Evaluation of initial experience with safety and short efficacy of mini-sling antiincontinence procedures MiniArc and AJUST system
Authors:
A. Martan 1
; K. Švabík 1; M. Halaška 2; R. Zachoval 3; L. Horčička 4; J. Krhut 5
Authors‘ workplace:
Gynekologicko-porodnická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr. A. Martan, DrSc.
1; Gynekologicko-porodnická klinika FN Bulovka a 1. LF UK, Praha, přednosta prof. MUDr. M. Halaška, DrSc.
2; Urologické oddělení, Fakultní Thomayerova nemocnice, Praha, přednosta doc. MUDr. R. Zachoval, CSc.
3; GONA spol. s r. o., Praha, vedoucí MUDr. L. Horčička
4; Urologické oddělení FN, Ostrava-Poruba, přednosta doc. MUDr. J. Krhut, CSc.
5
Published in:
Ceska Gynekol 2011; 76(5): 349-355
Overview
Objective:
The aim of our study is to present initial experiences, with regard to safety and short-term efficacy, of mini-sling MiniArc and AJUST operations for stress urinary incontinence (SUI).
Design:
Cross-sectional clinical study.
Settings:
Gynecological and Obstetric Clinic 1. LF UK and VFN Prague; Gynecological and Obstetric Clinic FN Bulovka and 1. LF UK Praha; Urological dpt. FTN Prague; GONA spol. s r.o.; Urological dpt. FN Ostrava Poruba.
Materials and methods:
We present briefly the technique employed in the operations, the urodynamic examination procedure before and after the operation, and the subjective and objective outcomes of these procedures from the 5 above-mentioned hospitals which participated on the study. Objectively the leakage of urine was assessed during urodynamic examination and by cough test. Subjectively leakage of urine was assessed by ICIQ-SF questionnaire (The International Consultation on Incontinence, short form). This study evaluated the cure effect and complications accompanying the MiniArc and AJUST procedures, and compared these results. The clinical study included 66 women with previously untreated stress urinary incontinence. These women were randomly divided by envelop method into two groups; the first group of patients underwent operations using the MiniArc (n=33) technique and the second group the AJUST (n=33) technique.
Mean age was 57.
9 years in the AJUST group and 57.7 years in the MiniArc group. Mean body mass index (BMI) was 29.2/28.7 in the AJUST/MiniArc groups respectively, and mean parity was 2.09/2.24. We did not find statistically significant differences between these two groups.
Results:
The curative rate of the MiniArc and AJUST procedure was evaluated 3 months after the operation (±1 week). We can conclude from the outcomes of the cough test that this test was negative in 61 (92%) of patients overall; in the AJUST group it was 31 (94%) of patients and in the MiniArc group 30 (91%) of patients. In the subjective evaluation of the leakage of urine before operation (ICIQ-SF) the mean score in the group of patients who subsequently underwent the AJUST operation was 15.4 (SD-3.39; median-16, range 8-21) and in women who underwent the MiniArc operation it was 15.5 (SD-3.3; median-16, range 8-21). The AJUST /MiniArc procedure caused a statistical significant decrease in the total score to -14.09(SD-5.18)/-14.45 (SD-3.73). The difference in the decrease of the score between the AJUST / MiniArc groups was not statistically significant. In the AJUST group of patients, according to the ICIQ-SF, 30 (91%) women were without problem or improved [27 (81.7%) of women were without problem], while in the MiniArc group 32 (96.9%) were without problem or improved [24 (72.7%) of women were without problem]. The urodynamic examination before and after operation indicated that there were no differences between the groups of patients either before and or after the operation. Changes in the parameters MUCP, Qmax and others caused by the operation were not significant, and there were no statistical significant differences in the values of these parameters between the groups of patients. Complications of the MiniArc and AJUST procedures were not recorded.
Conclusions:
Our first experiences with MiniArc and AJUST procedures, including possible complications and curative rate, are positive. From the preliminary results the cure effect of MiniArc and AJUST 3 months after the operation (±1 week) is similar. It will be important to evaluate the efficacy of these procedures one year after the operation for a definitive evaluation of the cure effect.
Key words:
female urinary incontinence, complications, MiniArc, AJUST.
