Hypothesis / aims of study
Post radical prostatectomy urinary incontinence (PPI) is one of the most feared consequences of prostate cancer surgical treatment and its occurrence has a major negative impact on quality of life(1). Around 6% of the patients undergoing radical prostatectomy will have surgical treatment for PPI(2). Male slings (MS) are attractive alternatives to the artificial urinary sphincter (AUS), their indications have increased due to lower cost, practicality, reproducibility and shorter learning curve. Recent results and adverse event profiles are encouraging.
Our objective is to identify predictor factors for MS readjustment and success.
Study design, materials and methods
From 2009 to 2018, 89 patients underwent correction of PPI using adjustable transobturator MS (Argus-T, Promedon™, Argentina). Open abdominal radical prostatectomy was the procedure in all the patients. Prior to implantation and during follow up, patients were accessed through clinical evaluation, 24h pad test, IIEF-5, ICIQ-SF, Patient Global Impression of Improvement (PGI-I) and Visual Analogue Scale (VAS) for treatment satisfaction. Urodynamics and terminology followed ICS standardization. All the patients were operated by the same surgeon. We applied some surgical details that we believe can prevent infection and erosion, such as distancing the crural incisions from genitofemoral fold, and the medial and anterior path of the subcutaneous hidden excess of silicone arms, preventing their passage under this skin fold.
The sling tensioning was based on urethral retrograde perfusion pressure, reaching between 35 and 40 cmH2O. Readjustments were done only after one month. Only tightening was required, and the tension was readjusted to 35 to 40cmH2O. Clinical and urodynamic variables were correlated to outcomes and to the need for readjustments, adjusted to the uni and multivariate logistic regression model.
The success analysis was performed after readjustments, considering that all patients who needed readjustment failed in the first surgery. And those who didn't need it, were successful in the first surgery.
Success was defined by cure or improvement. The definition of objective cure was dry patient; of improvement, decrease >50% number of pads; and of fail, decrease <50% numbers of pads or unchanged.
The definition of subjective cure was VAS >=8 and PGI-I “very much better or much better”; of improvement, VAS 6-7 and PGI-I “little better”; and of fail, VAS <=5 or unchanged.
Results
Patients characteristics and perioperative variables are reported in Table 1.
Objective success was achieved in 80.5% of the patients (72), 65.9% cure and 14.6% improvement; 19.5% fail (17). Subjective success in 85.4% of the patients (76), 74.4% cure and 11% improvement; 14.6% fail (13). Median ICIQ-SF decreased from 18 to 6 (p<0.001).
A first readjustment was done in 25.8% of the patients (23) while a second in 6,7% (6). Of these patients, 56.5% (13) achieved success after the first readjustment. If considered the second readjustment, 65.2% (15) reached success definition.
Radiotherapy and urethral stenosis were associated with the need of readjustments in univariate and multivariate analysis models (p=0.002 for each variable). There were no more variables associated to the need of readjustments. There were no variables associated to success.
Of the irradiated patients (20), 75% achieved objective success and 80% subjective success. However, 66.7% of them have done readjustments.
There were 18 patients with previous urethral stenosis, 61.1% (11) needed readjustments and achieved similar success rates after it.
In our casuistic; there were 5 cases of sling removal, 4 due infections and one due to permanent retention and pain. There were no cases of urethral or bladder erosion. Three of the five patients were dry, and had their sling removed more than 2 years after implantation, these three patients remained dry after removal.
Interpretation of results
Sling readjustment benefits 25% patients who were treated for PPI and two thirds of those with previous radiotherapy or urethral stenosis.
The success rates of the male sling should be analyzed according to each device specifically, and not generically as in the female sling. The success rates in this study are similar to those previously published for this device, however, the complications and adverse events are lower, especially regarding infection rates and sling removal.
Further studies are still needed to indicate predictive factors for success as well as for the success of the readjustment.