Hypothesis / aims of study
Post Prostatectomy Urinary Incontinence (PPUI) is the most devasting complication of Prostatic Surgery regardless if it occurs for the treatment of benign prostate hyperplasia or prostate cancer. PPUI is very common in the early postoperative period and many patients will recover continence over the time. However, if the patient remains incontinent after one year is very unlike, he recovers continence. The hydraulic artificial sphincter AUS 800 is considered the gold standard treatment for this PPUI. Although the AUS presents elevated levels of continence and patient satisfaction its durability over the time has been questioned by some authors. One on the causes for its lack of efficacy can be some degree of urethral atrophy and/or erosion of the bulbous urethra due to excessive compression of the sphincter cuff compromising its blood supply. The adjustable sphincter Victo® is also a hydraulic system that works based in urethral compression. However, this device has a titanium port (figure 1) that allows saline injection or removal in the system by percutaneous thin need punction of the pump through the scrotum skin. This unique characteristic allows activation of the sphincter by the injection of 4 cc of saline in the 40o postoperative day and further weekly injections of 1-2 cc of saline in order obtains continence with the minimal system volume and thus the minimal cuff pressure in the postoperative period. This progressive adjustment may allow preservation of urethral flow and avoid urethral atrophy and erosion. This low-pressure urethral compression may be very important to preserve specially in patients with frail urethra secondary to radiation therapy and/or previous urethral or anti incontinence procedures. The adjustable device also permits long term adjustments in an attempt to recovery of continence in some patients by increasing the system volume and thus the pressure around the urethra. In this multicentrically Prospective study, we evaluate the efficacy and safety of the adjustable urinary sphincter Victo® for the treatment of Post Prostatectomy Urinary Incontinence (PPUI)
Study design, materials and methods
The Study was Approved by the Ethics Comite and was held in four reference centers for the treatment of PPUI. In order to minimize the learning curve all, the urologists involved in the study have good experience with AUS 800 sphincter placement. After signing the informed consent 34 patients suffering from Post prostatectomy urinary Incontinence (PPUI) underwent Victo® sphincter placement. From the 34 patients 7 patients had PPUI secondary to surgical treatment of benign prostat hyperplasia and 27 aecondary to radical prostatectomy. From the 27 (79,4%) patients suffering of prostate cancer 12 underwent open, 12 laparoscopic and 3 robot assisted radical prostatectomy.
In our group of 34 patients 13 (38%) had previous radiation therapy and 6 patients were under androgen deprivation therapy by the time of sphincter implantation. Three patients (9%) had previous incontinence surgery (Slings) and 5 (15%) urethral strictures treated by previous internal urethrotomy. Patients age ranged from 56 to 83 years (mean= 69,11). The interval between prostatectomy and Victo® placement was superior to one year in all patients. All of had sphincter deficiency diagnosed by urodynamic evaluation and 7 (21%) had associated bladder overactivity.
Preoperative pad count varied from 2 to 11 (mean = 5,14). In fact, only one patient (3%) was wearing two pads a day, 5 (15%) required 3 pads/day, 9 (26%) were wearing 4 pads/day, 11 (32%) wearing 5, 5 (15%) wearing 6 pads/day. Just, one patient (3%) referred 8 and another one (3%) 9 pads/day in order to contain urine. International Consultation on Incontinence Questionnaire - We have used a visual analog scale (VAS) to evaluate the impact of incontinence in patients quality of life (QoL). The scale ranged from one to five whe one was considered a very good QoL and 5 a very bad QoL. Many authors have demonstrated a good correlation between the use o an anlogic scale and specific QoL questionaires. Pre operative scale evaluation ranged from 3 - 5 (mean= 4,38).
All patients underwent Victo® implantantion under general anesthesia and were placed in a lithotomy position. A perineal incision was made for bulbous urethra dissection and measurement. The whole system (figure 2) was inserted through a transverse lateral abdominal. The reservoir was preferentially placed inside the peritoneum and the pump was placed into the scrotum in the subdartous space. In all the patients the system was filled with an initial volume of 13 cc of saline in order to remove all the air of the components.
Patients were kept during 24 hours with a Foley catheter. They were discharged in the first postoperative without the catheter after presenting significant urine leakage
Follow up included early and late complications. A Clavien Dindo Scale was used to classify surgical complications.
Besides the safety of the procedures the main endpoints were reduction in the number of pads/days to contain urine as well as Improvement in quality of life. QoL scores and reduction in daily pads were compared to baseline using the T of Student test for paired values.
Results
The time between prostatectomy and sphincter implantation was superior to one year in all patients.
Follow up ranged from 1 – 26 months (mean= 14,85 months)
Cuff size varied from 3,7 to 5 centimeters (mean= 4,16 cm)
The reservoir was placed inside peritoneum cavity in 32 patients and in preperitoneal space in 2 with bowel adherences.
Sphincter activation was under outpatient basis after 5 to 8 weeks (mean 5,5 weeks). Initial volume for activation was 4 cc in all patients. Final injected volume required for continence varied from 4 to 10 cc (mean= 5,8 ml). In 10 patients just one 4cc injection was required to reach continence.
Currently 32 sphincters are activated, one was removed due to erosion and one wait activation. One sphincter was replaced due to pump malfunction and one additional surgery was made due to pump misposition without system exchange.
In the last follow up from the 32 patients with the sphincter in place 8 (24%) are completely dry, 20 (59%) requires one pad a day performing a total of 28 (83%) patients who archived social continence. Four patients (12%) have more than 50% improvement and are wearing 2 pads a day.
Overall dayly pad count reduced from 5,14 to 0,857 (p<0,05).
All the patients who became socially continents referred a significant improvement in QoL Post operative visual scale evaluation in the 32 patients with a functioning sphincter ranged from 1-3 (mean= 1,25) (p<0,05)
Besides the cases of erosion, pump malfunction and pump mispositioning we had some minor’s adverse events like local pain and hematoma in tow patients. treated conservatively. We did not have any urethral erosion even in patients with radiation therapy and previous surgery. We did not have any major Clavien Dindo surgical complications.
Interpretation of results
The Victor® sphincter can be considering a good alternative for the treatment of PPUI. The initial results suggests that it can be a good alternative even in patients with radiation therapy or previous urethrotomy or anti incontinence procedures. The procedure seems to be minimal invasive and not accompanied by major clinical complications even in elderly patients