Hypothesis / aims of study
Urinary incontinence is a hostile complication following radical prostatectomy in patients with prostate cancer. The AUS achieves higher continence rates than male slings; however, its revision rates are not insignificant.
The aim of this study was to investigate whether the Advance XP sling could be an effective treatment option to improve quality of life in patients with severe PPI, including those who had undergone prior radiotherapy (RT), at 12 months follow up.
Additionally, we assessed clinical and urodynamic features as predictors of success or failure among all patients and between groups.
Study design, materials and methods
Thi is a prospective study assessing the satisfaction, social continence and urodynamic predictors of failure for patients who had undergone to male sling to treat PPI.
All patients underwent a standard procedure involving the implantation of the male sling (Boston Scientific AdVance™ XP Male Sling System).
Baseline symptoms such as urgency and nocturia were also recorded. All patients underwent urodynamic studies prior to sling implantation, following the best practices recommended by the International Continence Society (12).
The parameters assessed included cystometric capacity (ml), presence and amplitude of detrusor overactivity (cmH2O), bladder sensivity and compliance (ml/cmH2O), abdominal leak point pressure – ALPP (cmH2O) and leakage volume. Pressure-flow studies were also perfomed in all patients.
Postoperatively, patients were evaluated regarding their satisfaction with the procedure [Patient Global Impression of Improvement (PGI-I) - ranging from 0% – not at all satisfied – to 100% - totally satisfied], improvement in quality of life (QoL), as well as changes in PPD usage, severity of nocturia, and urgency.
The correlation between patient satisfaction after the procedure and all clinical and urodynamic parameters were analyzed. Patients with prior Radiotherapy (RT) were assessed separately after que initial analysis, to determine whether the outcomes were inferior compared to those patients without RT, according to previous evidence
Results
Fifty-eight patients with severe post prostatectomy urinary incontinence underwent Advance XP male sling.
The two groups (Radiotherapy vs without Radiotherapy) were similar, although significant differences were observed between them regarding ALPP and cystometric capacity (CC). The group that had undergone RT presented lower ALPP and lower CC.
Overall satisfaction at 12 months follow-up in patients with severe urinary incontinence was high (mean 86,717.1 %). There was no difference between groups regarding satisfaction [RT group 82.3% vs Non-RT group 90%, [p=0.146 (-4.06,19.4), Mann Whitney test].
It was not found any difference after surgery in PPD used, post operative SCT or urgency between patients with or without RT, although patients with RT had lower ALPP preoperatively (p<0.05).
A bladder capacity (CC < 300 ml) emerged as the main feature which predicts poorer outcomes, regarding higher rates of detrusor overactivity (p=0.02), satisfaction (p=0.02), early leakage volume (p=0.02) and increased nocturia (p=0.02), presenting statistical differences
Interpretation of results
We believe our results highlight and urge new further large-scale and prospective studies to assess the efficacy of the Advance XP in patients with severe urinary incontinence. This is particularly important especially due to the higher costs of the artificial urinary sphincter in developing countries, where AUS is not easily available. We attribute our favorable results to surgical technique, especially due to the urethral mobilization through the release of the central tendon of the perineum, a critical and essential step during the surgery to achieve continence postoperatively.