Fixed or Adjustable Sling in the Treatment of Male Stress Urinary Incontinence

Results From a Large Cohort Study

Tanja Hüsch; Alexander Kretschmer; Alice Obaje; Ruth Kirschner-Hermanns; Ralf Anding; Tobias Pottek; Achim Rose; Roberto Olianas; Alexander Friedl; Roland Homberg; Jesco Pfitzenmaier; Rudi Abdunnur; Fabian Queissert; Carsten M. Naumann; Josef Schweiger; Carola Wotzka; Joanne Nyarangi-Dix; Torben Hofmann; Kurt Ulm; Wilhelm Hübner; Ricarda M. Bauer; Axel Haferkamp

Disclosures

Transl Androl Urol. 2020;9(3):1099-1107. 

In This Article

Discussion

The present study investigated the differences in selection criteria, complication rates and outcome in comparison between fixed and adjustable MS for the treatment of male SUI in clinical daily practice. Although the indications for a fixed or an adjustable MS may be different in clinical practice, to our knowledge, only one randomised study with a limited patient population exist.[7] There is still no evidence that one sling is superior to another and the additional benefit of adjustability remains unclear.[5]

In preoperative selection criteria, we could demonstrate that patients with risk factors such as diabetes mellitus, history of pelvic irradiation, and prior urethral stricture disease are more likely to receive an adjustable male sling rather than a fixed sling. Furthermore, adjustable slings were more frequently offered secondary to prior failed surgical treatment of male SUI and even offered to patients with failed artificial urinary sphincter. This raises the question if whether or not this may imply a negative impact on the outcome of adjustable slings. Recent studies demonstrated low complication rates for male slings in general including adjustable male slings and the only independent risk factor for explantation was a history of pelvic irradiation.[2] This is consistent with recent studies of fixed[6] or adjustable slings,[14] reporting successful utilization even in patients with risk factors or high degree of incontinence. These results are consistent with the current trial which demonstrated comparable complications rates and functional outcome.

A problem with comparability between fixed and adjustable slings is the definition of the degree of urinary incontinence. Although, most studies suggest adjustable slings for moderate to severe and fixed slings for mild to moderate incontinence, the definitions vary widely. Depending on the study, the definition is either clinical according to the Stamey-classification, pad use per day[14] or by urine loss in the 24 h-pad test.[4] This implies a wide variety of incontinence degrees with different outcomes depending on the used definition. In the present study, the clinical definition by Stamey and the 24 h pad test were included. The discrepancy according Stamey classification was marginal (1.9 vs. 2.3). The 24 h pad test did not demonstrate significant preoperative differences but there was a tendency for higher urine loss and larger range of urinary incontinence degree in adjustable slings. This could be interpreted in favor for adjustable slings since outcome was comparable although more risk factors were present.

The mean operation time for the adjustable MS was significantly longer, however, the mean difference was merely five minutes. The importance of this statistical difference may therefore be negligible in routine practice. Interestingly, intraoperative complications occurred in particular with the Argus classic due to bladder perforation during implantation. This might be referred to the learning curve of the surgeon or due to a particular higher risk in the retropubic route. This complication has been described before[15,16] and maybe explained by perivesical scarring or even change of bladder position after radical prostatectomy. Nevertheless, the perforations were all identified and revised intraoperatively and besides prolonged postoperative catheterisation, no further treatment was necessary.

In postoperative complications, pain and infection rates were significantly higher in patients with adjustable male slings. The infections were localized at the adjustment site or at the sling arm itself. Nevertheless, infections are generally rare and the total amount of infections was 2.3% which is in line with other studies.[2] Furthermore, the results may be underpowered due to the low patient number affected by infection. Regarding postoperative pain, Argus-T was particularly more frequently associated with pain which might be referred to the transobturator route and the rigid material. Nevertheless, in long term follow up this difference was not present anymore.

Pain at follow-up was significantly higher for adjustable MS. However, taking into account all anatomical sites (perineum, inguinal groin, genitals, symphysis) the mean difference amongst fixed and adjustable MS was reported between 0.8 and 0.3. This raises the question whether or not this difference arises a clinical impact for decision making in the choice for the sling type. However, in two patients the Argus had to be even removed due to persistent pain and unchanged SUI, hereby presenting a high impact for individual cases.

In the prospective analysis of the present study, no significant differences could be identified regarding quality of life, 24 h pad test, pad use or satisfaction rate between fixed and adjustable slings. Considering, that patients who received an adjustable sling presented significantly more often risk factors for failure, this may imply an advantage for adjustability. Furthermore, adjustability may be an advantage in the long term in case of distension of the sling arms. This is consistent with a different trial evaluating the satisfaction and incontinence rates in comparison of Argus und AdVance in a smaller cohort with 44 patients.[8] A randomized prospective trial evaluating the outcome of AdVance vs. Argus identified significant differences in the 24 h-pad test although satisfaction rates and quality of life were comparable.[7] Nevertheless, only 22 patients were included and therefore the results most probably are underpowered.

We acknowledge current limitations in our study with a partially retrospective design and a mid-term follow up. Even though the multi-institutional character of the present study reflects routine practice, it involves inhomogeneous patient cohorts and operation techniques. Furthermore, selection criteria for fixed and adjustable sling was not standardized. Nevertheless, all involved institutions are experienced in the treatment of urinary male incontinence and therefore represent the current standard of care. Besides, in our opinion, the strengths of the current study are the multicenter character which reflects the actual results of clinical daily practice in Germany and Austria. The results are therefore of importance for the interpretation in routine practice.

In conclusion, patients with risk factors and a higher degree of urinary incontinence are more likely to be offered an adjustable MS. In comparison between adjustable and fixed MS, no significant differences in functional outcome and quality of life could be identified. Considering the wider indication for adjustable slings, adjustability may imply an advantage over fixed sling. However, infection as well as pain rate were significantly higher in adjustable slings implying a significant impact for the patient. Hence, adjustable male slings may be in favor in patients with risk factors and higher degree of urinary incontinence at the cost for higher risk for pain and infection. However, there is still uncertainty regarding the significance of adjustable MS in patients with mild urinary incontinence.

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