EUROPEAN UROLOGY 65 (2014) 502–507

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Letters to the Editor NOT referring to a recent journal article Comparative Study of AdVance and AdVanceXP Male Slings in a Tertiary Reference Center During the past 10 yr, innovative surgical options have been introduced to treat stress urinary incontinence (SUI) after radical prostatectomy (RP) [1]. Among these new devices, the retrourethral transobturator male sling (RTS) has rapidly become very popular and is now considered as a first-line option, challenging the supremacy of the artificial urinary sphincter [2]. The first version of the AdVance sling (American Medical Systems, Minnetonka, MN, USA) was launched in 2007 and has been studied extensively, with consistent reports in the urologic literature advocating for its sustainable efficacy and its low rate of complications [3]. However, the failure rate can be as high as 25% in the biggest case series published, without any clear explanations, even if some prognostic factors have been proposed to improve patient selection [3–5]. In mid-2010, a new version of the RTS, the AdVanceXP, was marketed and rapidly replaced the former AdVance sling in clinical practice. To our knowledge, no study has specifically compared these two devices in terms of efficacy and complications. Our objective was to compare the clinical outcomes obtained after midterm follow-up with the AdVanceXP sling with those obtained with the AdVance sling for management of SUI after RP. 1.

Material and methods

Since 2007, all patients treated by RTS in our tertiary reference center have been included in a noninterventional, prospective evaluation. Midterm outcomes after AdVance RTS implantation have already been published elsewhere [5]. Our goal was to produce the same evaluation for consecutive patients treated by AdVanceXP implantation and to compare the outcomes obtained with the two devices after similar follow-up. For the present work, we included all consecutive patients treated by AdVanceXP implantation for primary mild to moderate SUI after RP between July 2010 and May 2012. All procedures were done or supervised by the same surgeon (F.H.), according to a standardized technique that has been described elsewhere [6]. Preoperative evaluation was similar to our previous protocol [5]. Perioperative data and immediate complications

were recorded and classified according to Clavien-Dindo classification. Postoperative clinical visits were scheduled at 1, 3, or 6 mo and 12 mo and yearly thereafter. Patients living far away from the clinical center or not attending scheduled visits were contacted for a telephone interview by an independent practitioner to obtain postoperative data. Follow-up data included pad use, the Patient Global Impression of Improvement (PGI-I) questionnaire, and adverse events. Patients were considered cured if using no pads or a security pad, improved if using one pad or more but reduced pad use for more than 50%, and failed otherwise. Data were compared between AdVance (group 1) and AdVanceXP (group 2) using the chi-square test for quantitative variables and the Mann-Whitney test for quantitative variables. 2.

Results

From April 2007 to May 2012, 335 RTS implantations were done in our tertiary reference center. For the present analysis, 104 cases were excluded:10 had previous periurethral injection or balloon implantation, 24 were ‘‘redo’’ slings in previously failed patients, 29 were implanted in patients with SUI after benign prostate surgery, and 41 had no available data after 1-yr follow-up (4 died, 7 refused to attend follow-up evaluations, and 30 were lost to follow-up [13 in group 1 and 17 in group 2]). Patients characteristics were comparable between both groups (Table 1). After a follow-up of 21 mo (range: 16–26) and 16 mo (range: 12–25), the proportions of patients cured, improved, and failed were not significantly different between groups. A high proportion of patients were satisfied with the intervention (PGI-I of 1 or 2), in line with the results on pad usage. Immediate adverse events were limited to grade 1 complications in each group, with no cases of erosion, explantation, or infection. In group 1, two patients experienced transient urinary retention, one had perineal hematoma (treated with conservative management), and two had perineal paresthesia persisting for 6 mo. In group 2, two patients experienced transient urinary retention, and one had perineal hematoma conservatively managed. Late complications were only grade 1 (persistent perineal pain in 5% in group 1 vs 2% in group 2 and mild voiding

0302-2838/$ – see back matter # 2013 Published by Elsevier B.V. on behalf of European Association of Urology.

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EUROPEAN UROLOGY 65 (2014) 502–507

Table 1 – Patient characteristics and outcomes in both groups

Preoperative data Age, yr, mean  SD (range) Radiation therapy, n (%) Yes No Preoperative pad test, median (IQR) Preoperative pad use, median (IQR) Surgical management of anastomosis stricture, n (%) Yes No Years between RP and sling implantation, mean (range) Postoperative data Follow–up, mo, median (IQR) Status, n (%) Cured (no pads or pad use for security reasons) Improved (reduction of pad use >50%) Failed PGI–I, n (%) Very much better Much better A little better No change A little worse Much worse Very much worse

AdVance (n = 121)

AdVanceXP (n = 110)

p

66.7  6.5 (54–80)

66.6  6.9 (51–81)

0.887

16 105 100 2

(13) (87) (50–200) (1–3)

11 99 140 2

10 (8) 111 (90) 3.1 (1.8–5.1)

(10) (90) (80–200) (1–3)

0.446 0.15 0.923

12 (11) 98 (89) 3 (2–5)

0.82

21 (16–26)

16 (12–25)

0.01

76 (63) 19 (16) 26 (21)

65 (59) 19 (17) 26 (24)

0.84

62 27 17 17 2 1 0

75 13 9 11 1 0 1

0.08

(51) (22) (10) (14) (2) (1) (0)

(68) (12) (8) (10) (1) (0) (1)

0.494

IQR = interquartile range; PGI-I = Patient Global Impression of Improvement; RP = radical prostatectomy.

difficulties in 13% of patients in group 1 vs 12% in group 2) and grade 2 (anticholinergics treatment for three patients in group 2, after a urethrocystoscopy had excluded any erosion). 3.

