Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis

Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis

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Review – Incontinence

Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis Kathrin Meisterhofer a, Sereina Herzog b, Karin A. Strini a, Luca Sebastianelli c, Ricarda Bauer d, Orietta Dalpiaz a,* a

Department of Urology, Medical University of Graz, Graz, Austria; b Institute for Medical Informatics, Statistics and Documentation, Medical University of

Graz, Graz, Austria; c Department of Neurorehabilitation, Research Unit for Neurorehabilitation South Tyrol, Hospital of Vipiteno, Vipiteno, Italy; d Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Munich, Germany

Article info

Abstract

Article history: Accepted January 9, 2019

Context: Male slings are recommended by the European Association of Urology guideline for the treatment of mild to moderate postprostatectomy incontinence. However, none of them has been proved to be superior to the others, and there are no defined guidelines to preference of a given sling model. Objective: To evaluate and compare the efficacy and safety of the different types of male slings in the treatment of postprostatectomy incontinence. Evidence acquisition: This systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. A systematic literature search in the databases of PubMed, Embase, and Cochrane using the keywords “incontinence,” “prostatectomy,” and “male sling/system” was conducted in June 2018. Studies in English with at least 15 patients and a minimum follow-up of 12 mo were included. As the primary endpoint, we assessed the cure rate of the different sling types. As secondary endpoints, we assessed the improvement rate, subjective cure rate, overall complication rate, explantation rate, risk factors for failure, and effect on patients’ quality of life. Evidence synthesis: The literature search identified 833 articles. A total of 64 studies with 72 patient cohorts were eligible for inclusion. Fixed slings were implanted in 55 (76.4%) of the patient cohorts. The objective cure rate varies between 8.3% and 87% (pooled estimate 0.50, 95% confidence interval [CI] 0.45–0.56, I2 = 82%). Subjective cure was achieved in 33–94.4%. Adjustable slings showed objective cure rates between 17% and 92% (pooled estimate 0.61, 95% CI 0.51–0.71, I2 = 88%). The subjective cure rate varies between 28% and 100%. In both types of slings, pain was the most common complication, but chronic painful conditions were really rare (1.3% in fixed slings and 1.5% in adjustable slings). The most common complication after pain was urinary retention in fixed slings, and infection and consequential explantation in adjustable slings. Conclusions: Both fixed and adjustable slings are beneficial for the treatment of postprostatectomy incontinence. Although adjustable slings might lead to higher objective cure rates, they might be associated with higher complication and explantation rates. However, at present, due to significant heterogeneity of the data, this cannot be said with certainty. More randomized controlled trials with long-term follow-up and the same definition for continence are needed. Patient summary: Fixed and adjustable slings are effective treatment options in mild to moderate postprostatectomy incontinence. © 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Associate Editor: Malte Rieken Keywords: Incontinence Male Meta-analysis Prostatectomy Slings

* Corresponding author. Department of Urology, Medical University of Graz, Auenbruggerplatz 5, Graz 8020, Austria. Tel.: 0043 316 385 82123; Fax: 0043 316 385 13550. E-mail address: [email protected] (O. Dalpiaz).

https://doi.org/10.1016/j.euf.2019.01.008 2405-4569/© 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

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1.

Introduction

Stress urinary incontinence is a side effect of radical prostatectomy that can significantly influence the quality of life. Several definitions exist for postprostatectomy incontinence (PPI), and different modalities have been used to assess, at different time windows, its incidence after the surgical procedure [1]. Thus, the reported incidence of PPI varies from 7% to 39.5% for open radical prostatectomy, from 5% to 33.3% for laparoscopic prostatectomy, and from 4% to 31% for robotic prostatectomy [2,3]. Several sling systems have been developed in the past years. These slings are recommended by the European Association of Urology guidelines for the treatment of mild to moderate stress urinary incontinence because of their effectiveness [4]. However, none these has been proved to be superior to the others, and there are no defined guidelines for preferring a given sling model. All slings are implanted via a perineal approach. However, they differ in terms of mechanism of action, anatomical positioning, and materials. Fixed slings are positioned under the posterior urethra and fixed by a retropubic or transobturatoric approach. The tension is adjusted during the surgery and cannot be readjusted postoperatively. In contrast, adjustable slings are positioned on the musculus bulbospongiosus and have the advantage that the tension of the sling can be adapted postoperatively [4]. The AdVance sling (Boston Scientific, USA), the I-Stop TOMS (CL Medical, France), as well as the Virtue male sling (Coloplast, Denmark) are retrourethral transobturator male slings. The InVance sling (American Medical Systems, USA) is a bone-anchored fixed male sling, which is, however, no longer available in the market. Other fixed male slings are the TiLOOP (pfm medical, Germany) and Surgimesh M-Sling (Aspide Medical, France). Adjustable slings are Argus classic and ArgusT (Promedon, Argentina), ATOMS (A.M.I., Austria), and Remeex (Neomedic, Spain). They improve continence by producing pressure on the bulbar urethra and, to a lesser extent, on the membranous urethra [5]. To date, no study has systematically reviewed the literature on the different techniques for the treatment of PPI using slings. Furthermore, a meta-analysis on the data provided by the different clinical studies is still lacking. Therefore, the choice of a sling model for a given patient cannot be evidence based. Our aim was to evaluate and compare the efficacy and safety of the different types of slings, and identify risk factors for failures or secondary surgery after sling. Furthermore, we wanted to assess whether one sling type is better than the others. 2.

Evidence acquisition

This systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines [6]. 2.1.

Literature search

A systematic literature search in the databases of PubMed, Embase, and Cochrane using the keywords “incontinence,”

“prostatectomy,” and “male sling/system” was conducted in June 2018. The full search strategy of each database is presented in the Supplementary material. The search was limited to studies in English and with abstracts. Additionally; reference lists of the included publications and identified reviews were checked for any other relevant articles. 2.2.

Study selection

After exclusion of duplicates, two reviewers (K.M. and O.D.) independently screened the abstracts to identify potentially eligible studies. Prospective, retrospective, and randomized controlled studies with at least 15 patients with PPI and a minimum follow-up of 12 mo were included. One of the following outcomes had to be reported: success rate, cure rate, improvement rate, failure rate, subjective cure rate, complications, risk factors, or quality of life. Case and meeting reports and studies in which autologous slings had been implanted were excluded. One author (K.M.) reviewed the full-text articles for eligibility and another author (O.D.) controlled the final selection. Disagreements were resolved by discussion, and when no agreement could be reached, a third reviewer (S.H.) was consulted to reach a consensus. If multiple studies reported on the same or overlapping patient cohort, we selected studies in descending order: the study with the longest follow-up, the biggest patient group, and the most outcomes handled. 2.3.

Data extraction

The following data were extracted by one reviewer (K.M.): study characteristics (author, journal, year of publication, title, study design, clinic, type of sling, time recruitment, number of patients, patients age, and follow-up), outcomes including outcome definition where applicable (success rate, cure rate, improvement rate, failure rate, subjective cure rate, complications, risk factors, and quality of life), and additional information (type and severity of incontinence, use of pad tests, previous radiotherapy, previous incontinence surgery, intraoperative complications, use of ClavienDindo classification, number and reasons for explanations, and number of adjustments). The database was monitored thoroughly by another reviewer (O.D.). 2.4.

Data synthesis and analysis

As a primary endpoint, we assessed the objective cure rate of the different sling types. As the definition of cure overlapped with the definition of success in the included studies, we summarized the definitions for the meta-analysis. As secondary endpoints, we assessed the improvement rate, subjective cure rate, overall complication rate (OCR), explantation rate, risk factors for failure, and effect on patients’ quality of life. The meta-analysis was performed for the objective cure rate, OCR, and explantation rate using random-effect models for proportions, separately for fixed and adjustable slings. Sensitivity subgroup analyses were performed for severity of incontinence (I–II, I–III/II–III/III, unknown), sling

Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

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type (fixed slings: AdVance vs not AdVance; adjustable slings: all five sling types), follow-up (24, 24–36, 36–48, and 48 mo), and different outcome definitions where applicable. Another sensitivity analysis was performed by excluding the two cohorts from the only randomized controlled trial; only the outcome objective cure was presented therein. Heterogeneity of effect sizes across studies was assessed using I2 statistics. All analyses were performed using the statistical software R (version 3.4.4) with function metaprop in the package meta (version 4.9-2) [7,8]. 3.

