Sequential treatment with ProACT™ device implantation after male sling failure for male urinary incontinence

25 décembre 2017

Auteurs : M.G. Baron, C. Delcourt, F.-X. Nouhaud, A. Gillibert, C. Pfister, P. Grise, J.-N. Cornu
Référence : Prog Urol, 2017, 17, 27, 1098-1103



Stress urinary incontinence (SUI) is one of the major complications after radical prostatectomy. Its prevalence is hard to define precisely but seems to range from 4% to 31% at one year post-prostatectomy owing to no pad definition [1]. Although artificial urinary sphincter (AUS) is the gold standard for moderate to severe male SUI, there is no strict recommendation for treating mild to moderate SUI. Male fixed or adjustable sling might be proposed to the patients along with bulking agent [2]. I-STOP TOMS has shown good improvement for mild to moderate incontinence with 87% of patients reported improvement [3]. However, there is no strong recommendation for second line therapy after male sling failure, which can occur in 13% of cases [3]. Periurethral bulking offers temporary relief of continence symptoms and regenerative therapies need further investigation and long-term studies in men [4]. ProACTâ„¢ device is an efficient technique, which showed good results in first line therapy after radical prostatectomy [5]. Only one study has reported efficacy of ProACTâ„¢ device after male sling failure [6]. Our aim was to report use of ProACTâ„¢ device after I-STOP TOMS failure for post-radical prostatectomy urinary incontinence (PRPUI).


Study population

It is a retrospective study of all patients, with post-prostatectomy or post-ablatherm urinary incontinence, who choose to be implanted with a ProACTâ„¢ device (Uromedica, Inc., MN, USA) after I-STOP TOMS failure in a tertiary reference center between May 2009 and February 2016. I-STOP TOMS failure was defined as persistence of leak more than 8g per 24h or more than one pad per day and desire of the patients to have another treatment. All patients gave written informed consent to participate in the study. Given the retrospective nature of the study and the absence of experimental arm, the work was conducted in accordance with the provisions of the Declaration of Helsinki.

Intervention technique

The device implantation was performed under general anesthesia in outpatient procedure with slight differences from previously described technique [6]. Patients were operated in dorsal lithotomy position and the bladder was filled with 200mL of contrast solution (Omnipaque 350). A rigid cystoscopy was done to check bladder neck position on concomitant fluoroscopy. Two cutaneous incisions were made bilaterally, medially to the ischiatic rami. The U-channeled sheath was introduced through the incision and directed toward the bladder neck under fluoroscopic and fibroscopic control. Balloon was placed just below the bladder neck, laterally close to the urethral wall. The trocar was then removed and the balloon was inserted in the sheath to the area below the bladder neck and immediately laterally to the urethra. This step was controlled by fluoroscopy as a radiopaque marker was at the top of the balloon. Once the balloon placed in good position, the U-shape sheath was withdrawn and the balloon refilled with 0.5mL of contrast (omnipaque 350, 73%) and sterile water (27%). The same procedure was done in the other side, symmetrically. Finally, a blunt dissection was performed toward the scrotum to place the balloon ports under the skin. No urinary catheter was put at the end of the procedure. The presence of male sling did not affect surgical technique. All patients were discharged at day 1 and were seen at 1 month to inflate balloon with 1mL of contrast solution. If needed, complementary filling of the balloon was done 1mL by 1mL, one time per months until full continence was achieved or until the limit of 8mL. This filling was made through a percutaneous injection in each scrotal port.

Preoperative evaluation

All patients were clinically evaluated prior to surgery with physical examination, pad count and a 24h pad-test.

Postoperative evaluation

Patients were seen at every inflation with a pad-test and every 6 months afterward. Patient Global Impression of Improvement (PGI-I) and a five-point Likert scale satisfaction (0 unsatisfied, 1 nor unsatisfied, nor satisfied, 2 mild satisfaction, 3 satisfied, 4 very satisfied) evaluation were made by telephonic questionnaire when collecting the data. Objective success was defined as a pad-test less than 8g per day and subjective success, when patient needed less than one pad per day or use only one pad for security.

Statistical analysis

A student test for paired data with logarithmic transformation was conducted to compare pre and postoperative values.


Baseline characteristics

Fourteen patients were included in the study. Baseline characteristics are listed in Table 1. No patients had severe incontinence. One patient (7%) had two internal urethrotomy and one urethral stenosis excision by perineal surgery before TOMSâ„¢ implantation for stenosis of the uretro-vesical anastomosis and one patient (7%) had past history of radiotherapy after prostatectomy.

