The Prospective Study of Ajust R and TVT-OTM in the Treatment of SUI

XIN Xing; SONG Yue; XIA Zhi-jun

Abstract：Objective:To compare the patient-reported and objective cure rates, postoperative pain, postoperative complications, and postoperative quality of life of Adjustable Single-incision Sling (Ajust ) versus Tension-free Vaginal Tape-obturator (TVT-OTM) in the treatment of female stress urinary incontinence (SUI). Methods:A randomised trial was conducted in the period between January 2012 and May 2013, with the 327 SUI female patients randomised to either Ajust group (163 cases) or TVT-OTM group (164 cases). Evaluations were performed to compare the patient-reported and objective cure rates, postoperative complications, postoperative pain profile using Visual Analogue Scale (VAS), Patient Global Impression of Improvement Scale (PGI-I) and International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) of these two groups. Results:Compared with the TVT-OTM group, patients in the Ajust group had a significantly lower postoperative pain (P<0.05), shorter operative duration, and less intraoperative blood loss (P=0.00). No significant difference in peri-operative complications was shown between these two groups. Patient-reported and objective cure rates between the Ajust and TVT-OTM groups were:92.0%versus 89.6%and 95.1%versus 93.9%respectively, but this did not reach statistical significance (P>0.05). In comparison with the TVT-OTM group, the Ajust group showed an earlier recovery to normal activities (P=0.00). It is proved in PGI-I that both Ajust and TVT-OTM groups had a significant improvement of life quality (P=0.00), but no significant difference was shown about the average improvement of life quality between these two groups ( P=0.235). Conclusions:Ajust procedure is simple, safe and effective treatment of SUI. Compared with TVT-O TM, Ajust is simpler and faster, less intraoperative blood loss, generates less postoperative pain and quicker recovery.