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Systematic review and meta-analysis comparing Adjustable Transobturator Male System (ATOMS) and Adjustable Continence Therapy (ProACT) for male stress incontinence


Autoři: Javier C. Angulo aff001;  Sandra Schönburg aff003;  Alessandro Giammò aff004;  Francisco J. Abellán aff001;  Ignacio Arance aff001;  David Lora aff005
Působiště autorů: Departamento Clínico, Universidad Europea de Madrid, Madrid aff001;  Servicio de Urología, Hospital Universitario de Getafe, Madrid, Spain aff002;  Department of Urology and Kidney Transplantation, Martin Luther University, Halle (Saale), Germany aff003;  Department of Neuro-Urology, CTO-Spinal Unit, Città della Salute e della Scienza di Torino, Turin, Italy aff004;  Instituto de Investigación Sanitaria Hospital "12 de Octubre" (i+12), Madrid, Spain aff005;  CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain aff006;  Universidad Complutense de Madrid, Madrid, Spain aff007
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0225762

Souhrn

Background and purpose

Urinary incontinence is one of the most serious complications of prostate cancer treatment. The objective of this study was to assess efficacy and safety of Adjustable Transobturator Male System (ATOMS) compared to Adjustable Continence Therapy (proACT) for male stress urinary incotinence according to literature findings.

Material and methods

A systematic review and meta-analysis on adjustable devices ATOMS and ProACT is presented. Studies on female or neurogenic incontinence were excluded. Differences between ATOMS and proACT in primary objective: dryness status (no-pad or one safety pad/day) after initial device adjustment, and in secondary objectives: improvement, satisfaction, complications and device durability, were estimated using random-effect model. Statistical heterogeneity among studies included in the meta-analysis was assessed using tau2, Higgins´s I2 statistics and Cochran´s Q test.

Results

Combined data of 41 observational studies with 3059 patients showed higher dryness (68 vs. 55%; p = .01) and improvement (91 vs. 80%; p = .007) rate for ATOMS than ProACT. Mean pad-count (-4 vs. -2.5 pads/day; p = .005) and pad-test decrease (-425.7 vs. -211.4 cc; p < .0001) were also significantly lower. Satisfaction was higher for ATOMS (87 vs. 56%; p = .002) and explant rate was higher for proACT (5 vs. 24%; p < .0001). Complication rate for ProACT was also higher, but not statistically significant (17 vs. 26%; p = .07). Mean follow-up was 25.7 months, lower for ATOMS than ProACT (20.8 vs. 30.6 months; p = .02). The rate of working devices favoured ATOMS at 1-year (92 vs. 76; p < .0001), 2-years (85 vs. 61%; p = .0008) and 3-years (81 vs. 58%; p = .0001). Significant heterogeneity was evidenced, due to variable incontinence severity baseline, difficulties for a common reporting of complications, different number of adjustments and time of follow-up and absence of randomized studies.

Conclusions

Despite the limitations that studies available are exclusively descriptive and the follow-up is limited, literature findings confirm ATOMS is more efficacious, with higher patient satisfaction and better durability than ProACT to treat male stress incontinence.

Klíčová slova:

Cancer treatment – Incontinence – Medical devices and equipment – Patients – Publication ethics – Surgical and invasive medical procedures – Systematic reviews


Zdroje

1. Marzorati C, Monzani D, Mazzocco K, Pavan F, Cozzi G, De Cobelli O, et al. Predicting trajectories of recovery in prostate cancer patients undergone Robot-Assisted Radical Prostatectomy (RARP). PLoS One. 2019 Apr 4;14(4):e0214682. doi: 10.1371/journal.pone.0214682 30946773

2. Schaake W, van der Schaaf A, van Dijk LV, van den Bergh ACM, Langendijk JA. Development of a prediction model for late urinary incontinence, hematuria, pain and voiding frequency among irradiated prostate cancer patients. PLoS One. 2018 Jul 17;13(7):e0197757. doi: 10.1371/journal.pone.0197757 30016325

3. Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN. Young Academic Urologists Functional Urology Group. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence. Eur Urol. 2013;63:681–9. doi: 10.1016/j.eururo.2012.11.034 23219375

4. Crivellaro S, Morlacco A, Bodo G, Agrò EF, Gozzi C, Pistolesi D, et al. Systematic review of surgical treatment of post radical prostatectomy stress urinary incontinence. Neurourol Urodyn. 2016;35:875–881. doi: 10.1002/nau.22873 26397171

5. Chen YC, Lin PH, Jou YY, Lin VC. Surgical treatment for urinary incontinence after prostatectomy: A meta-analysis and systematic review. PLoS One. 2017 May 3;12(5):e0130867. doi: 10.1371/journal.pone.0130867 28467435

6. Kretschmer A, bner W, Sandhu JS, Bauer RM. Evaluation and management of postprostatectomy incontinence: A systematic review of current literature. Eur Urol Focus. 2016;2: 245–59. doi: 10.1016/j.euf.2016.01.002 28723370

7. Meisterhofer K, Herzog S, Strini KA, Sebastianelli L, Bauer R, Dalpiaz O. Male slings for postprostatectomy incontinence: A systematic review and meta-analysis. Eur Urol Focus. 2019 Feb 1. pii: S2405-4569(19)30008-2. [Epub ahead of print]

8. Bauer W, Brössner C. Adjustable transobturator male system (ATOMS) for the treatment of post-prostatectomy urinary incontinence: the surgical technique. Pelviperineology 2011; 30: 10–8.

9. Comiter CV, Dobberfuhl AD. The artificial urinary sphincter and male sling for postprostatectomy incontinence: Which patient should get which procedure? Investig Clin Urol. 2016;57:3–13 doi: 10.4111/icu.2016.57.1.3 26966721

10. Hübner WA. ProACT for the treatment of male SUI. In Post-prostatectomy incontinence. Evaluation and management. Singla Ajay & Comiter Craig, Editors. pp 117–123. Springer International Publishing AG 2017

11. R Core Team. R:A language and envionment for statistical computing. R Foundation for Statistical Computing.Vienna, Austria; 2016. Available from https://www.R-project.org/.

12. Hübner WA, Schlarp OM. Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy. BJU Int. 2005;96:587–94. doi: 10.1111/j.1464-410X.2005.05689.x 16104915

13. Trigo-Rocha F, Gomes CM, Pompeo AC, Lucon AM, Arap S. Prospective study evaluating efficacy and safety of Adjustable Continence Therapy (ProACT) for post radical prostatectomy urinary incontinence. Urology. 2006;67(5):965–9. doi: 10.1016/j.urology.2005.11.011 16698356

14. Kocjancic E, Crivellaro S, Ranzoni S, Bonvini D, Gontero P, Frea B. Adjustable Continence Therapy for the treatment of male stress urinary incontinence: a single-centre study. Scand J Urol Nephrol. 2007;41:324–8. doi: 10.1080/00365590601153488 17763225

15. Lebret T, Cour F, Benchetrit J, Grise P, Bernstein J, Delaporte V, et al. Treatment of postprostatectomy stress urinary incontinence using a minimally invasive adjustable continence balloon device, ProACT: results of a preliminary, multicenter, pilot study. Urology. 2008;71:256–60. doi: 10.1016/j.urology.2007.08.062 18308096

16. Gilling PJ, Bell DF, Wilson LC, Westenberg AM, Reuther R, Fraundorfer MR. An adjustable continence therapy device for treating incontinence after prostatectomy: a minimum 2-year follow-up. BJU Int. 2008;102:1426–30. doi: 10.1111/j.1464-410X.2008.07816.x 18564132

17. Crivellaro S, Singla A, Aggarwal N, Frea B, Kocjancic E. Adjustable continence therapy (ProACT) and bone anchored male sling: Comparison of two new treatments of post prostatectomy incontinence. Int J Urol. 2008;15:910–4. doi: 10.1111/j.1442-2042.2008.02161.x 18761534