Evidence synthesis

3.1.

Literature search

Idenficaon

The search in the databases identified 833 articles. With the removal of 158 duplicates and exclusion of 563 papers after

Records idenfied through database searching (n = 833) PubMed (n = 393) Embase (n = 360) Cochrane (n = 80)

screening the abstracts, full texts of 112 articles were reviewed. Subsequently, 54 articles were excluded. Six studies were included after checking the reference lists. Finally, 64 studies with 72 patient cohorts were included in the meta-analysis synthesis [9–72]. Figure 1 shows the detailed study selection process. 3.2.

Characteristics of included studies

Characteristics of the included 64 studies with the 72 patient cohorts are described in Table 1. The study design was prospective in 20/64 (31.3%), and 13/64 (20.3%) were multicentric. The median follow-up ranged from 12 to 58 mo [9,41]. As eight studies compare different types of slings or groups of patients, the different cohorts are shown separately by adding a and b to the study numbers in all tables and figures. Therefore, the following numbers and

Addional records idenfied through other sources (n = 6)

Screening

Records aer duplicates removed (n = 675)

Records screened (n = 112)

Records excluded (n = 563)

Full-text arcles excluded (n = 54) Eligibility

3

Full-text arcles assessed for eligibility (n = 58)

30 same paent group 10 review/arcle/ comment on arcle 6 follow-up <12 mo 4 full text not in English 2 examinaon (urodynamic, MR, sono) 1 autologous sling 1 sling and AUS are implanted, and AUS is acvated to achieve connence

Included

Studies included in qualitave synthesis (n = 64, with 72 paent cohorts)

Studies included in quantave synthesis (meta-analysis) (n = 64, with 72 paent cohorts) Fig. 1 – Flow diagram for study selection.

Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

No.

Study author

Study design

Time of recruitment

Sling

Follow-up (mo) Median (range)

Patients Number

Mean (SD)

OC

SC

QoL

C

RF













Age (yr) Median (range) Mean (SD)

Barnard et al (2014) [9]

2

Bauer et al (2017) [10]

3

Berger et al (2011) [11]

4a*

Chung et al (2016) [12]

5

Collado Serra et al (2013) [13]

6

Cornel et al (2010) [14]

7

Cornu et al (2011) [15]

8

Grimsby et al (2012) [16]

9

Habashy et al (2016) [17]

10

Kowalik et al (2015) [18]

11

Leruth et al (2012) [19]

12

Li et al (2012) [20]

13a*

Lima et al (2016) [21]

14

Papachristos et al (2018) [22]

15

Rehder et al (2012) [23]

16a*

Sturm et al (2014) [24]

16b*

Sturm et al (2014) [24]

17

Suskind et al (2011) [25]

18

Torrey et al (2013) [26] *

19a

Wright et al (2017) [27]

19b*

Wright et al (2017) [27]

20

Zuckerman et al (2014) [28]

– Monocentric Prospective Multicentric Retrospective Monocentric Prospective Monocentric – Monocentric Prospective Multicentric Prospective Monocentric Retrospective Monocentric Retrospective Monocentric Retrospective Monocentric Prospective Monocentric – Monocentric Randomized Prospective Monocentric – Monocentric Prospective Multicentric Retrospective Multicentric Retrospective Multicentric Retrospective Monocentric Retrospective Monocentric Retrospective Monocentric Retrospective Monocentric Retrospective Monocentric

05.2007– 11.2012 01.2012– 03.2016 –

AdVance

12

46

AdVance XP

36

115

AdVance

26

01.2009– 12.2011 02.2008– 06.2011 09.2007– 06.2008 04.2007– 06.2009 09.2008– 06.2010 2008– 2013 02.2008– 03.2010 04.2006– 04.2011 05.2007– 12.2009 12.2010– 12.2011

AdVance

22 (10–27) 33.1 (24–46) 26 (12–53) 12 21 (6) 12.8 (6.2–26.5) 36 (14–72) 39 (IQR 36–44) 24 (12–60) 23.8 (16.9–28.4) 18

136

2008– 2014 02.2006– 03.2008 2006– 2012 2006– 2012 – 04.2008– 06.2010 2007– 2017 2007– 2017 08.2006– 06.2012

AdVance/ AdVance XP AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance

AdVance AdVance AdVance Ideal pat. group AdVance Not ideal pat. group AdVance AdVance AdVance, XRT AdVance, no XRT AdVance

52 (18–89) 39 (IQR 37–42) 28 (12–49) 29 (12–51) 18.8 (1–40) 17.3 (IQR 7.1–25) 61.5 (33–92) 61.5 (33–92) 33.8 (12.1–71.7)

19 61 36

31 50 30 173 56 11

86 156 72 23 42 37 14 22 102

64.8 (45–83) 69 (47–82) 67 (52–79) 63.8 (48–72) 65 (56–83) 68.5 (55–82.6) 67.4 (6.8) 71 (49–85) 67.5 (52–82) 68 (IQR 62–70) 69 (46–83) 67 – –



67 (54–86) 68 (IQR 63–72) 64.8 (51–79) 67 (52–85) 63.6 (51–82) 68 (IQR 62–71) 69.8 (55–81) 69 (54–86) 66.1 (9.3)

















































 

 



 







































 



















 























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Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

Table 1 – Study characteristics.

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No.

Study author

Study design

Time of recruitment

Sling

Follow-up (mo) Median (range)

Patients Number

Mean (SD)

OC

SC





QoL

C

RF





Age (yr) Median (range) Mean (SD)

21

Athanasopoulos et al (2010) [29]

22

Ballert and Nitti (2010) [30]

23

Carmel et al (2010) [31]

24

Castle et al (2005) [32]

25

Comiter (2005) [33]

26

Fischer et al (2007) [34]

27

Gallagher et al (2007) [35]

28

Giberti et al (2009) [36]

29

Guimaraes et al (2009) [37]

30

Styn et al (2011) [38]

31

Yiou et al (2016) [39]

32

Galiano et al (2016) [40]

33

Malval et al (2017) [41]

34

Le Portz et al (2016) [42]

35

Sacco et al (2018) [43]

36a*

Comiter et al (2014) [44]

36b*

Comiter et al (2014) [44]

37

Ferro et al (2017) [45]

38

McCall et al (2016) [46]

39

Rajpurkar et al (2005) [47]

40a*

Samli and Singla (2005) [48]

40b*

Samli and Singla (2005) [48]

41a*

Dikranian et al (2004) [49]

Retrospective Monocentric Prospective Monocentric Prospective Monocentric Retrospective Monocentric – Monocentric Prospective Monocentric – Monocentric Retrospective Monocentric Case series Monocentric Retrospective Monocentric Prospective Monocentric Prospective Monocentric Retrospective Multicentric Prospective Multicentric Prospective Monocentric Prospective Multicentric Prospective Multicentric Prospective Monocentric Retrospective Monocentric Retrospective Monocentric – Monocentric – Monocentric – Monocentric

02.2004– 11.2006 04.2002– 02.2007 09.2003– 12.2008 03.2002– 10.2003 03.2000– 04.2003 04.2002– 12.2005 10.2002– 05.2005 12.2002– 12.2007 07.2003– 07.2007 05.2000– 05.2009 01.2010– 01.2012 03.2012– 03.2015 06.2007– 05.2012 12.2010– 05.2012 01.2013– 06.2016 –

InVance InVance InVance InVance InVance InVance InVance InVance InVance InVance (Till 2006 Pelvicol Mesh) TOMS I-Stop TOMS I-Stop TOMS Surgimesh M-Sling TiLOOP Virtue



Virtue fixed

07.2012– 10.2013 10.2009– 01.2012 05.2001– 04.2004 2001– 2004 2001– 2004 05.2001– 10.2002

Virtue Virtue Self-made bone fixed Different materials Self-made bone fixed Not absorbable Self-made bone fixed Absorbable Self-made bone fixed Silicone

24.2 (4–38) 16.5 (3–58) 36 (2–64) 18 (6–26) 48 (24–60) 12 (3–37) 15 (9–21) 35.2 (2–62) 28 – 13 (0.5–72) 24 – 12 – 58 (19–78) 24 25 (12–55) 12 – 12 – 14.5 (12–22) 55 (30–69) 24 (6) 18.9 (6.3) 28.8 (3.4) 14 (12–16)

43 72 45 38 48 62 31 40 62 119 40 52 100 93 44 98 31 29 32 46 27 12 16

68.1 (21–90) 67.3 (45–84) 68 (6.3) 71.6 (55–90) 67.6 (9.7) 67.2 (45–84) 66 (54–83) 66 (6.3) 69 (57–78) 65.8 (23–89) 67.7 (7) 64.9 (5.1) 68 (54–82) 72.55 (60–88) 69.6 (5.7) 67 (48–87) 66.2 (56–79) 65.5 (4.75) 72 (64.5–77) 71 – 67.8 (8.1) 65.9 (10.1) 62.8 (63–76)

 

 





 















































 

 





















 





























 

























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Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

Table 1 (Continued )



5

No.

