision drainage.
In the suprapubic area, the tips of the traction threads are passed through the lateral reception holes of the REMEEX™ prosthesis. Keeping the prosthesis in the midline, and about 10 cm above the fascia of the rectus (about four finger tips), will fix the traction threads by screwing the central fixation screw.
We rotate clockwise the manipulator, to wind the traction thread into the varitensor until the varitensor rest over the rectus fascia with no tension (Fig. 2h). We then finish the intervention by closing the abdominal incision in layers and covering the manipulator with gauze so that it rest perpendicular to the abdominal wall.
If no complications occurred during surgery and no hematuria, we start the urethral support adjustment 24 or 48 h after the operation. To do the adjustment, we fill the bladder through a catheter with 250–300 mL of saline. Ask the patient to stand up, and begin to rotate the manipulator clockwise, until we get urinary continence in resting phase (Fig. 3b).
Fig. 3
Readjusting suburethral mesh tension of the MRS (With permission to be published from Neomedic Int.)
At first, you may have to give many turns to the manipulator to reach continence at rest.
Once the patient is continent at rest, we invite him to cough, to perform Valsalva maneuver (defecation type) or those that usually produce losses of urine (such as squatting). If the patient leaks, we turned the manipulator four complete turns and check again the continence. The maneuver is repeated as often as necessary until complete continence under stress (Fig. 3c) is achieved.
Then will then check that the patient is able to urinate without difficulty and that the amount of residual urine is less than 100 mL. If the patient is unable to urinate properly, it is preferable to slightly loosen the varitensor even at the cost of having some small urine loss. At that time, we can remove the REMEEX™ manipulator using the disconnector.
In cases where there was minima bladder perforation (punction) or urethral manipulation during the operation had caused hematuria, we should leave the manipulator in place, and adjustment can be delayed 1 or 2 days. Oral administration of cloxacillin 500 every 8 h during those days helps prevent infection of the prosthesis by Gram + cocci present on the skin.
Most patients will leave the hospital with full continence or with minor losses. However, a significant proportion of patients have recurrence of urinary incontinence that can sometimes be significant. This is because the urethral edema and the inflammation at the surgical site help to achieve continence just after surgery, but once disappears, urethral closing pressure may decrease to values under the hydrostatic pressure of the bladder at stress (or even at rest) thereby reappearing incontinence.
In these cases, we must make a late readjustment. To perform it, we make a small incision, under local anesthesia, through the previous suprapubic wound and dissect the anterior surface of the prosthesis. The manipulator is reconnected to the REMEEX™ prosthesis using the disconnector, and we can repeat the adjustment procedure explained in the preceding paragraphs. Usually, dissection is simple, and the whole procedure including wound closure typically takes less than 5 min.
The long-term readjustment of the suburethral support can be done under local anesthesia without any difficulty at any time during patient lifetime. Both traction threads and the REMEEX™ protheses are encapsulated allowing mobilization and modification of the traction threads and thus the sling urethral support level whenever needed.
Results
Between November 2001 and May 2015, 48 patients have been surgically treated with a Male Remeex System at the Comarcal Hospital of Monforte. Mean age of the group was 69 years (range between 56 and 82 years). Origin of the incontinence was radical prostatectomy in 42 patients (87.5%), retropubic adenomectomy in 2 cases (4.2%), and prostatic transurethral resection in other 2 (4.2%).
Grade of urinary incontinence was mild (1–2 pads/day) in 11 patients (23%), moderate (3–4 pads/day) in 24 (50%), and severe (5 or more pads/day) in 13 (27%). Pure sphincteric incontinency was present in 43 patients (89.6%) and mixed incontinence in 5 cases (10.4%). Four of the patients also presented sclerosis of the vesicourethral anastomosis, and cold internal urethrotomy was done in all cases.
After a medium follow-up of 74 months (range between 11 and 156 months), 26 patients were pad-free (54%), another 14 were improved—pad reduction > 50%—(29%), and 8 patients (17%) were considered failures. Six patients (12.5%) died during the follow-up period due to causes unrelated to the sling. At decease moment, four of them were dry and other two improved.
Unlike nonadjustable procedures, REMEEX™ sling results vary depending on long-term readjustments, and the rates of success may vary because an incontinent patient may always be readjusted to reach continence. In fact, we performed an average of 2.5 readjustments (0–6) to achieve these results.