18. Martens FM, Lampe MI, Heesakkers JP. ProACT for stress urinary incontinence after radical prostatectomy. Urol Int. 2009;82:394–8. doi: 10.1159/000218526 19506404

19. Gregori A, Romanò AL, Scieri F, Pietrantuono F, Incarbone GP, Salvaggio A, et al. Transrectal ultrasound-guided implantation of Adjustable Continence Therapy (ProACT): surgical technique and clinical results after a mean follow-up of 2 years. Eur Urol. 2010;57:430–6. doi: 10.1016/j.eururo.2009.11.031 19942340

20. García Matres MJ, Cansino Alcaide JR, Monasterio S, Rodríguez de Bethencourt F, Hidalgo Togores L, de la Peña Barthel J. Paraurethral adjustable continence therapy device (Pro-ACT) in the treatment of urinary incontinence after prostatic surgery. Arch Esp Urol. 2009;62:871–81. doi: 10.4321/s0004-06142009001000012 20068264

21. Giammò A, Bodo G, Castellano S, Borrè A, Carone R. Spiral multidetector computerized tomography evaluation of adjustable continence therapy implants. J Urol. 2010;183:1921–6. doi: 10.1016/j.juro.2010.01.019 20303116

22. Rouprêt M, Misraï V, Gosseine PN, Bart S, Cour F, Chartier-Kastler E. Management of stress urinary incontinence following prostate surgery with minimally invasive adjustable continence balloon implants: functional results from a single center prospective study. J Urol. 2011;186:198–203. doi: 10.1016/j.juro.2011.03.016 21575974

23. Kjær L, Fode M, Nørgaard N, Sønksen J, Nordling J. Adjustable continence balloons: clinical results of a new minimally invasive treatment for male urinary incontinence. Scand J Urol Nephrol. 2012;46:196–200. doi: 10.3109/00365599.2012.660986 22364390

24. Crivellaro S, Tosco L, Palazzetti A, Abbinante M, Martinez G, Kocjancic E, et al. Geometrical stepper-guided navigation system for ProACT implant under transrectal ultrasound control: preliminary data. Urol Int. 2012;89:473–9. doi: 10.1159/000341991 22965196

25. Gatti L, Moroni A, Cristinelli L, Benedusi F, Antonelli A, Zani D, et al. ProACT (Adjustable Continence Therapy) implants in case of failure of other techniques for urinary incontinence. Urologia. 2012;79 Suppl 19:46–9.

26. Utomo E, Groen J, Vroom IH, van Mastrigt R, Blok BF. Urodynamic effects of volume-adjustable balloons for treatment of postprostatectomy urinary incontinence. Urology. 2013;81:1308–14. doi: 10.1016/j.urology.2013.01.020 23465144

27. Venturino L, Dalpiaz O, Pummer K, Primus G. Adjustable continence balloons in men: Adjustments do not translate into long-term continence. Urology. 2015;85:1448–52. doi: 10.1016/j.urology.2015.01.045 26099887

28. Baron MG, Delcourt C, Nouhaud FX, Gillibert A, Pfister C, Grise P, et al. Sequential treatment with ProACTTM device implantation after male sling failure for male urinary incontinence. Progrès en urologie 2017;27:1098–1103. doi: 10.1016/j.purol.2017.08.001 28847446

29. Nash S, Aboseif S, Gilling P, Gretzer M, Samowitz H, Rose M, et al. Treatment with an adjustable long-term implant for post-prostatectomy stress incontinence: The ProACT™ pivotal trial. Neurourol Urodyn. 2018;37:2854–2859. doi: 10.1002/nau.23802 30178536

30. Nestler S, Thomas C, Neisius A, Rubenwolf P, Roos F, Hampel C, et al. Long-term results of ProACT primary and repeat implantation for treatment of stress urinary incontinence in men. World J Urol. 2019;37:1173–1179. doi: 10.1007/s00345-018-2483-4 30225800