Study author

Study design

Time of recruitment

Sling

Follow-up (mo) Median (range)

Patients Number

Mean (SD)

OC

SC

QoL

C

RF











Age (yr) Median (range) Mean (SD)

41b*

Dikranian et al (2004) [49]

42

Madjar et al (2001) [50] Crites et al (2011) [51]

*

43b

Crites et al (2011) [51]

44

John and Blick (2008) [52]

45

Migliari et al (2006) [53]

46

Schaeffer et al (1998) [54]

47

Wadie (2010) [55]

48

Wu et al (2017) [56]

49

Xu et al (2007) [57]

50

Bochove-Overgaauw and Schrier (2011) [58]

4b*

Chung et al (2016) [12]

51

Dalpiaz et al (2011) [59]

52

Hubner et al (2011) [60]

53

Miodrag et al (2014) [61]

54

Bauer et al (2015) [62]

55

Cornel (2016) [63]

13b*

Lima et al (2016) [21]

56

Siracusano et al (2017) [64]

57

Angulo et al (2017) [65]

58

Friedl et al (2017) [66]

59

Krause et al (2014) [67]

05.2001– 10.2002 –

Self-made bone fixed Pelvicol Self-made bone fixed

2000– 2001 2000– 2001 –

Bone-fixed sling

10.1999– 10.2002 08.1992– 11.1996 – 12.2005– 11.2015 05.2000– 04.2005 04.2005– 10.2006 01.2009– 12.2011 10.2006– 07.2007 04.2005– 04.2009 02.2010– 02.2014 01.2011– 02.2012 01.2012– 09.2014 12.2010– 12.2011 06.2008– 03.2013 09.2014– 11.2015 06.2009– 03.2016 04.2010– 04.2010

Transobturatoric sling Self-made Self-made Self-made Self-made Self-made Self-made Argus classic Argus classic Argus classic Argus classic Argus classic Argus T Argus T Argus T

Argus T ATOMS ATOMS ATOMS

18 (14–29) 13 (4–20) 43.2 (2–95) 14.6 (3–33) 36 (3–74) 32 (26–48) 18.1 (6.5–53.8) 24 – 36.9 [29.4) 28.3 (8–54) 27 (14–57) 36.2 (24–48) 35 (29–45) 26.4 (1.2–54) – (6–48) 28.5 (20–38) 12 – 18

22 (1–59) 18.5 (12–26) 31 (10–54) 30 (9–52)

20 16 30 30 57 49 64 40 31 26 100 25 29 101 20 42 36 11

182 34 287 36

64.8 (56–78) 67 (56–74) 68.9 (10.8) 70.4 (7.94) 67 (42–83) 70.5 (65–75) 67.9 (55.4–78.7) 66 (20–80) 59.5 (18.9) 65.5 (18–81) 66 (50–89) 65.4 (47–76) 71 (61–79) 69.6 (51–84) – (57–76) 67.4 (53–79) 69.4 (7.2) –

71 (50–86) 70.5 (48–79) 70 (66–74) 70.42 (50–79)



































 







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43a*

– Monocentric – Monocentric Retrospective Monocentric Retrospective Monocentric – Monocentric – Monocentric – Multicentric – Monocentric Retrospective Monocentric Prospective Monocentric Retrospective Monocentric Prospective Monocentric Retrospective Monocentric – Monocentric Retrospective Monocentric Prospective Multicentric Prospective Monocentric Randomized Prospective Monocentric – Multicentric Retrospective Monocentric Retrospective Multicentric – Monocentric

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Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

Table 1 (Continued )

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19

21

Self-made Adjustable Self-made Adjustable Self-made Adjustable

Sousa-Escandon et al (2007) [69]

Altan et al (2017) [70]

Balci et al (2015) [71]

Inci et al (2008) [72]

61

62

63

64

C = complications; IQR = interquartile range; OC = objective cure; QoL = quality of life questionnaire; RF = risk factors; SC = subjective cure; SD = standard deviation; XRT = radiotherapy;  = shown in study;  = not given. Studies 4, 13, 16, 19, 36, 40, 41, and 43 compared different slings or patient groups, so they are shown separately.





 58

51 Remeex

Remeex

01.2007– 01.2014 10.2002– 08.2005 05.2005– 08.2013 09.2007– 05.2013 05.2005– 06.2006 – Multicentric Prospective Multicentric – Monocentric Prospective Monocentric – Monocentric Kim et al (2016) [68] 60

*



  





 

70 (53–84) 69 (58–81) 67.6 (7,8) 66.2 (7.3) 67.5 (59–80)

Age (yr)

Mean (SD)

64

46 (19.47) 32 (16–50) 48 (29) 40.1 (23.2) 17.3 (12–25)

Mean (SD)

Median (range)

Number

Median (range)



OC Patients Follow-up (mo) Sling Time of recruitment Study design Study author No.

Table 1 (Continued )



C SC

QoL





RF

E U RO P E A N U RO L O GY F O C U S X X X ( 2 018 ) X X X– X X X

7

percentages refer to a total number of 72 patient cohorts. Fixed slings were implanted in 55/72 (76.4%) patient cohorts [9–57] and adjustable slings were implanted in 17/72 (23.6%) patient cohorts. 3.3.

Efficacy of the slings

3.3.1.

Definitions

Objective cure was reported for 64/72 (88.9%) patient cohorts. Success was reported in 36/72 (50%), where eight different definitions were used for it. Cure was given in 57/ 72 (79.2%) patient cohorts where nine different definitions were used. For the objective cure rate we used for the metaanalysis, the definition “no pad usage” was used in 27/72 (37.5%), “socially continent” in 34/72 (47.2%), and “very much better or much better in Patient Global Impression of Improvement (PGI-I)” in 2/72 (2.8%) cases, and in one case no definition was given (Table 2). “Social continent” was defined as usage of zero to one security pad per day or minimal leakage in pad test. Early postoperative pain was defined as pain that resolved within the first 3 mo after sling implantation. 3.3.2.

Fixed slings

Fixed slings were implanted in 55/72 (76.4%) patient cohorts and overall in 2887 published patients (1344 AdVance, 560 InVance, 192 TOMS/I-Stop TOMS, 93 Surgimesh M-Sling, 44 TiLOOP, 190 Virtue, and 464 other/self-made fixed slings). The objective cure rate varies between 8.3% (1/12) and 87.5% (14/16) in individual cohorts. For all the 47 cohorts combined, the pooled proportion estimate of objective cure was 0.50 (95% confidence interval [CI] 0.45–0.56; see Fig. 2A). Based on the Q test (p < 0.01) and Higgins I2 statistics (I2 = 82%), substantial heterogeneity was present. The most implanted fixed sling is the AdVance sling (30.6%). Its objective cure rate ranges between 9% (3/33) and 87% (40/46). Study number 15 has one of the largest patient cohorts. Eighty patients out of 151 (53%) were cured at a median follow-up of 39 mo after implantation of an AdVance sling [23]. The objective cure rates achieved were only 14.3% (3/21) and 33.3% (10/32) in studies 33 and 38, respectively, where I-Stop TOMS and Virtue slings were implanted. Notably, the median followup of these studies was up to 58 and 55 mo, respectively [41,46]. Lower objective cure rates were also noted in studies 40b and 41b, where absorbable slings were implanted [48,49]. 3.3.3.

