Long-term outcomes of I-Stop TOMS™ male sling implantation for post-prostatectomy incontinence management

25 décembre 2017

Auteurs : B. Malval, J.-D. Rebibo, M. Baron, F.-X. Nouhaud, C. Pfister, J.-N. Cornu, P. Grise
Référence : Prog Urol, 2017, 17, 27, 1084-1090




 




Introduction


Prostate cancer is a highly prevalent disease in the western world [1] and radical prostatectomy is considered as a treatment of choice for localized disease [2]. Persistent stress urinary incontinence after radical prostatectomy (so-called post-prostatectomy incontinence [PPI] [3]) can significantly impact quality of life and requires specific surgical management in around 4% of cases [4].


Aside artificial urinary sphincter (AUS) implantation, minimally invasive options have been proposed for PPI management in the last 10years, including peri-urethral balloons and a variety of new generation male slings [5]. Male slings have become rapidly popular and fixed transobturator male sling are now recognized as a valuable alternative for mild to moderate PPI management in the most recent guidelines [6]. The I-Stop TOMSâ„¢ (CL Medical, France) is a fixed transobturator polypropylene tape, placed by perineal route, which provides a large support to the urethra [7]. Multiple studies have established the safety and short-term efficacy of this surgical approach [8, 9, 10], but long-term studies are lacking.


Our goal was to report the efficacy and safety outcome after I-Stop TOMSâ„¢ implantation for mild to moderate PPI management after long-term follow-up.


Patients and methods


Study design


A retrospective study was conducted in three university hospitals. All consecutive patients implanted with an I-Stop TOMSâ„¢ sling for PPI between June 2007 and May 2012 were included. Every patient had a preoperative workup including clinical examination, 24-hour pad test to assess incontinence severity, urodynamics study (UDS) to rule out severe detrusor dysfunction (overactivity or impaired contractility), and urethrocystoscopy to rule out urethral stenosis or anastomosis stricture. All three centers had applied the same criteria for I-Stop TOMSâ„¢ implantation during the study period: mild to moderate PPI (24hour Pad test<400g and pad use<6pads/day), persisting after at least at least 12months after radical prostatectomy, with undetectable PSA. Patients with previous pelvic radiation therapy, neurological disease, urethral stenosis, severe detrusor dysfunction at UDS, chronic retention were excluded from the analysis. In lieu of a formal ethics committee, the principles of the Helsinki Declaration were followed.


Intervention


All patients were implanted with an I-Stop TOMSâ„¢ sling under general anaesthesia as previously described, by three surgeons having appropriate expertise of male incontinence therapy [7]. A urine culture was required before intervention, and patient received antibiotics in case of positive results. No systematic administration of antibiotics was scheduled postoperatively. Urinary catheter was removed after 48h and patients were discharged after two voids and acceptable post-void residual volume (<100mL). Patients were scheduled for postoperative visits at 1, 3, 6months and yearly thereafter.


Data collection


Patient characteristics, perioperative data and immediate follow-up were recorded in a common database gathering all cases from the three centers. At baseline, the following parameters were prospectively recorded: age, uroflowmetry, pad usage, validated quality of life questionnaires (International Consultation of Incontinence Questionnaire [ICIQ] [11], SF-36 quality of life questionnaire), and 24h pad test. Short-term postoperative data (date of intervention, immediate complications) were collected in each centers on a yearly basis. In 2015, all charts and follow-up data were reviewed and a telephone interview by a non-surgeon third person was proposed to all patients to evaluate treatment efficacy and complications. Data collected at this stage were pad usage, ICIQ and SF-36 validated questionnaires, a satisfaction questionnaire and a perineal pain scale.


Efficacy of the treatment was the main outcome criterion. Success was defined by no pad usage. Patient were stated as improved if pad usage was reduced by 50% or more, and failure was defined by less than 50% of improvement on pad usage, worsening of the symptoms (including increased pad use), or salvage surgery by a second line surgical procedure (AUS, peri-urethral balloons, or re-do sling).


Statistical analysis


Descriptive analysis was conducted for every patient characteristic and outcome parameter. For pad usage analysis, used as the main outcome, a year-by-year description of status (cured, improve or failed) was provided. Any patient with further anti-incontinence surgery or failure was considered as failed for the rest of subsequent follow-up, regardless he answered or not to the phone interview. Patients lost to follow-up who were not re-operated or previously classified as failure were put out from the main analysis, and included as failures in a secondary analysis to avoid attrition bias. Pad use evolution with time was studied by Student test for the first 4 years and with a Wilcoxon test for the fifth year because of a smaller group. The assessment of predictive factors was done through univariate analysis (Student test). Data were analyzed with SAS 9.2 (Cary, NC, USA).