31. Noordhoff TC, Scheepe JR, Blok BFM. Outcome and complications of adjustable continence therapy (proACTTM) after radical prostatectomy: 10 years’ experience in 143 patients. Neurourol Urodyn. 2018;37:1419–1425. doi: 10.1002/nau.23463 29266406

32. Finazzi Agrò E, Gregori A, Bianchi D, Carone R, Giammò A, Ammirati E, et al. Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long-term follow-up data of a national multicentric retrospective study. Neurourol Urodyn. 2019;38:1979–1984. doi: 10.1002/nau.24103 31302928

33. Hoda MR, Primus G, Schumann A, Fischereder K, von Heyden B, Schmid N, et al. Treatment of stress urinary incontinence after radical prostatectomy: adjustable transobturator male system—results of a multicenter prospective observational study. Urologe A. 2012;51:1576–83. doi: 10.1007/s00120-012-2950-2 22836942

34. Seweryn J, Bauer W, Ponholzer A, Schramek P. Initial experience and results with a new adjustable transobturator male system for the treatment of stress urinary incontinence. J Urol. 2012;187:956–61. doi: 10.1016/j.juro.2011.10.138 22264469

35. Hoda MR, Primus G, Fischereder K, Von Heyden B, Mohammed N, Schmid N, et al. Early results of a European multicentre experience with a new self-anchoring adjustable transobturator system for treatment of stress urinary incontinence in men. BJU Int. 2013;111:296–303. doi: 10.1111/j.1464-410X.2012.11482.x 23186285

36. Krause J, Tietze S, Behrendt W, Nast J, Hamza A. Reconstructive surgery for male stress urinary incontinence: Experiences using the ATOMS(®) system at a single center. GMS Interdiscip Plast Reconstr Surg DGPW. 2014 Dec 17;3:Doc15. doi: 10.3205/iprs000056 eCollection 2014. 26504726

37. González SP, Cansino JR, Portilla MA, Rodriguez SC, Hidalgo L, De la Peña J. First experience with the ATOMS(®) implant, a new treatment option for male urinary incontinence. Cent European J Urol. 2014;67:387–91. doi: 10.5173/ceju.2014.04.art14 25667760

38. Friedl A, Bauer W, Rom M, Kivaranovic D, Lüftenegger W, Brössner C. Sexuality and erectile function after implantation of an Adjustable Transobturator Male System (ATOMS) for urinary stress incontinence. A multi-institutional prospective study. Arch Ital Urol Androl. 2016;87:306–11. doi: 10.4081/aiua.2015.4.306 26766803

39. Mühlstädt S, Friedl A, Mohammed N, Schumann A, Weigand K, Kawan F, et al. Five-year experience with the adjustable transobturator male system for the treatment of male stress urinary incontinence: a single-center evaluation. World J Urol. 2017;35:145–151. doi: 10.1007/s00345-016-1839-x 27156092

40. Friedl A, Mühlstädt S, Rom M, Kivaranovic D, Mohammed N, Fornara P, et al. Risk factors for treatment failure with the adjustable transobturator male system incontinence device: Who will succeed, Who will fail? Results of a multicenter study. Urology. 2016;90:189–94. doi: 10.1016/j.urology.2015.12.044 26773347

41. Hüsch T, Kretschmer A, Thomsen F, Kronlachner D, Kurosch M, Obaje A, et al. Debates on Male Incontinence (DOMINO)-Project. Risk factors for failure of male slings and artificial urinary sphincters: Results from a large middle European cohort study. Urol Int. 2017;99:14–21. doi: 10.1159/000449232 27598774

42. Buresova E, Vidlar A, Grepl M, Student V Jr, Student V. Single-centre experience in using the adjustable transobturator male system in treatment of stress urinary incontinence in patients after radical prostatectomy. Journal of Clinical Urology 1–7. doi: 10.1177/2051415817701054

43. Friedl A, Mühlstädt S, Zachoval R, Giammò A, Kivaranovic D, Rom M, et al. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study. BJU Int. 2017;119:785–792. doi: 10.1111/bju.13684 27868328