Adjustable slings

Adjustable slings were implanted in 17/72 (23.6%) cohorts and overall in 1116 published patients (275 Argus classic, 271 Argus T, 357 ATOMS, 115 Remeex, 98 other/self-made adjustable slings). The objective cure rate ranges between 17% (5/29) and 92% (23/25) in individual cohorts. The pooled proportion estimate of objective cure was 0.61 (95% CI 0.51– 0.71)—higher than in fixed slings, but the 95% CI overlap was significant (Fig. 2B). High heterogeneity was also observed here with I2 = 88% (Q test, p < 0.01). The most implanted adjustable sling is the Argus classic sling (5/17, 29.4%), but it

Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

No.

Author

Sling

Pat Severity of incontinence Objective cure n (%)Def

N Barnard et al (2014) [9] Bauer et al (2017) [10] Berger et al (2011) [11] Chung et al (2016) [12] Collado Serra et al (2013) [13] Cornel et al (2010) [14] Cornu et al (2011) [15] Grimsby et al (2012) [16] Habashy et al (2016) [17] Kowalik et al (2015) [18] Leruth et al (2012) [19] Li et al (2012) [20] Lima et al (2016) [21] Papachristos et al (2018) [22] Rehder et al (2012) [23] Sturm et al (2014) [24] Sturm et al (2014) [24] Suskind et al (2011) [25] Torrey et al (2013) [26] Wright et al (2017) [27]

19b

Wright et al (2017) [27]

20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36a 36b 37 38 39

Zuckerman et al (2014) [28] Athanasopoulos et al (2010) [29] Ballert and Nitti (2010) [30] Carmel et al (2010) [31] Castle et al (2005) [32] Comiter (2005) [33] Fischer et al (2007) [34] Gallagher et al (2007) [35] Giberti et al (2009) [36] Guimaraes et al (2009) [37] Styn et al (2011) [38] Yiou et al (2016) [39] Galiano et al (2016) [40] Malval et al (2017) [41] Le Portz et al (2016) [42] Sacco et al (2018) [43] Comiter et al (2014) [44] Comiter et al (2014) [44] Ferro et al (2017) [45] McCall et al (2016) [46] Rajpurkar et al (2005) [47]

40a Samli and Singla (2005) [48] 40b Samli and Singla (2005) [48] 41a Dikranian et al (2004) [49]

AdVance AdVance XP AdVance AdVance AdVance/Advance XP AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance XRT AdVance no XRT AdVance InVance InVance InVance InVance InVance InVance InVance InVance InVance InVance TOMS I-Stop TOMS I-Stop TOMS Surgimesh M-Sling TiLOOP Virtue Virtue fixed Virtue Virtue Self-made bone fixed, different materials Self-made bone fixed, not absorbable Self-made bone fixed, absorbable Self-made—silicone

#

Cure n (%)Def

b

Improvement n (%)Def

Failure n (%)Def I

Subjective cure n/N (%)

– – – 106 (78)a 24 (77)h – – 114 (84)a 35 (62.5)a – – – – – – 29 (78.4)a –

– 31 (66)5 16 (61.5)1 16 (84)3 49 (80)1 3 (9)4 84 (61.8)1 – – 18 (60)2 66 (49)1 22 (39.3)1 5 (45.5)3 37 (51)2 80 (53)2 36 (50)1 5 (22)1 – 19 (51.4)1 –

– 11 (23.4)d 7 (26.9)b – 5 (8)d 15 (45.5) 22 (16.2)a – – 4 (13)a 48 (35)g 13 (23.2)b – 18 (25)a 36 (23.8)g – – – 10 (27)z –

6 (13.1) 5(10.6)I 3 (11.5)I – 7 (12)I 15 (45.5)IV 30 (22)I – – 8 (27)IV 22 (16)I – – 17 (24)IV 35 (23.2)IV – – – 8 (21.6)V –

– – 21/24 (87.5) x – 18/33 (54.5) – – – – 98/136 (72) 30/56 (53.6) 4/11 (36.4) 57/72 (79) – 66/72 (92) 7/23 (30) 34/36 (94.4) – 2/6 (33)











8/10 (80)

III I–III – II–III I–III – – I–III III I–III – – I–II I–II II–III I–III I–III I–III I–II – I–III

41 (40)# 22 (51.2)# 48 (66.7)+ 16 (36)* 6 (15.8) * 31 (65)* 21 (34)* 9 (38)* 22 (55)# 21 (70)* – 15 (45.5)# 18 (52.9)* 3 (15)* – 24 (54.5)# 15 (15)# 14 (46)# – 10 (32) 17 (37)*

63 (62)a – 48 (66.7) g 34 (76)a 15 (39.5)c – 36 (58)g 18 (75)c – 27 (90)a – 15 (45.5)b 28 (82.4)b 3 (15)d – 34 (77.3)a 41 (41.9)f 25 (79.2)f – 10 (32) 34 (74)a

41 (40)2 22 (51.2)3 – 16 (36)1 6 (15.8)1 31 (65)1 21 (34)1 9 (38)1 22 (55)7 21 (70)1 – – 18 (52.9)1 – – (34.4)4 24 (54.5)2 15 (15)6 14 (46)6 – – 17 (37)1

22 (22)e 8 (18.6)e – 18 (40)b – 10 (20)u – – 5 (12.5)h 6 (20)e – – 25 (73.5)a 2 (7)a – (27.1)d 10 (22.7)g – – – – 17 (37)b

– 13 (30.2)III 24 (33.3)VI 11 (24)III – 7 (15)VII 26 (42)VI – 13 (32.5)V 3 (10)I – – – 16 (78)IV – (19.4)I 10 (22.7)I – – – 21 (68)IV 12 (26)III

– 30/43 (69.6) – 32/45 (72) – – – 18/24 (75) – 50/62 (81) – – – – – 33/44 (75) 41/98(41.9) 22/31 (70.9) –

I–III I–III –

15 (55.6)* 1 (8.3)* 14 (87.5)#

26 (96.2)b 1 (8.3)b –

15 (55.6)1 1 (8.3)1 14 (87)2

11 (40.7)g 0 (0)g 2 (13)a

1 (3.7)III 11 (91.7)III 0 (0)II

– – –

46 47 26 19 61 33 136 31 – 30 136 56 11 72 151 72 23 36 37 6

I–III – – – – I–III I–II – – I–III I–III – – I–III I–III I–II III – – –

40 (86.9) 31 (66)# 16 (61.5)* 16 (84)# 49 (80)* 3 (9)# 84 (61.8)* 24 (77)+ – 18 (60)# 66 (49)* 22 (39.3)* 5 (45.5)# 37 (51)# 80 (53)# 36 (50)* 5 (22)* – 19 (51.4)* –

10



102 43 72 45 38 48 62 24 40 30 – 33 34 21 77 44 98 31 29 32 46 27 12 16

40 (86.9) –

32/46 (70)

E U R O P E A N U R O L O GY F O C U S X X X ( 2 0 18 ) X X X– X X X

1 2 3 4a 5 6 7 8 9 10 11 12 13a 14 15 16a 16b 17 18 19a

Success n (%)Def

EUF-659; No. of Pages 18

8

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Table 2 – Efficacy.

EUF-659; No. of Pages 18

No.