Among the failures, three of the patients had to be explanted during the follow-up: one for chronic varitensor rejection and one for pain and erosion of the pubic bone after four readjustments. (It has to be said that both patients were reoperated by placing an ATOMS sling and it was also rejected in both patients.) Another patient was explanted by prosthesis infection after the second readjustment. One patient had a right hemiplegia after a CVA, and we decided not to readjust him anymore after two attempts. Finally, two more patients decided to not perform more readjustments after one and three, respectively.
There were one puncture of the urethra and four unilateral and one bilateral punctures of the bladder; these mean a perforation in 7.3% of the 96 retropubic passages of the needles (48 × 2). Five of the perforations were done among the first 20 patients being related to the learning curve. There was only one perforation in the following 24 cases. All punctures were uneventful except for mild hematuria. However, these six patients couldn’t be readjusted during the immediate post-op period. One patient had enough pain to ask for prosthesis explantation and other four referred very mild pain which was easily controlled with common analgesics after 7–28 days of treatment.
It is important to mention that no patient presented acute urinary retention at any moment after the surgery and all patients had postvoiding residues below 100 mL.
Discussion
Stress incontinence is bothersome postoperative late complication after radical prostatectomy and produces a significant deterioration in the quality of life of patients who suffer it. The term intrinsic sphincter deficiency does not fully describe the complexity of the pathophysiology of male urinary incontinence after prostate surgery.
Prostatic surgery may damage supporting fascias of the sphincter complex, decreasing the muscle mass of both striated and smooth sphincters, and it may injure sphincter and pelvic floor innervation. The main cause of incontinence is the direct injury of the sphincteric muscle complex. In other cases, it is due to the laxity of the sphincter complex support and/or dislocation of the sphincter complex, through pelvic floor, that it cannot maintain the urethral lumen closed, resulting in urinary leakage. The highest degree of urethral sphincter prolapse in incontinent males is at the posterior area of the sphincteric urethra, and its correction may cure incontinence [15–18].
Moreover, the quality of the urethral wall is vital for the pressure transmission in order to achieve coaptation of the urethral mucosa. The functional urethral length has to be greater than 15 mm to restore continence. Finally, bladder dysfunction is a key to optimize treatment outcomes and to avoid unnecessary operations. The compliance and detrusor contractility are two fundamental variables when considering the surgical treatment of incontinence [19].
Despite all the advances that have occurred in the study and treatment of postprostatectomy incontinence, the truth is that we still do not know which of the possible causal factors are responsible for the male urinary incontinence in a particular case and which is the best technique to treat the patient.
Bladder dysfunction should be analyzed before treatment of urinary incontinence. Sphincter dysfunction can differentiate into “intrinsic” when there is a failure of the sphincter muscle and “hypermobility” when the sphincter complex is in the wrong anatomical position. An individual patient could have one or both forms of sphincter dysfunction [16, 17, 20].
The New York Presbyterian Hospital group [15] proposed that when anatomical position is not restored, some hydraulic forces act against the internal sphincter function complicating urinary continence (Fig. 4).
Fig. 4
Hydraulic forces acting over the urinary sphincteric complex out of place after radical prostatectomy and once replaced to its normal anatomical position (Modified from Srivastava et al. Arch. Esp. Urol. 2012; 65 (5): 529–541) (with permission to be published from Archivos Españoles de Urología)
A patient with bed wetting indicates an ineffective occlusive capacity of the sphincter complex. That sphincter damage needs some kind of compression therapy, and a transobturator sling repositioning will not be enough. Conversely, if a patient is continent in bed but not in standing position, he is more likely to suffer from hypermobility [16].
In a man demonstrating leakage with straining that stops at the cessation of the straining maneuver, the diagnosis of ISD can be made without further testing. A voiding diary is sufficient to demonstrate adequate bladder capacity, and a bladder scan can evaluate the patient’s ability to empty his bladder. However, with regard to bladder contractility, this can only be analyzed by detailed urodynamic evaluation. Given the recent expansion of therapeutic options to treat SUI, a thorough evaluation should also include pad weight and urodynamic studies—to best indicate a specific surgical therapy [16, 17, 20].
Treatment options are multiple and include low-invasive surgical interventions to increase urethral closure pressure up to the point continence while maintaining a physiological urination. These therapies are very attractive procedures. Within this group is periurethral injection of bulking agents. Although it is a minimally invasive procedure, they get very poor results (8–36% at two 2 years follow-up). The need for reinjection increasing the treatment cost is very frequent [21, 22]. A more effective variant of this principle is the adjustable periurethral balloons that allow refilling or emptying by puncturing the subcutaneous port available. However, its clinical success depend on surgeons experience. Complication rate, such as urinary tract erosions, may reach 20% of patients and in exceptional cases rectal perforation during may occur [23].
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