The clinical efficacy of needleless sling technique and TOT in the treatment of female stress urinary incontinence: a prospective randomized controlled trial

Objective: To evaluate the efficacy and safety of the single-incision Needleless sling technique in the treatment of female stress urinary incontinence. Methods: From Sept. 2014 to Sept. 2015, 164 consecutive subjects were enrolled in the study and were randomized by envelope technique at the time of surgery to either a transobturator vaginal tape (TOT) or Needleless anti-incontinence procedure. Parameters in perioperative period such as operating time, intraoperative hemorrhage volume, length of stay in hospital, intraoperative complications, and postoperative pain of each patient were recorded. In the follow-up visits, the parameters of operation cure rate, stress urinary incontinence score and groin pain/femoribus internus pain were also recorded and the incontinence questionnaire-short form (ICIQ-SF) was completed. Results: A total of 164 patients assessed for eligibility were randomized into Needleless groups (n=78) and TOT (n=86). There were no significant differences in age, body mass index, process, parity, pad test or the assessment of preoperative quality of life between the two groups. In the perioperative period, statistically significant differences between the two groups were found in operating time, intraoperative hemorrhage volume, groin pain scores at 24 h after operation and length of stay in hospital (P<0.001). After two weeks of follow-up, a statistically significant difference between the two groups was found in groin pain/femoribus internus pain scores, but there were no significant differences in cure rates, pad test, complications or ICIQ-SF. After 1 year, there were no significant differences between the Needleless and TOT groups in cure rates, pad test, groin pain or ICIQ-SF (P>0.05). Both groups registered a significant improvement in the quality of life (P<0.001), but there were no significant differences between the two groups (P>0.05). Conclusion: Comparing with TOT, the single incision Needleless sling technique was a safe, effective treatment with fewer side effects and less complications.