Results


Patient characteristics


One hundred consecutive patients were included with a median follow-up of 58months [19-78]. Preoperative characteristics are displayed in Table 1. All patients had mild to moderate incontinence. At one year of follow-up, 95 patients were analyzed (5 operated patients were excluded due to radiotherapy, secondary onset of a neurological disease). At 2years of follow-up, 22 patients were lost to follow-up and 17 patients underwent an additional surgical procedure due to short-term failure. As detailed in Figure 1, 26 patients were lost to follow-up and thus 41, 32 and 21 patients had complete evaluation after 3, 4 and 5years.


Figure 1
Figure 1. 

Patient flowchart.




Efficacy


Pad usage was significantly decreased at each time point compared to baseline (P <0.001) (Figure 2). In the short-term, 38% of patients were dry and 77% of patients used 0 or 1 pad. After a medium- to long-term follow-up, the results dropped progressively with a rate of patient dry of about 40% initially to 23% and 15% after four and five years, respectively. Three patients had short-term worsening of their symptoms. The failure rate was 34% at one year, and 18 required further surgical treatment of their incontinence (12 had an AUS placement, 5 patients were treated by proACT â„¢ balloons and one by a second I-Stop TOMSâ„¢ sling). None of these patients underwent sling removal during secondary surgery. No preoperative factor was found to be significantly associated with failure.


Figure 2
Figure 2. 

Efficacy data over time. The bars show the percentages of patients cured, improved of failed during follow-up (years of follow-up are plotted on the x -axis). For complete accuracy, the number of patients not considered for analysis is detailed under the display. The complete sample at 1year was 95 patients.




ICIQ and SF-36 questionnaires (Table 2) have shown a similar evolution with good short-term outcomes and worsening secondarily after 3years. Symptoms were however improved at each time point compared to baseline. The satisfaction rate was excellent with very satisfied patients regarding the surgery. It was worse for the patients who were not improved but still good regarding the surgery itself.


Complications


After short-term follow-up, one patient complained of occasional perineal pain symptoms, persisting after two years (2/10 on a pain scale, and no need for further treatment). No erosion, urinary retention, infection or chronic perineal pain was recorded during follow-up.


Discussion


Male slings are now considered as a first line option for PPI management, especially for mild to moderate symptoms [6]. A number of slings have been marketed during the past 10years, with various designs, materials and surgical approaches, making "male slings" a heterogeneous group [5, 12, 13]. Furthermore, the use of each sling is supported by the same amount of evidence, according to recent literature reviews [5, 12, 13]. Fixed male slings placed by transobturator route, such as Advanceâ„¢ (AMS, Minnetonka, Minnesota, USA) and I-Stop TOMSâ„¢ have shown promising short-term efficacy results with an excellent safety profile [3, 6, 7, 8, 9, 10, 14, 15, 16], but long-term results are lacking. Adjustable male slings have shown also good efficacy in the short term, but a high rate of complications [6], and 4-arm devices have been rather disappointing according to recent reports [17]. Last but not least, no well-designed comparative study has been published to date.


Numerous cases series about fixed male slings have been published focusing on patient selection to try to depict the best candidates for male sling implantation. Predictive factors of failure proposed in the literature include severe incontinence, previous surgery for urethral stricture, history of radiation therapy, and low residual sphincter function [18, 19, 20, 21, 22, 23]. Exclusion of these patients has thus led to consider rather favorable profiles for male sling implantation. This can explained the good short-term results obtained in our cohort, with 40% patients dry and 77% of them wearing 0 or one pad. These data are close to those reported in the vast majority of the literature about Advanceâ„¢ [3, 14, 15, 18, 19, 20, 21, 22, 23, 24] and I-Stopâ„¢ [8, 9, 10].


The main asset of our report is long-term data that have never been reported before. While showing a very good safety profile in the long term, the efficacy of the sling seems to significantly decrease with time. Symptoms recurrence has been shown to occur as early as after two years, then slightly but continuously with time. In order to compensate for the loss of follow-up, considering all patients censored or dropped out as failures would lead to a dry rate of less than 10% after five years. Conversely, if every lost to follow-up was treated by last observation carried forward method, the dry rate would drop anyway to 32% at 4years and 26% at 5years, and improvement rate would be 20% and 18%, respectively. Despite no previous study had gone beyond further 3years of follow-up for an entire group of patients, previous reports have postulated a loss of efficacy over time and the need for long-term studies [15, 24]. Recurrence of incontinence after sling placement for PPI management is thus a newly established issue, with three major implications discussed hereunder: pathophysiology of symptoms recurrence, management of failures, and patient information.