Postoperative evaluation

All patients were seen at one month to inject 1mL in each balloon. At the end of follow-up, mean volume of adjustment was 4mL [2-7.5]. Median follow-up was 34 months [4-89] with a median pad-test of 34g [4-300] evaluated at last follow-up.

Objective cure was 29% (n =4) and subjective cure was 57% (n =8) after ProACTâ„¢ device implantation. Objective cure was achieved within a mean time of 12 months [0.9-23.3] and a mean volume of adjustment of 3.1mL [2-4.5]. Median pad-test decreased from 175g [interquartile range (IQR): 180] to 95g after I-STOP TOMS implantation [IQR: 130] and 34g [IQR: 83] after ProACT device implantation (cf. Figure 1). ProACTâ„¢ device implantation significantly decreased median pad-test from I-STOP TOMS implantation by a factor 2.73 [1.19-6.29], P =0.022. The difference was also significant compare to post-prostatectomy median pad-test, P =0.0017.

Figure 1
Figure 1. 

Twenty-four-hour median pad-test evolution after each procedure.

Three patients (21% [CI 95: 5%-51%]) worsen their continence after ProACT device implantation. All those patients had an initial 24h pad-test above 250g. Results of Likert scale and PGI-I questionnaires are described in Figure 2, Figure 3. Of nine patients who answered, 8 (88%) were feeling a little better, much better or very much better at the end of follow-up and 7 (77%) were satisfied or very satisfied about the surgery. One patient (12%), not satisfied with the surgery, was waiting for AUS device implantation. Of the five patients who did not answer, two were objectively continent at lost to follow-up while one had had an AUS implanted afterward. The two remaining had a pad-test of 70g and 300g respectively at lost to follow-up.

Figure 2
Figure 2. 

Postoperative PGI-I questionnaire.

Figure 3
Figure 3. 

Postoperative satisfaction Likert scale.

Reoperation rate was 28% (n =4), Appendix A. Two patients had migration of the balloon caudally and one had his left balloon spontaneously deflated. Among them, one had past history of radiotherapy. All three had their balloon changed and refilled. The fourth patient had a postoperative pad-test at 260g and was implanted with an AUS device. He achieved continence with a median follow-up after implantation of 13 months. The patient who had previous radiotherapy failed to achieve continence and was proposed for AUS device implantation at last follow-up.


ProACTâ„¢ device can be proposed after male sling implantation with satisfaction rate as high as 77% and a 54% rate of subjective, after a median follow-up of 34 months. After male sling failure, ProACTâ„¢ device implantation might decrease 24h pad-test by a factor 2.73. We present the largest series to date of ProACTâ„¢ device implantation after failure of male sling I-STOP TOMS.

Another study has shown 66% of success with ProACTâ„¢ device after male sling implantation (2 Invance, 9 I-STOP TOMS, 9 Advance). This difference may be caused by definition of full continence, which is more restrictive in our study (pad-test<8g/24h versus one or no pad use) [6].

How ProACTâ„¢ can improve continence and how its association with I-STOP TOMS could enhance continence is not fully understood, even if an increase in urethral pressure seems a possible explanation. MRI imaging studies showed that importance of PPI (post-prostatectomy incontinence) was correlated with the periurethral fibrosis [7] and the membranous urethral length (which is the distance between bladder neck and the penile bulb). Other urodynamic studies after radical prostatectomy (RRP) demonstrated that urinary incontinence after RRP was associated with a decrease in maximum urethral closure pressure (MCUP) and functional profile length (FPL) and that low preoperative value of MCUP and FPL were associated with and increased risk of postoperative incontinence [8]. In a literature review, Dubbelman and Bosch [8] show a significant decrease of the functional urethral length after RRP from 5.0cm (range 4.3-6.1cm) at baseline to 2.6cm (range 1.6-3.1cm) postoperatively (range 2-10 months after RRP). In this article, they also found a median decrease of MCUP from 73cmH2 O (49-95cmH2 O) to 56cmH2 O (30-83cmH2 O) postoperatively. In another study, 6months after radical prostatectomy, they observed that patients who regained continence had a significantly higher median MUCP before and after operation as compared to incontinent patients [9]. Reuvers et al. in 2016 showed a significant elevation of MCUP and FPL in patients successfully treated with ProACTâ„¢ device [10]. Patients who were fully continent had a higher gain of MUCP compare to other patients from 58cmH2 O preoperatively (47-71) to 79cmH2 O (56-136). Mean FPL was 2.9cm (2.4-5.2) preoperatively and 4.3cm (3.2-5.5) postoperatively. However, the changes in FPL were not significantly different between successful and unsuccessful groups but this could be due to the insufficient amount of patients in unsuccessful group (n =4). This suggests that ProACTâ„¢ device could obtain continence by increasing static urethral pressure.

