IJSR International Journal of Scientific Research 2277 - 8179 Indian Society for Health and Advanced Research ijsr-9-4-24965 Original Research Paper MANAGEMENT OF STRESS URINARY INCONTINENCE IN WOMEN : SINGLE INCISION DEVICE (TVT SECUR) VERSUS RETROPUBIC TENSION-FREE VAGINAL TAPE DEVICE (TVT), A RANDOMIZED CLINICAL TRIAL IN TERTIARY CARE CENTRE Deepak Kumar Dr. April 2020 9 4 01 02 ABSTRACT

Purpose: We aim to present our experience to compare the effectiveness of the new TVT Secur sling device to that of the established retropubic TVT device at 12 months postoperatively, with the primary outcome being objective “cure” (urine leakage less than 1 g) measured using a standardized pad test. Materials and Methods: Our study was designed as a parallel group randomized trial with follow up of participants at one year postoperatively. From January 2016 to Mar 2018, 74 stress urinary incontinent patients who underwent retropubic procedure using either a TVT Secur sling device (“TVT Secur Group”) or the TVT tension–free vaginal tape device (“TVT Group”) were followed up 12 months after the surgery. Outcome in the form of objective and subjective cure, complication and adverse events, incontinence related quality of life, sexual function and satisfaction with surgical outcomes were analysed. Results: Forty women were randomly allocated to the TVT Secur Group and 34 to the TVT Group. A total of 68 (92%) were followed up at 12 months. Duration of operation was similar for both groups (TVT Secur Group median 18 minutes versus TVT Group median 21 minutes). Of women in the TVT Secur Group who had a pad test, 27/33 (82%) were “cured”, compared to 25/28 (89%) in the TVT Group. Conclusion: The TVT Secur device improves patient outcomes and ease of use for surgeons, often by simplifying procedures while reducing operating room time. Our small randomized trial did not find statistically significant differences in outcomes (cure, adverse events, or quality of life) between women allocated to having a TVT Secur versus those allocated to having an established TVT procedure for stress urinary incontinence. Our experience also highlights the need for more larger trial, so that surgeons and their patients are confident in the effectiveness and safety of TVT Secur device