Author

Sling

Pat Severity of incontinence Objective cure N

41b 42 43a 43b 44 45 46 47 48 49 50 4b 51 52 53 54 55 13b 56 57 58 59 60 61 62 63 64

Dikranian et al (2004) [49] Self-made—Pelvicol Madjar et al (2001) [50] Self-made bone fixed Crites et al (2011) [51] Bone-fixed sling Crites et al (2011) [51] Transobturatoric sling John and Blick (2008) [52] Self-made Migliari et al (2006) [53] Self-made Schaeffer et al (1998) [54] Self-made Wadie (2010) [55] Self-made Wu et al (2017) [56] Self-made Xu et al (2007) [57] Self-made Bochove-Overgaauw D and Schrier (2011) [58] Argus classic Chung et al (2016) [12] Argus classic Dalpiaz et al (2011) [59] Argus classic Hubner et al (2011) [60] Argus classic Miodrag et al (2014) [61] Argus classic Bauer et al (2015) [62] Argus T Cornel 2016) [63] Argus T Lima et al (2016) [21] Argus T Siracusano et al (2017) [64] Argus T Angulo et al (2017) [65] ATOMS Friedl et al (2017) [66] ATOMS Krause et al (2014) [67] ATOMS Kim et al (2016) [68] Remeex Sousa-Escandon et al (2007) [69] Remeex Altan et al (2017) [70] Self-made adjustable Balci et al (2015) [71] Self-made adjustable Inci et al (2008) [72] Self-made adjustable

16 16 30 30 57 49 64 40 31 25 95 25 29 101 20 42 35 9 182 34 287 36 64 51 45 21 19

– – – – – I–III III III II–III I–III I–III – I–III II–III II–III – – – I–III I–III I–III II–III I–III I–III I–III I–III III

Success

Cure

Improvement

Failure

Subjective cure

n (%)Def

n (%)Def

n (%)Def

n (%)Def

n (%)Def

n/N (%)

9 (56)# 12 (75)# 4 (13.3)* 12 (40)* 34 (60)# 15 (30)* 36 (56)* 34 (85)* – 18 (72)# 38 (40)# 23 (92)# 5 (17)# 80 (79.2)# 18 (90)* 26 (61.9)# 18 (51.4)# 7 (77.8)# 60 (33)# 29 (85.3)# 184 (64)# 14 (38.9)# 39 (60.9)# 33 (64.7)# 17 (37.8)* 16 (76.2)# 15 (78.9)*

– – 11 (36.6)a 23 (76.7)a 42 (74)a 31 (63)b 41 (64)a – – 23 (92)a 68 (72)a – – – – – 29 (82.9)a – 157 (86.2)a – 258 (90)e

9 (56)2 12 (75)2 4 (13.3)1 12 (40)1 34 (60)2 15 (30)1 36 (56)1 34 (85)1 – 18 (72)3 38 (40)2 23 (92)3 5 (17)2 80 (79.2)7 18 (90)9 26 (61.9)5 18 (51.4)4 7 (77.8)3 60 (33)3 29 (85.3)2 184 (64) 8 14 (38.9)2 39 (60.9)2 – 17 (37.8)1 16 (76.2)2 15 (78.9)1

5 (31)a 4 (25)a 7 (23.3)a 11 (36.7)a 8 (14)b – 5 (8) g – – 5 (20)b 30 (32)g – – – – 11 (26.2)d 11 (31.4)d – 97 (53.2)d 3 (8.8)b – 4 (11.1)b 7 (10.9)g 10 (19.6)a 13 (28.9)b 3 (14)b 2 (10.5)b

2 (13)II – 19 (63.3)V 7 (23.3)V 15 (26)VIII – 23 (36) I – – 2 (8)I – – – – 2 (10)IX 5 (11.9)I 6 (17.1)IV – – 2 (5.9)III – 19 (52.8)III 18 (28.1)I 8 (15.7)II 15 (33.3) 2 (9.8)III 2 (10.5)III

– – – – – – – – 27/31 (87) – 68/100 (68) x 8/29 (28) – – – 32/35 (91.5) 9/9 (100) – 33/34 (97) – 16/34 (47) – 43/51 (84.3) – – –

46 (71.9)a 33 (64.7) b 30 (66.7) a – –

Pat = number of patients who were included in the results; PGI-I = Patient Global Impression of Improvement; PPD = pads per day; XRT = radiotherapy;  = not given. Data that were not given in the study have been calculated afterward and are highlighted in red in the table. Severity of incontinence: I, mild incontinence—<3 PPD; II, moderate incontinence—3–5 PPD; III, severe incontinence—>5 PPD. Objective cure: these data were used for meta-analysis; *, no pad usage (d, 1, 9); #, social continence (b, c, 2, 3, 4, 5, 6, 7, 8); +, “very much better” or “much better” in PGI-I (g, h). Success: a, cure and improvement; b, 0–1 security pad/d; c, 0–1 PPD; d, no pad usage; e, improvement in daily pad test and pad use; f, 50% improvement in pad weight; g, “very much better” or “much better” in PGI-I; h, “very much better” or “much better” on PGI-I and lack of stress urinary leakage on postoperative physical examination. Cure: 1, no pad usage; 2, 0–1 security pad/d; 3, 0–1 PPD; 4, no pad usage and <2 g urine loss daily; 5, 0–5 g in 24-h pad test and no pad usage; 6, <1.3 g in pad test; 7, 0–1 g pad weight; 8, <10 ml/d urine loss and 0–1 PPD; 9, negative/dry pad test. Improvement: a, 50% reduction in the number of pad use; b, 1–2 PPD; g, daily use 2 PPD and reduced by at least 50%; d, >50% reduction of urine loss in 24-h pad test; e, 50% reduction in pad use and patient satisfaction; z, reduction in the number of pads; h, pad weight 2–50 g; u, postoperative leakage is a “small” or “moderate problem." Failure: I, all other outcomes; II, <50% reduction in the number of pad use; III, >2 PPD; IV, not improved or patients requiring additional procedures; V, unchanged or worse; VI, little better, “no change,” “a little worse,” or “much worse” in PGI-I; VII, complained of a “big problem”; VIII, no decrease of pads or no improvement in quality of life, improvement after operation but re-onset of symptoms after treatment; IX, positive pad test. Subjective cure: x, the subjective cure rate on a five-point scale was 4.5 in Argus and 4.3 in AdVance patients.

E U RO P E A N U RO L O GY F O C U S X X X ( 2 018 ) X X X– X X X

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Table 2 (Continued )

9

EUF-659; No. of Pages 18 10

E U R O P E A N U R O L O GY F O C U S X X X ( 2 0 18 ) X X X– X X X

Fig. 2 – Study characteristics.

has been replaced by the updated version, the Argus T sling (4/17, 23.5%). The objective cure rate of the Argus T sling ranges between 33% (60/182) and 77.8% (7/9). The failure rate (52.8% [19/36]) after implantation of Argus T slings in study 59 was higher than for all other adjustable slings.

However, in contrast to the other studies, all sling explantations were integrated in the failure rate [67]. Study 58 had the biggest patient cohort; 184 patients out of 287 (64.1%) were cured at a median follow-up of 31 mo after implantation of an ATOMS system [66]. The longest follow-up was

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EUF-659; No. of Pages 18 E U RO P E A N U RO L O GY F O C U S X X X ( 2 018 ) X X X– X X X

noted in study 62, where self-made adjustable slings were implanted. At a mean follow-up of 48 mo, 37.8% (17/45) of patients were cured [70]. 3.4.

Complications

The most reported complications of sling implantation are shown in Table 3. Almost all patient cohorts (97.2%) reported complications. The Clavien-Dindo classification was used in 22/72 (30.6%) cases. The OCR was reported only in 14 of 55 (25.5%) cohorts with fixed slings and in five 5 of 17 (29.4%) cohorts with adjustable slings (overall in 26.4% of the cohorts). The OCR of the two most implanted slings (AdVance and Argus) ranged between 2–13.6% and 4– 83%. The OCR was higher for adjustable slings than for fixed slings, but there was considerable 95% CI overlap (0.26, 95% CI 0.08–0.61, I2 = 95% vs 0.18, 95% CI 0.10–0.29, I2 = 88%); (Fig. 3A and 3B). Postoperative pain was the most reported complication (58/72 [80.6%. In most of these cohorts, patients suffered from early postoperative pain. In only 19/72 (26.4%) cohorts (13 fixed, six adjustable), pain did not resolved within the first 3 mo. Overall 37/2887 (1.3%) patients with fixed slings and 17/1116 (1.5%) patients with adjustable slings suffered from chronic pain. In 10 (13.8%) cohorts, one or more slings (1/560 [0.2%] InVance, 1/190 [0.5%] Virtue, 5/546 [0.9%] Argus, 2/357 [0.6%] ATOMS, 1/115 [0.9%] Remeex, and 1/98 [1%] self-made adjustable sling) had to be explanted due to persistent and/or severe pain. Urinary retention was the most common complication after pain in fixed slings and was reported in 67.3% (37/55) of patients. Infection and consequential explantation were the most common complications after pain in adjustable slings and were reported in 14/17 (82.4%) cases. Explantation rate varies from 0.6% to 22% in fixed slings and 9.3% to 35% in adjustable slings in individual cohorts. The pooled analysis showed a higher explantation rate in adjustable slings (0.14, 95% CI 0.10–0.18, I2 = 64% vs 0.05, 95% CI 0.03–0.09, I2 = 62%; see Fig. 3C and 3 D). 3.5.