The I-STOP TOMS seems to act in a similar way. Rehder and Gozzi [11] showed in five patients that transobturator sling modified significantly MCUP from 13cmH2 O to 86cmH2 O postoperatively and that FPL increased from 3mm to 17mm.

There is no study that evaluates urethral pressure profile in patients implanted with both I-STOP TOMS and ProACTâ„¢ device. However, the devices are placed in a different position around the urethra. By increasing urethral pressure at two different locations, this association may lead to an increase in FPL that could lead to continence. Furthermore, the position of the device is not the same, the transobturator sling producing a sub-urethral compression while balloons are placed laterally to the urethra. Although this idea is attractive, it cannot fully explain continence in these patients because some successfully treated patients with ProACTâ„¢ device did not have significant modification at the dynamic urethral pressure profile [10].

Another explanation of success is the compression of the urethra toward the pubic bone as shown in cadaveric patients [11]. However, this was not shown after prostatectomy where fibrotic tissue may hamper this phenomenon.

Some authors [6] have suggested that the association of ProACTâ„¢ device after male sling could be an alternative for severe incontinence in patients not eligible to AUS with three out of four patients being fully continent at the end of follow-up in their study. In our study of fourteen patients with severe incontinence, three had their continence worsen after ProACTâ„¢ device implantation. Those patients had initial pad-test superior to 250g. Continence after prostatectomy is the result of a fragile equilibrium, which implies levator ani muscle, intrinsic sphincter and fibrotic connective tissue. We should be aware that continence surgery might alter one of these elements and hampers continence as shown for two patients in our study. Indications must be put precociously and patients warned of a potential worsening of continence and unpredictable outcomes.

Furthermore, reoperation (28%) rate of ProACTâ„¢ device implantation after male transobturator sling matches with those of the literature of ProACTâ„¢ first line therapy [12, 13]. There does not seem to be an increasing morbidity in this second line therapy nor than technical difficulties in the ProACTâ„¢ device implantation. Furthermore, ProACTâ„¢ device after I-STOP TOMS does not seem to hamper another continence surgery, such as SAU as shown in one patient. Other studies [14] have shown same results in patients treated by SAU in first line therapy or after male sling failure.

We are aware of the limitations of our study. It is a monocentric, retrospective cohort with no urodynamic data. Population is heterogeneous, which might have influenced the outcome and PGI-I is a non-specific questionnaire that might not reflect the improvement of the given treatment. Furthermore, we did not seek for urge urinary incontinence after ProACTâ„¢ device implantation which might be responsible of persistent leakage. However, this study shows that a combined therapy is possible and that failure of I-STOP TOMS could be managed with ProACTâ„¢ device implantation.

ProACTâ„¢ is a safe treatment that can be used as an alternative to AUS device implantation, in second line therapy after transobturator male sling for post-prostatectomy incontinence with high satisfaction rate for selected patients. Patients who had severe incontinence (especially pad-test>250g) must be informed before ProACTâ„¢ device implantation of a possible worsening on continence.

Author's contribution

All authors contribute to this article by drafting and revising the article critically for important intellectual content.

Pr Jean-Nicolas Cornu did final approval of the version to be published.

Disclosure of interest

The authors declare that they have no competing interest.

Appendix A. Supplementary data

(18 Ko)
 Table S1 
Table S1. 

Complications and reoperations after ProACTâ„¢ device implantation.

Table 1 - Baseline patients characteristics.
n   14 
Median age (years)  69 [60-79] 
Pathology  13 prostatectomy
1 ablatherm 
Previous urethral surgery 
Median time between surgery and TOMS (months)  21 [5-44] 
Median pad-test before TOMS (g)  175 [40-380] 
Median pad per day before TOMS  2 [1-3] 
Median time between TOMS and ProACT implantation  14.2 [3-65] 
Median pad-test before ProACT (g)  95 [15-330] 
Median pad per day before ProACT  1 [0-3] 


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