Study design, materials and methods
From April 2015 to September 2020 78 patients were evaluated in Our Department (median age 71,4 ± 7,2 years) with SUI after RP. 38 patients (48,7%) underwent adjuvant radiotherapy (RT). Inclusion criteria were: a good performance status (Sf-36 questionnaire), ICIQ-SF score (from severe to very severe), PAD test (according ICS) leak up to 40 g, presence of minimal external sphincter activity, urodynamic diagnosis of SUI.
Placement of AMS was carried out using the transperineal approach which consists to reach the corpus spongiosum avoiding the incision of the bulbospongiosus muscle (muscle-sparing approach). 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. Polypropylene mesh [3] was passed out the obturator foramen with two helical needles and fixed to the corpus spongiosum with 6 3-0 absorbable sutures. A cystoscopy was performed during tensioning to verify the absence of urethral injuries and to confirm proper coaptation of the sphincter. Catheter was usually removed after 48 hours. Postoperative assesment included VAS score evaluation and postvoidal residual volume (PRV). Subsequent follow-up (PAD test, ICIQ-SF, PRV) were performed at 1, 3, 12, 24, 36 and 48 months after surgery. Continence was defined as no pad usage or one pad for dryness sensation with an improvement of PAD test≥80%. Median follow-up was 32,4 ± 5,6 months (range 5-60 months). Results were evaluated through 4 major variables: patients' age (<80 Vs >80 years), body mass index (BMI), severity of incontinence (<40 Vs > 40 grams on PAD-test) and multimodal approach to prostate cancer.Chi-square test was used for statistical analysis.
Results
Immediate continence after catheter removal was reached in 76/78 (97,4%) patients. 2 patients (2,6%) had residual SUI, both underwent previous radiotherapy (RT). After vescical catheter removal, 9 patients (11,8%) showed acute urynary retention: of those, 8/9 (88.9%) previously undergone RT. These patients were treated through catheter placement for 7 days; then weekly evaluated for PRV. Overall, one patient recovered spontaneous urination at 3rd month postoperative and one on the 4th. All patients developed mild to moderate perineal and/or scrotal hematoma, spontaneously solved. None of patiets developed de novo urgency, neither short nor long term urethral erosion. After surgery mean VAS score was 5, 2 on day 2 posteperative and 0 within a week. Overall, 76/78 patients had complete continence at 1, 3 and 12-month follow-up. At 24 months, 74 patients were evaluated discovering 3 de-novo incontinences; on the other hand, none of the 72 patients evaluated at 36 and 48 months developed urinary leakage. All patients with new onset of incontience had previous RT.
BMI≥28 and previous radiotherapy were found being statistically significant on continence recovery and maintenance (p<0.001) compared to BMI<28 and non-irradiated patients rispectively; furthermore postoperative urinary retention was statistically (p< 0.001) more frequent in irradiated patients. Surprisingly, both age and preoperative severity of urinary incontinence were not a determining factor on medium- and long-term outcomes
Interpretation of results
AdVanceXP transobturator sling is best suited for treatment of mild to moderate SUI in male patients after radical prostatectomy. Overall, our data indicate an excellent recovery of urinary continence in medium-long period (≤24 months), and a subsequent slight decline in a cohort of patients undergone surgery plus radiotherapy. Moreover RT seems to be an indipendent risk factor of acute urinary retention due to radiation-induced detrusor hypocontractility. In our series, the subgroup of older patients showed similar results to <80 years old group in terms of urinary continence recovery and side effects such as urinary retention; therefore AMS is a safe procedure and can be performed even in motivated elderly patients.