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-OTM, Ajust■ is simpler and faster, less intraoperative blood loss, generates less postoperative pain and quicker recovery.

Key words: Urinary incontinence, stress, Pain, postoperative, Postoperative complications, Prospective studies