Sensitivity analyses for meta-analysis

The sensitivity analyses did not reveal a clear reason for the high heterogeneity in the pooled estimate of the outcomes (objective cure, OCR, and explantation) when investigating subgroups for severity of incontinence, sling type, followup, and outcome definition (results not shown). Exclusion of the two cohorts from the only randomized controlled trial (numbers 13a and 13b) [21] did not alter the pooled estimate for the objective cure in fixed or in slings (results not shown). 3.6.

Discussion

This is the first systematic review and meta-analysis that compares the efficacy and safety of the different types of slings for the treatment of PPI reported in 64 studies with 72 patient cohorts. The pooled proportion estimate of objective cure for adjustable slings was 0.61, higher than that for fixed slings

11

(0.50); however, the 95% CI overlap (0.51–0.71 vs 0.45–0.56) was notable. There is high heterogeneity in both groups (I2 = 82%, p < 0.01 in fixed slings and I2 = 88%, p < 0.01 in adjustable slings). Considering the most frequently implanted slings, 77.8% (7/9) in the Argus T group and 45.5% (5/11) in the AdVance group were cured after 18 mo. The adjustable sling provided better results in 24h pad test and subjective cure, although complications were more frequent in this group. However, both slings improved the quality of life [21]. In particular, up to 86.9% (40/46) of patients are socially continent after implantation of an AdVance sling, and 80% (49/61) of patients are even completely dry [9,13]. Moreover, up to 92% (23/25) of patients achieved social continence and 90% (18/20) no longer use pads after implantation of an adjustable sling [12,61]. However, all these high cure rates were measured at short or medium follow-up. Observation of the results showed that the cure rates decrease in the long term. The cure rate of the AdVance sling decreased from 81% (58/72) at 3 mo postoperatively to 51% (37/72) at a median followup of 52 mo [22]. For the I-StopTOMS sling as well, the cure rate decreased at each time point as compared with baseline. The result dropped to 40% at medium follow-up and 15% (3/21) at long-term follow-up [41]. The loss of efficacy of fixed slings with time is well known in clinical practice; more studies with long-term follow-up are needed. The advantage of adjustable slings is that the tension of the sling can be adapted postoperatively. To date, only two selfmade adjustable slings were followed over 40 mo [70,71]. Thus, more studies with long-term follow-up are needed to prove the benefit. The inhomogeneous outcome depends not only on the varying definitions of cure and different follow-ups. Many studies also included patients with severe incontinence, which leads to heterogeneity and may be a reason for poorer outcomes [14,24]. Male slings, especially adjustable ones, are a relatively new treatment option. The learning curve may be an issue for worse results in the first studies; surgeons had to gain experience with the different devices. To date, all slings have been updated (AdVance, Argus) or replaced (InVance). In comparison, the artificial urinary sphincter (AUS) is the device that is associated with the longest experience; social continence was achieved in 61– 100% and dry rate varied from 4% to 86% in long-term follow-up [73]. Thus, the AUS may still be the standard of care for the treatment of severe incontinence. The subjective cure rate in individual studies ranged from 33% (2/6) to 94.4% (34/36) in fixed slings and from 28% (8/29) to 100% (9/9) in adjustable systems. The subjective cure rate is higher than the objective cure rate in all studies where both were reported, which was the case in 34.7% (25/72) of the cohorts. Although the objective cure rate is only moderate in some studies [14,31,44], patients still seemed satisfied with the procedures. Even though the AUS is still the standard of care in the treatment of severe incontinence and its subjective cure rate is up to 80% [74], patients prefer a male sling to AUS as they wish to avoid a mechanical device [75]. Furthermore, sling implantations are associated with a shorter operation

Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

No.

Author

Sling

Pat

OCR

NoC CDK Retention Urgency Infection Erosion Defect

Pain

Revision Explantation

Early postop Chronic

Barnard et al (2014) [9] Bauer et al (2017) [10] Berger et al (2011) [11] Chung et al (2016) [12] Collado Serra et al (2013) [13]

6 7 8 9 10 11 12 13a 14 15 16a 16b 17 18 19a 19b 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36a 36b 37 38 39 40a 40b 41a 41b

Cornel et al (2010) [14] Cornu et al (2011) [15] Grimsby et al (2012) [16] Habashy et al (2016) [17] Kowalik et al (2015) [18] Leruth et al (2012) [19] Li et al (2012) [20] Lima et al (2016) [21] Papachristos et al (2018) [22] Rehder et al (2012) [23] Sturm et al (2014) [24] Sturm et al (2014) [24] Suskind et al (2011) [25] Torrey et al (2013) [26] Wright et al (2017) [27] Wright HC et al (2017) [27] Zuckerman et al (2014) [28] Athanasopoulos et al (2010) [29] Ballert and Nitti (2010) [30] Carmel et al (2010) [31] Castle et al (2005) [32] Comiter (2005) [33] Fischer et al (2007) [34] Gallagher et al (2007) [35] Giberti et al (2009) [36] Guimaraes et al (2009) [37] Styn et al (2011) [38] Yiou et al (2016) [39] Galiano et al (2016) [40] Malval et al (2017) [41] Le Portz et al (2016) [42] Sacco et al (2018) [43] Comiter et al (2014) [44] Comiter et al (2014) [44] Ferro et al (2017) [45] McCall et al (2016) [46] Rajpurkar et al (2005) [47] Samli and Singla (2005) [48] Samli and Singla (2005) [48] Dikranian et al (2004) [49] Dikranian et al (2004) [49]

AdVance AdVance XP AdVance AdVance AdVance/ AdVance XP AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance AdVance XRT AdVance no XRT AdVance InVance InVance InVance InVance InVance InVance InVance InVance InVance InVance TOMS I-Stop TOMS I-Stop TOMS Surgimesh M-Sling TiLOOP Virtue Virtue fixed Virtue Virtue Self-made bone fixed, Self-made bone fixed, Self-made bone fixed, Self-made bone fixed, Self-made bone fixed,

n (%)

n

46 115 26 19 61

– – – 2 (11) –

11 7* 14 2 21

– – – 1 (2) – – 8 (13.6) – – – – – 4 (9.5) – – – – 13 (30.2) – – – – 13 (21) – – – 70 (58.8) – – – 4 (4.4) 14 (31.8) – – 17 (58.6) – – 4 (14.8) 1 (8.3) 2 (12) 2 (10)

2* 38 10 1 16 44* 16 4 24 109 14 7 5 34 1 11 21 13 – 17 4* 11 13 4 37 21 111 – 7 1 4 26 28 10 17 16 3 4 1 2 2

36 136 31 50 30 173 56 11 86 151 72 23 42 37 14 22 102 43 – 45 38 48 62 31 40 62 119 – 34 100 93 44 98 31 29 32 different materials 46 not absorbable 27 absorbable 12 silicone 16 Pelvicol 20

 



 

    



   

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

1 2 9 2 9

– 4 (–) – – 5 (8)

1 (2) – – – –

– – – – –

– – – – –

8 (–) I 5 (19.2) – 5 (8)

1 (–) – – – –

– – – – –

– – – – –

– – – – – – – – – 1 (0.6) – – – – – – – 6 (14) – 2 (–) – – 1 (–) – 2 (5) – 21 (17.6) – – – – – – – – – – 4 (–) 1 (–) – –

1 (–) – – – 1 (–) 3 (1.7) – – 1 (–) 1 (0.6) – – 1 (–) – – – 1 (–) 5 (11.7) – 1 (–) 3 (7.9) 1 (–) 3 (–) 2 (–) 6 (15) 2 (3) 19 (16) – 1 (2.9) – – – – – – – 1 (–) – – – 1 (5)

– – – – – – – – – – – – 1 – – – – – – – 1 1 1 – – – 1 – – – – – – – – – – – – – –

– – – – – – – – – – – – – – – – – – – – – 2 (–) – – – 1 (2) 9 (7.5) – – – – – – – – – – – – – –

