Since radical prostatectomy has become more common, male urinary incontinence was seen more common too at recent years. There are different equipments and techniques for treatment of urinary incontinence.  Bladder neck injection of bulking agents, balloon implantation to periurethral space, male sling operations and artificial urinary sphincter implantation are common methods for treating urinary incontinence. Although many methods have been described until today, there are some handicaps with each of them such as infection, urethral erosion, serious pain, inefficiency and technical difficulties of operations. We described a new device named Turkish Continence Device (TCD) which had some advantage over the other methods. The aim of this study to experiment the prototype of TCD in vivo and ex vivo in term of its efficiency, convenience of implantation and negative effects.

We used 3 male goats and 3 male sheep for the study. Before the study for elaborating anatomy of the animals, we made cadaveric dissection on penis and urethra of these species.  After that we excised the urethra and penis as a block. Proximal urethra has been chosen for modelling and measuring the urethral pressure produced by TCD. We studied urethral closure pressures on the apparatus which consist of excised penis-urethra specimen and prototype device implanted on it. We created the apparatus by placing prototype device on the proximal urethra by suturing to lateral surfaces of tunica albuginea of cavernosal bodies bilaterally with two sutures on each sides (Fig. 1).   Prototype of novel devices includes a Foley catheter (6F or 8F) covered all around with prolen mesh. Not to displace the Foley balloon on urethra, the mesh leaves were braided by prolen stitches around the Foley balloon. Two prolen wings were left bilaterally to fix the device by suturing on cavernosal body's tunica (Fig. 1).  After that  we inflated the Foley balloon with saline (0.3-1.5 ml) until making it stretched. We inserted a Nelaton sonde from distal incision of urethra and Nelaton catheter was connected to saline bag via a serum set to measure the urethral pressure produced by external compression of TCD model. When maximal stretch of the balloon inflated, flowing of fluid from saline bag is stopped. Then we shrank the balloon gradually and measured urethral closure pressure (UCP) repeatedly for each volume. 
After postmortem examination of animals, we made implantion of the novel prototyp devices in live animal model. We operated three male sheep and three male goats under general anesthesia.
We implanted TCD prototypes on posterior urethra by fixing it tunica albugnea of cavernosal bodies on each lateral side at all the animals. Foley catheter's opposite side has two tips which one is for balloon inflation/deflation and the other is for urine drenage. We cut the tab of urine drainage channel to facilitate the catheter passing inner scrotal wall and getting out of an incision on lateral scrotal wall. We purposed to inflate/deflate the balloon from this tip to arrange urethral pressure after operation. Implantation of device and getting Foley sond's inflating/deflating channel tip out of the body we finished operation closing urethrostomy and skin incision. 
We inflated the Foley balloon with 0.3-1.5 ml saline according to streching it very tightly. After closing the incision all animals were clothed to check wetting with urine. We wondered if the animals would urinate or not. We injected diuretic (frocemid 2 mg/kg) to observe the results quickly.
On the 7th day, a ram and a goat were underwent imaging study to evaluate the degree and effect of urethral obstruction. We made intravenous nephro-pyelography and retrograde urethrography.
We fed all the animals for 1 month and then sacrified them. We excised postrior urethra including implanted TCD prototype for pathologic investigation.

After insertion of Nelaton catheter to urethra with prototype device complex (apparatus 1), we measured  UCP.  We saw that a little volume was enough to obtain efficient urethral closure pressure. The necessary balloon volume for efficient UCP is under 1 ml which shows that continence would be achieved in incontinent men by useing  very small devices. We repeated this measurement procedure on apparatus 2 and gave all UCP values at different volumes of Foley balloon at table 1.
  
Table 1 shows UCPs at different volumes in the baloon  on aparatus 1 and 2
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  	                                                                                       Apparatus 1                                         Apparatus 2
 Saline volume in the baloon (ml)              Urethral closure pressure (cmH2O)	     Urethral closure pressure (cmH2O)
___________________________________________________________________________________________________________________________
                 1.5 ml	                                                                    160	                                                       145
                 1.2 ml	                                                                    115	                                                        95
                 0.9 ml	                                                                     88	                                                        65
                 0.6 ml	                                                                     56	                                                        34
                 0.3 ml	                                                                     28	                                                        16
                    0 ml	                                                                     12	                                                        10
___________________________________________________________________________________________________________________________

We decided that TCD prototype didn't cause complete obstruction because the clothes on all  animals got wet.
We couldn't estabilish any pathology at renal and vesicourethral images. When we sacrified the animals and checked balloons of the Foley catheters we saw that they were shrunk due to fluid leakage because of high pressure on it. Macroscopically prolene mesh was embeded in surrounding tissues of urethra. It was dissected and urethral wall was isolated.  There were not any findings of urethral erosion or damage because of prolene mesh (Fig. 2). Microscopic examination confirmed these findings  that there were not any pathologic changes in urethra and corpus spongiosum.

There have been defined many equipments and techniques for treatment of urinary incontinence. These are various artificial urinary sphincters, tandem cuffs technique, transcorporal cuff technique, remotely-controlled sphincter, the tape mechanical occlusive device, electromechanical artificial urinary sphincter, periurethral constrictor (PUC) device, various male sling procedures (1).  But none of them is completely efficient since there are some handicaps with each of them such as infection, urethral erosion, serious pain, inefficiency and technical difficulties of operations.
Transcorporal cuff placement is the only described method that corpus cavernosum serve the purpose of incontinence treatment. In patients with recurrent incontinence secondary to erosion, sub cuff urethral atrophy, inadequate urethral coaptation or for patients undergoing revisions where more proximal placement couldn't be achieved, transcorporal cuff placement may improve continence (2). 
There is a concern that transcorporal cuff placement affect erectile dysfunction. However most patients already have some degree of erectile dysfunction at baseline because of prostate cancer treatment. A small series reported that the majority of patients maintain their erectile function even after transcorporal cuff placement (5/6, 83%) (3).
 In our study, we also used corpus cavernosum's tunica albugnea for fixing TCD, but our method didn't include dissecting cavernosal body like transcorporal cuff placement. Because of that, it is less invasive than that procedure and we except that it has no effect on erectile function.

Our device (TCD) is much smaller than the others because it doesn't need long mesh tapes or cuff-pump-reservoir unlike  them. It provides sufficent  pressure for continence because of sitting exactly on the urethra. We use cavernosal fascia for holding and fixing TCD instead of passsing the tapes retropubic or transobturator routes.  Because of the reasons of small devices and the least invasive implantation technique, we estimate minimally complications like as pain, infection or urethral erosion. Additionally the surgical procedure is simpler, its learning curve might be shorter and peroperative complications (organ, vessel or nerve injury) might be much less than all other continence devices operations.

Caremel R, Corcos J. Incontinence after radical prostatectomy: Anything new in its management? Can Urol Assoc J.  2014; 8(5-6): 202–212.
Guralnick ML, Miller E, Toh KL, Webster GD. Transcorporal artificial urinary sphincter cuff placement in cases requiring revision for erosion and urethral atrophy. J.Urol. 2002; 167(5): 2075–2078.
Wiedemann L, Cornu JN, Haab E, Peyrat L, Beley S, Cathelineau X, Haab F.. Transcorporal artificial urinary sphincter implantation as a salvage surgical procedure for challenging cases of male stress urinary incontinence: surgical technique and functional outcomes in a contemporary series. BJU. Int. 2013; 112(8): 1163–1168.