Study design, materials and methods
In this observational single center study, patients were eligible if persistent stress incontinence was present ≥12 months after radical prostatectomy. Measurements preoperatively included 24h frequency volume micturition list, 24h pad test, 24h pad count and quality of life questionnaires. Argus-T adjustable sling was placed with a single perineal route incision approach as described earlier. In short, a seven cm median perineal incision, one cm cranial of the anus, was made with patient in dorsal lithothomy position. After dissecting subcutaneous fatty tissue, the musculus bulbospongiosum was reached and the top of the triangle between corpus spongiosum and corpus cavernosum was identified. Retrograde leak point pressure (RLPP) was measured. One cm below and lateral to the insertion of the adductor longus tendon the medial border of the obturator foramen was identified and the lower arch of the os pubis was reached through the perineal incision. The needle was guided from just above the lower arch of the os pubis to the finger tip of the urologist, which was in the top of the triangle between corpus spongiosum and corpus cavernosum. After tacking the column of the Argus-T, the column was pulled to the inguinal area left and right. The silicone cushion of the Argus-T was positioned around the bulbair urethra. On both sides a silicone ring was placed over the conud columns and positioned on the fascia m obduratorius interna and externa. Again LPP was measured and the tension was adjusted to achieve an increase of RLPP of 10-20 cm H2O. The silicone columns were shortened after final position. The perineal incision was closed in layers. The transurethral catheter was left in situ for 12-24 hours. After catheter removal and successful trial of voiding (urinate volume and post void residual were measured) patients were discharged and advised to refrain strenuous activity for four weeks.
Measurements postoperatively included 24h frequency volume micturition list, 24h pad test, 24h pad count and quality of life questionnaires at 4 weeks, 6 months, 1 year and yearly thereafter.
Results
93 patients were included, 69±6 years, pre-intervention 24h urinary loss 256 (79-355) grams. Directly after surgery, 65.9% of the patients was completely dry, 81.3% of the patients reported > 90% improvement of their urinary loss and 95.6% >50% improvement. Patients were observed up to 9 years. After five years of follow-up, 55.8% of all patients were completely dry, 70.5% reported an improvement >90% and 83.7% reported an improvement of >50%. Patients with preoperative urinary loss <250 grams reported significantly higher improvement of their urinary loss compared to patients with urinary loss ≥250 grams (p=0.03). Patients satisfaction was still increased after 5 years follow-up (71±20 vs.15±10, p<0.001) and patients quality of life remained high (84±22 vs. 86±16, p=0.1). Complications were mainly observed directly after surgery of which acute urinary retention and perineal pain complaints were most frequent reported (33.3% vs. 28.7%). In 2 patients sling removal was obtained due to wound infection respectively 2 and 3 months after implantation. During follow-up, sling explanation was performed in 2 other patients 3 and 7 years after surgery because of migration to the urethra.
Interpretation of results
This prospective study analyses the efficacy and complications of placement of an adjustable transobturator male sling with a single perineal route incision approach.We used objective and subjective outcome measurements and therefore we present here a true representation of results Most complications occur during the first year of follow up. This study indeed demonstrates the Argus-T sling single incision procedure is an effective and safe treatment of post radical prostatectomy stress incontinence.
To our opinion the key factor is that we perform a leak point pressure test during the procedure. Before and after placing the sling at the bulbar urethra a significant increase in Leak Point pressure must be achieved. So the mechanism is not only repositioning but also some compression without causing an significant obstructive flow.
A potential drawback is that this is a mono-center series performed by one urologist. Although it is general accepted that volume and experience are important for quality control of surgery, these results may be a reflection of the surgical skills of the operator. On the other hand, these results are in that case a strong argument for centralization of male sling surgery for PPI.