36 (100) – (10) 1 (–) – 1 (–) 39 (23)/167 – 2 (–) – 78 (50)+ – – – 5 (–) 1 (–) 4 (–) 5 (–) – – 10 (–) II 7 (16) – – 29 (73) 12 (19) – – – 1 (–) 1 (1.1) 9 (20.5)+ – (14.3) – (12.9) 5 (17.24) – 2 (–) – – – –

– – – – 1 (–) 8(5)/156 3 (–) – – – 2 (–) 1 (–) – – – – 1 (–) – – – – – 5 (–) 1 (–) – – 6 (5) – – – 1 (1.1) – – – – 2 (7) – – – – –

– – 1 (–) 1 (–) – – – – – – – 3 (–) – – – – – – – – – 2 (–) 9 (14.5) – – 1 (2) 19 (16) – – – – – – – – – – – – – –

1 – – – – – – – 1 1 – – 1 – – – 1 2 – 1 – – 3 4 4 2 – – – – – – – – – 7 1 – – – 1

(2) (–) (34.6) (11) (15)

1 (–) – 9 (29) 1 (–) 9 (30) 26 (15) 6 (–) 1 (–) 22 (25) 15 (9.6) 11 (–) 5 (–) 3 (–) 16 (–) – 5 (–) 12 (11.8) 1 (2.3) – 3 (–) – – 2 (–) 1 (–) – 6 (10) 16 (13.5) – 1 (2.9) – 2 (2.2) – – – 3 (10.3) 14 (44) – – – 2 (12) 1 (5)

(–)

(–) (–) (–)

(0.8)

(–)

(–) (0.6)

(–)

(–) (–) (–)

(–) (13) (–) (3)

(22) (–)

(–)

E U R O P E A N U R O L O GY F O C U S X X X ( 2 0 18 ) X X X– X X X

1 2 3 4a 5

N

EUF-659; No. of Pages 18

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Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

Table 3 – Complications.

EUF-659; No. of Pages 18

No.

Author

Sling

Pat

OCR

NoC CDK Retention Urgency Infection Erosion Defect

Pain

Revision Explantation

Early postop Chronic

42 43a 43b 44 45 46 47 48 49 50 4b 51 52 53 54 55 13b 56 57 58 59 60 61 62 63 64

Madjar et al (2001) [50] Self-made bone fixed Crites et al (2011) [51] Bone-fixed sling Crites et al (2011) [51] Transobturatoric sling John and Blick (2008) [52] Self-made Migliari et al (2006) [53] Self-made Schaeffer et al (1998) [54] Self-made Wadie (2010) [55] Self-made Wu et al (2017) [56] Self-made Xu et al (2007) [57] Self-made Bochove-Overgaauw and Schrier (2011) [58] Argus classic Chung et al (2016) [12] Argus classic Dalpiaz et al (2011) [59] Argus classic Hubner et al (2011) [60] Argus classic Miodrag et al (2014) [61] Argus classic Bauer et al (2015) [62] Argus T Cornel (2016) [63] Argus T Lima et al (2016) [21] Argus T Siracusano et al (2017) [64] Argus T Angulo et al (2017) [65] ATOMS Friedl et al (2017) [66] ATOMS Krause et al (2014) [67] ATOMS Kim et al (2016) [68] Remeex Sousa-Escandon et al (2007) [69] Remeex Altan et al (2017) [70] Self-made adjustable Balci et al (2015) [71] Self-made adjustable Inci et al (2008) [72] Self-made adjustable

N

n (%)

n

n (%)

n (%)

n (%)

n (%)

n (%)

16 30 30 57 49 64 40 31 26 100 25 29 101 20 42 36 11 182 34 287 36 64 51 58 21 19

– – – – – – – – – 55 (55) 1 (4) 24 (83) – 1 (5) – – – 26 (14.2)* – – – – – – – –

4 8 9 14 3* 8* 2* 12* 7 74 1 37 34 1 7* 47 10 26* 15 70 32 6 6* 16 10 13

1 (–) – 4 (13.3) 8 (–) – 1 (–) – 6 (–) – 16 (–) 1 (4) 15 (–) – – – 7 (–) 3 (–) 16 (8.8) 4 (11.8) 8 (3) 2 (5.6) – – 4 (–) – 3 (–)

– 1 – – – – – – – 1 – 4 – – 3 – – – – – – – – – – –

– – – – 3 (–) 2 (3) – 6 (–) – 8 (–) – 2 (–) 6 (–) 1 (5) 3 (–) 10 (–) – 9 (4.9) – 12 (–) 7 (19.4) 3 (4.7) 2 (–) 1 (–) 4 (–) 2 (–)

– – – – – 5 (6) –

– 3 (10) – – – – –



 

 

 

(3.3)

(–) (–)

(–)

– 3 (–) – 3 (–) 13 (–) – – – – 1 (0.5) – – 1 (2.8) – 1 (–) – – –

n (%)

3 (–) 3 (10) 4 (13.3) 4 (–) III IV V VI – 4 (15.4) 1 (–) – – – 2 (–) – – 15 (14.9) – – – – – 17 (–)+ – 2 (–) – 72 (38.5) – 2 (5.9) 17 (–) – 3 (8.3) 10/34 (29.4) 1 (1.6) – – VII – 10 (–) – 6 (–) – 8 (–)

n (%)

n (%)

n (%)

– – – – – 5 – – – 5 – 1 – – 7 – 2 – – 1 – 1 – – –

– 3 (10) – – 3 (–) 17 (27) 10 (25) 9 (55.5) – – – 3 (–) – – – 7 (38.9) 3 (–) – – 14 (5) 1 (–) – 2 (–) 1 (–) 3 (–) 1 (–)

– – – – – 7 (–) – 6 (19.4) – 11 (–) – 10 (35) 16 (15.8) 1 (–) 5 (–) 4 (22.3) 1 (–) 17 (9.3) – 56 (20) 11 (30.6) 3 (–) 1 (–) 8 (–) 2 (–) –

(19)

(–) (3)

(–) (–)

(2) (1.6)

CDK = use of the Clavien-Dindo classification; NoC = number of complications; OCR = overall complication rate; Pat = number of patients from whom complications were evaluated; XRT, radiotherapy;  = shown in the study;  = not given. Data that were not given in the study have been calculated afterward and are highlighted in red in the table. Early postoperative pain: resolved within the first 3 mo after sling implantation. Chronic pain: pain lasting longer than 3 mo. Revision: additional procedures on the sling, explantation of parts of the sling (port). Explantation: removal of the whole sling. I: the mean postoperative pain score on the VAS was 0.5 at the 3-mo follow-up, 0.4 at the 6-mo follow-up, 0.3 at the 12-mo follow-up, 0.3 at the 24-yr follow-up, and 0.0 at the 36- mo follow-up. II: immediately following surgery, the majority of patients reported significant perineal pain that resolved completely after 3–4 mo. III: immediately after surgery, 96% of the patients reported significant perineal pain, which resolved completely at a median of 3.7 mo. IV: all patients experience initial perineal discomfort that usually persists for 4–6 wk; five (19%) patients reported discomfort lasting longer than 3 mo. V: after 1 wk, scrotal and perineal pain was notable in all patients. VI: immediately after surgery, all patients reported mild and tolerable wound pain. VII: most patients felt transient pain or perineal discomfort, which was treated with oral medications. * Number of complications without pain. + Early postoperative pain resolved within the first 6 mo after sling implantation.

