Hypothesis / aims of study
The AdVance™ Male Sling System (AMS) is a transobturator male slings option proposed to manage stress urinary incontinence (SUI) after radical prostatectomy (RP) [1-2]. Our aim was to evaluate two different surgical approach to positioning the AMS in patients with SUI after RP, in terms of complications and short term results.
Study design, materials and methods
From April 2015 to October 2018 62 patients with a median (SD) age of 64 has been evaluated in our department with the diagnosis of SUI after RP. Inclusion criteria were: ICIQ-SF score (from severe to very severe), PAD test leak up to 40 g, presence of minimal external sphincter activity, urodynamic diagnosis of SUI. Placement of AMS was carried out using the classical transperineal approach which consists to reach the corpus spongiosum opening the bulbospongiosus muscle (AMS-NMS) or a muscle-sparing approach (without incision of the bulbospongiosus muscle) (AMS-MS). A midline perineal incision was made through the skin and carried out deeper through underlying fascia. The corpus spongiosum was mobilized and the central tendon was identified and gradually engraved. With the help of two helical needles a polypropylene mesh  was passed out the obturator foramen and fixed to the muscle in 6 points using 3-0 absorbable sutures. In both cases a cystoscopy was performed during tensioning to ensure no urethral injury and to confirm proper coaptation of the sphincter. 36 out of 62 were enrolled to perform the surgery with AMS and were prospectively randomized to AMS-MS (18) and AMS-NMS (18). Six patients (3 for each group) were previously treated with radiotherapy (RT). Cure was defined as no pad usage or one pad for security reasons with an improvement of PAD test ≥ 80%. The main complications evaluated were: perineal haematoma, local pain (VAS score) and urinary retention. The median follow-up was 6 months. Chi-square test was used for statistical analysis.
The rate of immediate continence after catheter removal was 78% (14/18) for AMS-MS and 56% (10/18) for the AMS-NMS group, 89% (16/18) and 72% (13/18) at 3 months, 94% (17/18) for both group after 6 months (p value <0.05). All patients in the AMS-MS group refer no relevant pain or haematoma after the surgery. Four patients in AMS-NMS group (4/18, 22%) shown moderate haematoma and refer low grade of pain (VAS score: 3) which required bland oral analgesics for the first week after surgery. There were 3 episodes of urinary retention (all in AMS-NMS group and all previously treated with RT, 3/6, 50%) after catheter removal, solved after one week of catheter rest.
Interpretation of results
AdVance transobturator sling is best suited for treatment of mild to moderate SUI in male patients, and can be used in cases of post radical prostatectomy incontinence. In this study we found a significant difference in the two groups in term of continence achievement: patients in AMS-MS group reach the continence faster than AMS-NMS. This could be explained with the integrity of the pelvic floor muscles in the first group which contributes to continence restore in short times. An interesting data was found about immediate complications: the AMS-NMS approach reported low to moderate complications compared to the AMS-MS group. This probably happen because a minor traumatism of the muscle reduces bleeding and consequently also pain. Another important data was the urinary retention episodes involved all patients in AMS-NMS group previously subjected to RT, which could be always justified by maintained integrity of the muscles.