Possible explanations for symptoms recurrence are multiple. First, patient aging in the long term can unmask further decrease of sphincter function, as slings properly provide urethral support and mild compression, but require a good sphincter residual function contrarily to AUS. In a few cases, additional physiotherapy has been proposed for long-term recurrence of symptoms, and has led to a mild improvement. As Hilton stated about long-term follow-up studies in functional urology [25], results are submitted to the bias of age and other deficiencies. This concept includes overactive bladder and possibly urge incontinence, which could impact the results. Since our evaluation was mainly driven by pad use and satisfaction questionnaires, we may have disregarded alternative causes of recurrence or failures such as detrusor overactivity or detrusor dysfunction. The second reason that could explain incontinence recurrence is the loosening of the sling attachment over time or a migration of the sling posteriorly and down from the urethra. Unfortunately, no imaging data were available for our patients with secondary failure.


Given the rate of male sling implanted, if our results are confirmed, many patients will have to be offered a new additional treatment for PPI recurrence after male sling. These challenging cases are to be treated in a tertiary reference center for male incontinence, as clinical decision-making might be difficult. Technically, all options have been reported in the literature about second line therapy after a fixed male sling and include a second sling, AUS implantation, or peri-urethral balloons. The choice between these options includes leakage intensity, patient preference, and clinical background. Whilst all options have been tested in our groups, no conclusions can be made due to the low numbers. The biggest series to date have reported 30% success rate with a re-do sling [26], and 50% improvement with secondary implantation of ACT balloons [27]. The success rates after AUS implantation are close to those obtained in comparable virgin cases [28].


Lastly, if our findings are confirmed by other groups working on male slings, patient information may change before initial implantation of a fixed male sling for PPI. Indeed, the patients should be warned that the results are not stable over time especially in the long term, and that an additional surgery may be required a few years later. However, the safety profile of the sling in our study remained excellent.


Although our study provided key information in the field, it has some limitations that have to be considered, and should lead to careful interpretation. Beyond its retrospective design and the limited number of patient included, a limit of our study is the pad use as a main criterion, as pad use might not perfectly reflect incontinence symptoms and severity [29, 30]. Although pad use reflects the patient's condition, the 24-hour pad test was not done for all the patients during the follow-up and reliable results could not be shown. However, most of the literature is based on pad use, as a main criterion, which allows comparison with time in the same patient, is easy to measure and remains an acceptable marker of the patient's discomfort.


Another significant limitation of the study is the loss of patients at each time point. This could bias the results when leading comparative testing during follow-up. However, we considered that a fair report of patient numbers, as an annual report of the device function is particularly interesting and more useful than a median follow-up to appreciate the risk of deterioration over time.


Furthermore, the first cases included in this study are part of the learning curve of the surgeons who participated. As to our knowledge no reliable data regarding male sling learning curve are available, the impact on our results is difficult to quantify. Finally, as previously discussed, our patient selection was limited to good candidates, which makes the results relevant only for this group of patients.


Conclusion


I-Stop TOMSâ„¢ implantation for mild to moderate PPI management is a safe procedure with good short-term efficacy in carefully selected patients. However, long-term results have shown a decrease in efficacy during follow-up, in favour of recurrence of incontinence in the long term. If confirmed by further studies, these results may have several implications for patient information and clinical decision-making.


Disclosure of interest


JNC is consultant/advisor/investigator for Astellas, Boston Scientific, Allergan, Coloplast, SAP, Medtronic, Recordati, Pierre Fabre Medicaments, GSK.


PG is consultant for Astellas.


BM, JDR, MB, FXN and CP declare that they have no competing interest.



Acknowledgements


None.




Table 1 - Preoperative patient characteristics.
Age (years)a  68 [54-82] 
Uroflowmetry (Qmax , mL/s)a  20,95 [5-50] 
Pad use/daya  2 [1-6] 
24hrs Pad test (g)  185 [50-400] 
SF-36 scoreb  286±150 [50-500] 
ICIQ scoreb  13±3 [8-19] 



Légende :
ICIQ: International Consultation of Incontinence Questionnaire; Qmax : maximum flow rate at uroflowmetry.

[a] 
Median values and extremes boundaries in brackets.
[b] 
Mean means±SD [range].


Table 2 - Evolution of the SF-36 and ICIQ questionnaire over time (presented in mean±SD [range]).
  Preoperative  1 year  2 years  3 years  4 years  5 years 
SF-36 questionnaire  286±150 [50-500]  302±139 [50-500]  294±133 [50-500]  281±130 [50-500]  256±149 [50-500]  194±136 [50-500] 
ICI-Q questionnaire  13±3 [8-19]  7±5 [0-20]  6±5 [0-19]  8±5 [0-21]  8±5 [0-19]  9±6 [0--9] 
Number of patients  100  95  51  43  32  21 




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© 2017 
Publié par Elsevier Masson SAS.