[Evaluation of initial experience with safety and short efficacy of mini-sling antiincontinence procedures MiniArc and AJUST system]

Abstract

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.