The comparison of the results of miniinvasive treatment of stress urinary incontinence using Ajust^TM and MiniArc^TM system

Česká verzia

Authors: Jan Krhut ^1,2; Alois Martan ³; Marcel Gärtner ⁴; Roman Zachoval ⁵; Kamil Švabík ³; Michal Halaška ⁶; Lukáš Horčička ⁷; Josef Tvrdík ⁸; Tomáš Hanuš ⁹
Authors place of work: Katedra chirugických oborů LF OU Ostrava ¹; Urologické oddělení FN, Ostrava-Poruba ²; Gynekologicko-porodnická klinika 1. LF UK a VFN, Praha ³; Gynekologicko-porodnická klinika FN Ostrava-Poruba ⁴; Urologické oddělení Fakultní Th omayerova nemocnice, Praha ⁵; Gynekologicko-porodnická klinika FN Bulovka a 1. LF UK, Praha ⁶; GONA spol. s r. o., Praha ⁷; Přírodovědecká fakulta OU, Ostrava ⁸; Urologická klinika 1. LF UK a VFN, Praha ⁹
Published in the journal: Ces Urol 2012; 16(1): 20-28
Category: Original article

Summary

Aim:
The aim of the study was to compare the effectiveness of two minimally invasive surgical techniques for stress urinary incontinence in female patients (Ajust^TMand MiniArc^TM), using subjective assessment as well as evaluation of objective parameters.

Methods:
A total of sixty-six female patients with stress urinary incontinence were enrolled into the prospective, randomized, multicentre trial, mean age 57.8 years (range 42–88 years). Patients in Group A had undergone surgery using Ajust^TMmethod; patients in Group B underwent surgery using the MiniArc^TMmethod.

The subjective satisfaction of the patients along with the outcome of the procedure was evaluated using a standardized questionnaire “The International Consultation on Incontinence (ICI-Q)”. The objective assessment was performed with the use of cough test, urodynamics (bladder volume at the first desire to void – FDV, cytometric capacity – CC, maximum urethral closure pressure – MUCP, maximum urinary flow – Qmax), and ultrasound parameters (difference between the gamma –gamma_difangles, distance between vesicourethral junction at rest and during the Valsalva maneuver – d). All of the parameters were measured prior to treatment, and three months following the surgical procedure. Statistical evaluation was performed with the two-choice t-testand nonparametric two-choice Wilcoxon’s test, with the correction for sequence alignment.

Results:
When assessing the subjective satisfaction ofthe procedure, we found, that both groups of patients reported a significant improvement in the total score (-14.09 ± 5.18 vs. -14.45 ±3.73), no significant difference was observed between the two methods (p = 0.74569). Objective assessment of the surgical procedure documented a lack of incontinence in a total of 61 patients (92.43%) following surgery. These included 31 patients (94%) from Group A and 30 patients from Group B (91%).

When we compared the urodynamic parameters before and after the surgery, we observed a significant increase of the cytometric capacity in patients of Group B. No other statistically significant differences between these two surgical procedures were observed in the other parameters.

A clear decrease in the uretrovesical junction mobility was observed in comparison with the pre-surgery measurements using introital sonography. We observed a decrease in the gamma angle (-13.82 ± 21.63 vs. -9.82 ± 17.17), as well as a shortening of the d line segment (-3.75 ± 6.93 vs. -3.53 ± 5.53). No statistically significant differences were observed between both methods of surgical treatment.

Conclusion:
Our initial experience with the surgical techniques Ajust^TMand MiniArc^TM, with respect to the effectiveness and possible per- or postoperative complications, are good. From our assessment carried out at three-month follow up after the surgery it is apparent that the effectiveness of both surgical procedures are comparable. However, further follow-up is necessary for a definitive assessment of both methods.

Key words:
stress urinary incontinence, surgical treatment, minisling, Ajust^TM, MiniArc^TM.

Zdroje

1. Abrams P, Cardozo L, Fall M, et al. Th e standardization of Terminology of Lower Urinary Tract Function: report from the Standardization Subcommittee of the International Continence Society. Neurourol Urodyn 2002; 1: 167–178.

2. Burch JC. Urethrovaginal fi xation to Cooper’s ligament for correction of stress incontinence, cystocele and prolapse. Am J Obstet Gynecol 1961; 81: 281–290.

3. Lapitan MC, Cody JD, Grant A. Open retropubic colposuspension for urinary incontinence in women. Cochrane Database Syst Rev 2009; 7(4): CD002912.

4. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol 1995; 29: 75–82.

5. Sung VW, Schleinitz MD, Rardin CR, et al. Comparison of retropubic versus transobturatoor approach to midurethral slings: a systematic review and meta-analysis. Am J Obstet Gynecol 2007; 197(1): 3–11.

6. Delorme E. Transobturator urethral suspension: miniinvasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001; 11: 1306–1313.

7. Meshia M, Barbacini P, Barbacini R, et al. Short-term outcomes with the Ajust^TM system: a new single incision sling for the treatment of stress urinary incontinence. Int Urogynecol J 2011; 22(2): 177–182.

8. Ridder D, Berkers J, Deprest J, et al. Single incision mini-sling versus a transobturator sling: a comparative study on MiniArc^TM and Monarc^TM slings. Int Urogynecol J 2010; 21(7): 773–778.

9. Schäfer W, Abrams P, Liao L, et al. Good urodynamic practices: urofl owmetry, fi lling cystometry, and pressure-fl ow studies. Neurourol Urodyn 2002; 21: 261–274.

10. Richter HE, Albo ME, Zyczynski HM. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 2010; 362: 2066–2076.

11. Daneshgari F, Kong W, Schwartz M. Complications of of midurethral slings: important outcomes for future clinical trials. J Urol 2008; 180(5): 1890–1897.

12. Oliveira R, Botelho F, Silva P, et al. Exploratory study assessing affi cacy and complications of TVT-O, TVT-Secur, and MiniArc: results at 12 month follow-up. Eur Urol 2011; 59(6): 940–949.

13. Martan A, Svabik K, Masata J, et al. Initial experience with short, tension-free vaginal tape (the tension-free vaginal tape secur systém). Eur J Obstet Gynecol Reprod Biol 2009; 143: 121–125.

14. Abdel-Fattah M, Agur W, Abdel-Al M, et al. Prospective multi-centre study of adjustable single-incision mini-sling (Ajust) in the management of stress urinary incontinence in women: 1 year follow-up study. BJU Int 2011; doi: 10.1111/j.1464-410X.2011.10471.x. (Epub ahead of print).

15. Kennelly MJ, Moore R, Nguyen JN, et al. Prospective evaluation of a single incision sling for stress urinary incontinence. J Urol 2010; 184(2): 604–609.

16. Calvo JJ, Alfaro AH, Lostal JLC, et al. Stress urinary incontinence surgery with MiniArc sling systém: our experience. Actas Urol Esp 2010; 34(4): 372–377.

17. Ridgeway BM, Arias B, Barber MD, et al. Variation of the obturator foramen and pubic arch of the female bony pelvis. Am J Obstet Gynecol, 2008; 198: 546.e1–546.e4.

18. Martan A, Svabik K, Masata J, et al. Correlation between changes in ultrasound measurements and clinical curative eff ect of tension-free vaginal tape-SECUR procedure. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20: 533–539.