E U RO P E A N U RO L O GY F O C U S X X X ( 2 018 ) X X X– X X X

13

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Table 3 (Continued )

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E U R O P E A N U R O L O GY F O C U S X X X ( 2 0 18 ) X X X– X X X

Fig. 3 – Meta-analysis for overall complication rate in (A) fixed and (B) adjustable slings, and for explantation in (C) fixed and (D) adjustable slings. CI = confidence interval.

time and no postoperative deactivation period, and are more cost effective. The effect on patients’ quality of life was assessed in 62.5% (45/72) of the cohorts by questionnaires. The International Consultation on Incontinence Questionnaire—Urinary Index—Short Form [76], PGI-I

[77], and International Prostate Symptom Score Quality of Life [78] were the most commonly used questionnaires. Unfortunately, due to the heterogeneity of questionnaires, these cannot be compared; furthermore, these questionnaires are not specific to PPI. In addition, it was not noted

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EUF-659; No. of Pages 18 E U RO P E A N U RO L O GY F O C U S X X X ( 2 018 ) X X X– X X X

whether the patients completed the questionnaire on their own or together with medical staff, which makes a serious difference [79]. Although 97.2% (70/72) of the cohorts reported complications, the OCR was assessed only in 26.4% (19/72) of the cohorts. Thus, we must discuss these data with reservation. The OCR was higher for adjustable slings (0.26, 95% CI 0.08– 0.61) than for fixed slings (0.18, 95% CI 0.10–0.29), but the 95% CI overlap was notable and high heterogeneity was observed (I2 = 95% vs I2 = 88%). The very high OCR in studies 30 and 51 may be because these studies concentrated on the complications after sling implantation [38,59]. It should be noted that pain was not included in the OCR in study 56 [64]. Although 80.6% (58/72) of the patient cohorts reported postoperative pain, we can scarcely compare the data, as the reports are too heterogeneous. It was rarely noted how and when pain was measured, and how many patients were asked about it. The reports vary from “most patients felt transient pain or perineal discomfort” to “the mean postoperative pain score on the visual analog scale was 0.5 at the 3-mo follow-up and 0.0 at the 36-mo follow-up” [10,69]. Urinary retention was the most reported complication in fixed slings after pain. A reason for this might be that the tension of fixed slings cannot be adjusted postoperatively; therefore, the surgeons tighten the slings additionally for more success. In most studies, urinary retention resolved in the early postoperative period. Only four studies reported on revision due to prolonged retention [16,17,24,34]. The most often reported complication in adjustable slings is infection. More material, the silicon device, and the double cut and adjustments might present a risk of infection, and explains (in part) why adjustable slings lead to explantation more often than fixed slings (0.14, 95% CI 0.10–0.18, I2 = 64% vs 0.05, 95% CI 0.03–0.09, I2 = 62%). In comparison, infection or erosion occurred in 8.5% of cases (3.3–27.8%) in AUS; the reoperation rate was 26.0% [73]. A study of the Debates on Male Incontinence (DOMINO)-Project analyzed the intraoperative complications and explantation rate of the AUS and the Argus slings (Argus classic and Argus T) [80]. The explantation rate was significantly higher after AUS implantation. The main reasons for explantation of the adjustable sling were persistent incontinence and system dislocation, but these results do not agree with ours [80]. The main cause of explantation was infection in our included studies. However, in the study of the DOMINO-Project, any kind of postoperative infection (urinary tract infection, epididymitis, or wound infection) was a strong independent predictor for increased device explantation [80]. In the discussion of complications, identification of risk factors is a necessary point to consider. Of the patient cohorts, 62.5% (45/72) reported on risk factors. Those most reported risk factors were previous radiotherapy, severe incontinence, obesity, and previous incontinence surgery. A study of the DOMINO-Project analyzed the impact of risk factors for male slings and AUS [81]. A history of pelvic irradiation was an independent risk factor for explantation in fixed and adjustable slings and AUS. Moreover, previous incontinence surgery was a predictor of impaired wound

15

healing in male slings [81]. Nevertheless, in many of our studies, these factors were not associated with a lower outcome. In addition, patients with risk factors were excluded from many studies. Thus, we cannot definitely confirm the reported risk factors. However, in the study of the DOMINO-Project, age of patients did not affect the outcomes, which is in complete agreement with the results of our studies [81]. The sensitivity analysis did not reveal a clear reason for the high heterogeneity by investigating grouping for severity of incontinence, sling type, follow-up, and outcome definition. Strictly speaking, four patient cohorts (studies 13a, 13b, 19a, and 40b) do not fulfill our inclusion criteria of a minimum of 15 patients, but the sensitivity analysis found no difference. This systematic review and meta-analysis has several limitations to consider. Only one of the included studies is a randomized study, so that only 22 patients have been randomized [21]. Of the included studies, 37.5% have a retrospective study design. The AdVance sling (22/72) was implanted more frequently than all adjustable slings together (17/72). Heterogeneity among included patient cohorts was a major issue. The median follow-up ranges from 12 to 58 mo, and the number of patients varies between 16 and 287. Some studies excluded patients with risk factors such as previous radiotherapy, previous incontinence surgery, or severe incontinence. Nevertheless, the different definitions of continence are one of the largest problems in comparing the outcomes. Nine different definitions of cure were used and overlapped with the definition of success. For evidence-based recommendations, well-designed, prospective, randomized studies with long-term follow-up and the same strict definition for continence are needed. Our method is also not without limitations. First of all, we limited our search to studies in English. Second, we cannot estimate the publication bias. The data were extracted by only one reviewer, but a second reviewer thoroughly monitored the database. In addition, we renounced quality assessment, so the risk of bias of the included studies is unclear. 4.

Conclusions

Both fixed and adjustable slings are beneficial for the treatment of PPI. Adjustable slings might lead to higher objective cure rates, but they might also be associated with higher complication and explantation rates. However, due to significant heterogeneity of the data, this cannot be said with certainty at present. More randomized controlled trials with long-term follow-up and the same definition for continence are needed. Author contributions: Orietta Dalpiaz had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Meisterhofer, Dalpiaz. Acquisition of data: Meisterhofer, Dalpiaz. Analysis and interpretation of data: Herzog, Dalpiaz.

Please cite this article in press as: Meisterhofer K, et al. Male Slings for Postprostatectomy Incontinence: A Systematic Review and Meta-analysis. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.01.008

EUF-659; No. of Pages 18 16

E U R O P E A N U R O L O GY F O C U S X X X ( 2 0 18 ) X X X– X X X

Drafting of the manuscript: Meisterhofer, Dalpiaz.

a prospective clinical trial comparing patient choice, clinical out-

Critical revision of the manuscript for important intellectual content: Bauer,

comes and satisfaction rate with a minimum follow up of

Dalpiaz.

24 months. Neurourol Urodyn 2016;35:482–6.

Statistical analysis: Herzog. Obtaining funding: None.

[13] Collado Serra A, Resel Folkersma L, Dominguez-Escrig JL, GomezFerrer A, Rubio-Briones J, Solsona Narbon E. AdVance/AdVance XP

Administrative, technical, or material support: Sebastianelli, Strini.

transobturator male slings: preoperative degree of incontinence as

Supervision: Dalpiaz.

predictor of surgical outcome. Urology 2013;81:1034–9.

Other: None.

[14] Cornel EB, Elzevier HW, Putter H. Can advance transobturator sling suspension cure male urinary postoperative stress incontinence? J

Financial disclosures: Orietta Dalpiaz certifies that all conflicts of interest, including specific financial interests and relationships and affilia-

Urol 2010;183:1459–63. [15] Cornu JN, Sebe P, Ciofu C, Peyrat L, Cussenot O, Haab F. Mid-term

tions relevant to the subject matter or materials discussed in the manu-

evaluation of the transobturator male sling for post-prostatectomy

script (eg, employment/affiliation, grants or funding, consultancies,

incontinence: focus on prognostic factors. BJU Int 2011;108:236–40.

honoraria, stock ownership or options, expert testimony, royalties, or

[16] Grimsby GM, Tyson MD, Wolter CE. Early outcomes of the trans-

patents filed, received, or pending), are the following: None.

obturator male sling based on body mass index. Can J Urol 2012;19:6088–93.

Funding/Support and role of the sponsor: None.

[17] Habashy D, Losco G, Tse V, Collins R, Chan L. Mid-term outcomes of a male retro-urethral, transobturator synthetic sling for treatment of post-prostatectomy incontinence: impact of radiotherapy and stor-

Appendix A. Supplementary data

age dysfunction. Neurourol Urodyn 2017;36:1147–50. [18] Kowalik CG, DeLong JM, Mourtzinos AP. The advance transobturator male sling for post-prostatectomy incontinence: subjective and

Supplementary data associated with this article can be found, in the online version, at https://doi.org/10.1016/j.euf. 2019.01.008.

objective outcomes with 3 years follow up. Neurourol Urodyn 2015;34:251–4. [19] Leruth J, Waltregny D, de Leval J. The inside-out transobturator male sling for the surgical treatment of stress urinary incontinence after radical prostatectomy: midterm results of a single-center prospec-

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