Sources
1. Abrams, P., Blaivas, JG., Stanton, DL., Anderson, JT. The standardization of terminology of lower urinary tract function recommended by the International Continence Society. Int Urogynecol J, 1990, 1, p. 45-48.
2. Abrams, P., Cardoso, L., Fall, M., et al. The standardization of Terminology of Lower Urinary Tract Function: report from the Standardization Subcommittee of the International Continence Society. Neurourol Urodyn, 2002, 1, p. 167-178.
3. Bogusiewicz, M., Bogusiewicz, KR., Drop, A., et al. Anatomical variation of bony pelvis from the viewpoint of transobturator sling placement for stress urinary incontinence. Int Urogynecol J, 2011, 22, p. 1005-1009.
4. Debodiance, P., Delporte, P. MiniArc: preliminary prospective study on 72 cases. J Gynecol Obstet Biol Reprod, 2009, 38(2), p. 144-148.
5. DeLeval, J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol, 2003, 44, p. 724-730.
6. Delorme, E. Transobturator urethral suspension: miniinvasive procedure in the treatment of stress urinary incontinence in women. Prog Urol, 2001, 11, p. 1306-1313.
7. Deole, N., Kaufmann, A., Arunkalaivanan, A. Evaluation of safety and efficacy of single-incision mis-urethral short tape procedure (MiniArcTM tape) for stress urinary incontinence under local anaesthesia. Int Urogynecol J, 2011, 22, p. 335-339.
8. Gauruder-Burmester, A., Popken, G. The MiniArc sling system in the treatment of female stress urinary incontinence. Int Braz J Urol, 2009, 35(3), p. 334-341.
9. Kuuva, N., Nilsson, CG. A national analysis of complications associated with the tension – free vaginal tape procedure. Acta Obstet Gynecol Scand, 2002, 81, p. 72-77.
10. Lord, H., Taylor, J., Finn, J., et al. A randomized controlled equivalence trial of short-term complications and efficacy of tension-free vaginal tape and suprapubic urethral support sling for treating stress incontinence. Brit J Urol, 2006, 98, p. 367-376.
11. Martan, A., Mašata, J., Švabík, K., et al. Initial experience with a short, tension-free vaginal tape (The Tension-free Vaginal Tape Secur System). Eur J Obstet Gynec Reprod Biol, 2009, 143, 2, p. 121-125.
12. Martan, A., Švabík, K., Mašata, J., et al. Correlation between changes in ultrasound measurements and clinical curative effect of tension-free vaginal tape-SECUR* procedure. Int Urogynecol J, 2009, 20, p. 533-539.
13. Meshia, M., Barbacini, P., Barbacini, R., et al. Short-term ourcomes with the AJUSTTM system: a new single incision sling for the treatment of stress urinary incontinence. Int Urogynecol J, 2011, 22, p. 177-182.
14. Nilsson, CG, Falconer, C., Rezapour, M. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J, 2008, 19, p. 1043-1047.
15. Ridder, D., Berkers, J., Deprest, J., et al. Single incision mini-sling versus a transobturator sling: a comparative study on MiniArcTM and MonarcTM slings. Int Urogynecol J, 2010, 21, p. 773-778.
16. Ridgeway, BM, Arias, B., Barber, MD., et al. Variation of the obturator foramen and pubic arch of the female bony Elvis. Am J Obstet Gynecol, 2008, 198, p. 546.e1-546.e4.
17. Ulmsten, U., Petros, P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol, 1995, 29, p. 75-82.
18. Waltregny, D., Gaspar, Y., Reul, O., et al. TVT-O for the treatment of female stress urinary incontinence: Results of a prospective study after a 3-year minimum follow-up. Eur Urol, 2008, 53, p. 401-410.
19. Wang, Y., Li, F., Wang, Q. Comparison of three mid-urethral tension-free tapes (TVT,TVT-O, and TVT-Secur) in the treatment of female stress urinary incontinence: 1-year follow-up. Int Urogynecol J, DOI 10.1007/s00192-011-1445-9, on line.
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Paediatric gynaecology Gynaecology and obstetrics Reproduction medicineArticle was published in
Czech Gynaecology
2011 Issue 5
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