Discussion

The second generation of the RTS was introduced in 2010 after the initial success of the AdVance male sling, providing additional features such as a redesigned sling, longer arms, and distinct tissue anchors with the hope of better procedural consistency and increased stability of the sling during the healing period after implantation. However, these minimal technical changes did not deeply modify the surgical technique and the underlying mechanism of action of the sling. The results presented in this paper show that efficacy of AdVance and AdVanceXP were similar in two comparable, homogeneous populations, with around 75% success in the short term. These data have been shown elsewhere to stand the test of time after 3-yr follow-up with the first generation of RTS [4], and a similar profile can reasonably be expected for the AdVanceXP device. Our results look similar in both groups but should be analyzed regarding several factors that could influence the outcome. First, all of the interventions were not done by the senior surgeon himself; 8 cases in the AdVance group and 12 in the AdVanceXP group were supervised by the expert ( p = 0.16). Preoperative pad test values were slightly higher in the AdVanceXP group ( p = 0.15; Table 1). These differences, although not significant, may partly explain why the results obtained with the second series were not

superior despite the experience gained by the surgeons with the AdVance sling before the use of the AdVanceXP sling (learning curves were included in the present data for both series). Our report has intrinsic limitations such as the lack of standardized, validated questionnaires about quality of life and rigorous 24-h pad test evaluations during follow-up. However, previous reports have shown that PGI-I (assessed in the present paper), 24-h pad weight, and International Consultation on Incontinence Questionnaire-Short Form were highly correlated to each other after male sling implantation [7]. Our postoperative evaluation focused on daily pad use to identify dry patients, and thus PGI-I makes sense. Another potential limitation is that these data come from a single center, with all procedures done or supervised by a single expert surgeon, which may not perfectly reflect everyday practice. Finally, our comparison is not randomized, but actually only the second generation of RTS is currently available and we never used both devices in the same period. 4.

Conclusion

In our experience, the first and second generations of the RTS provided comparable results, with a high success rate and few complications. Conflicts of interest: Jean-Nicolas Cornu received travel grants from Bard, Bouchara-Recordati, and EDAP-TMS and consultancies from GSK, Takeda, Biocompatibles-UK, and Pfizer. Francois Haab is a consultant for American Medical Systems. The other authors have nothing to disclose.

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EUROPEAN UROLOGY 65 (2014) 502–507

References

Form (ICIQ-SF) score, International Prostate Symptom Score (IPSS), and Post-Operative Patient Global Impression of Improvement (PGI-I)

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[2] Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN. The Jean-Nicolas Cornu* Jose´ Batista Da Costa

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Department of Urology, Tenon Hospital, Hopitaux Universitaires Paris-EST, Assistance Publique-Hoˆpitaux de Paris (AP-HP), University Paris VI,

turator retroluminal repositioning sling suspension: 3-year follow-

Paris, France

up. Eur Urol 2012;62:140–5. [5] Cornu JN, Se`be P, Ciofu C, Peyrat L, Cussenot O, Haab F. Mid-term

*Corresponding author. Urology Department, Tenon Hospital, 4 rue de la

[4] Rehder P, Haab F, Cornu JN, Gozzi C, Bauer RM. Treatment of

evaluation of the transobturator male sling for post-prostatectomy incontinence: focus on prognostic factors. BJU Int 2011;108: 236–40. [6] Cornu JN, Se`be P, Ciofu C, et al. The AdVance transobturator male

Chine, 75970 Paris Cedex 20, France. Tel. +331 56 01 64 95; Fax: +331 56 01 73 06. E-mail addresses: [email protected], [email protected] (J.-N. Cornu).

sling for postprostatectomy incontinence: clinical results of a prospective evaluation after a minimum follow-up of 6 months. Eur Urol 2009;56:923–7. [7] Twiss CO, Fischer MC, Nitti VW. Comparison between reduction in 24hour pad weight, International Consultation on Incontinence-Short

Evaluation of Prostate-specific Antigen Response Following Cessation of Abiraterone Acetate: Is There Evidence for a Withdrawal Syndrome? Recently, it was reported that cessation of abiraterone acetate (AA) is associated with a withdrawal syndrome in metastatic castration-resistant prostate cancer (mCRPC) [1]. Two case series found this syndrome occurs in 7% (4 of 66) and 15% (3 of 26) of mCRPC patients [2,3]. To further investigate the frequency with which an AA withdrawal response occurs, we conducted a retrospective audit of mCRPC patients treated with AA. Eligible patients [(Fig._1)TD$IG]met all of the following criteria: (1) cessation of AA due to

October 17, 2013 Published online ahead of print on October 30, 2013 http://dx.doi.org/10.1016/j.eururo.2013.10.028

progressive disease (biochemical, measurable or clinical), (2) at least one prostate-specific antigen (PSA) measurement 2 wk after ceasing AA, and (3) no new systemic therapy or radiotherapy between ceasing AA and PSA measurement. Two weeks was selected as the minimum interval time period between cessation of AA and initial PSA measurement because AA has an elimination half-life of approximately 10 h [4] and thus is eliminated by approximately 2 d after final dosing. Sixty-nine eligible patients were identified, and 51% had a biochemical response to AA, whereas 33% had no decline on AA. Median time from discontinuation of AA to first PSA measurement was 27 d (range: 14–77 d). Compared with

Fig. 1 – Prostate-specific antigen decline after cessation of abiraterone acetate. PSA = prostate-specific antigen.

Comparative study of AdVance and AdVanceXP male slings in a tertiary reference center.

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