44. Friedl A, Schneeweiss J, Stangl K, Mühlstädt S, Zachoval R, Hruby S, et al. The adjustable transobturator male system in stress urinary incontinence after transurethral resection of the prostate. Urology. 2017;109:184–189. doi: 10.1016/j.urology.2017.07.004 28712889

45. Angulo J, Arance I, Esquinas C, Dorado J, Marcelino J, Martins F. Outcome measures of adjustable transobturator male system with pre-attached scrotal port for male stress urinary incontinence after radical prostatectomy. Adv Ther. 2017;34: 1173–83. doi: 10.1007/s12325-017-0528-5 28405960

46. Manso M, Alexandre B, Antunes-Lopes T, Martins-da-Silva C, Cruz F. Is the adjustable transobturator system ATOMS® useful for the treatment of male urinary incontinence in low to medium volume urological centers? Actas Urol Esp. 2018;42:267–272 doi: 10.1016/j.acuro.2017.07.011 29174630

47. Angulo JC, Cruz F, Esquinas C, Arance I, Manso M, Rodríguez A, et al. Treatment of male stress urinary incontinence with the adjustable transobturator male system: Outcomes of a multi-center Iberian study. Neurourol Urodyn. 2018;37:1458–1466. doi: 10.1002/nau.23474 29315765

48. Esquinas C, Arance I, Pamplona J, Moraga A, Dorado JF, Angulo JC. Treatment of stress urinary incontinence after prostatectomy with the adjustable transobturator male system (ATOMS®) with preattached scrotal port. Actas Urol Esp 2018;42:473–82. doi: 10.1016/j.acuro.2018.02.005 29642999

49. Angulo JC, Fonseca J, Esquinas C, Ojea A, Rodríguez A, Rabassa M, et al. Adjustable transobturator male system (ATOMS®) as treatment of stress urinary incontinence secondary to transurethral resection of the prostate. Actas Urol Esp. 2018;42:567–573. doi: 10.1016/j.acuro.2018.05.002 29929737

50. Angulo JC, Esquinas C, Arance I, Rodríguez A, Pereira J, Rabassa M, et al. Adjustable transobturator male system after failed surgical devices for male stress urinary incontinence: A feasibility study. Urol Int. 2018;101:106–113 doi: 10.1159/000489316 29953998

51. Giammò A, Ammirati E, Tullio A, Bodo G, Manassero A, Gontero P, et al. Implant of ATOMS® system for the treatment of postoperative male stress urinary incontinence: results of a single centre. Int Braz J Urol.2019;45:127–136. doi: 10.1590/S1677-5538.IBJU.2018.0171 30521175

52. Doiron RC, Saavedra A, Haines T, Nadeau G, Tu LM, Morisset J, et al. Canadian Experience with the Adjustable Transobturator Male System for Post-Prostatectomy Incontinence: A Multicenter Study. J Urol. 2019 Jun 28:101097JU0000000000000420.

53. Esquinas C, Angulo JC. Effectiveness of adjustable transobturator male system (ATOMS) to treat male stress incontinence: A systematic review and meta-analysis. Adv Ther. 2019;36:426–441. doi: 10.1007/s12325-018-0852-4 30560525

54. Larson T, Jhaveri H, Yeung LL. Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta-analysis. Neurourol Urodyn. 2019 Aug 20. doi: 10.1002/nau.24135 [Epub ahead of print] 31429982

55. Angulo JC, Arance I, Ojea A, Carballo M, Rodríguez A, Pereira J, et al. Patient satisfaction with adjustable transobturator male system in the Iberian multicenter study. World J Urol. 2019 Jan 16. doi: 10.1007/s00345-019-02639-4 [Epub ahead of print] 30649591

56. Nash S, Aboseif S, Gilling P, Gretzer M, Samowitz H, Rose M, et al. Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™. Neurourol Urodyn. 2019;38:248–253. doi: 10.1002/nau.23838 30311667


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