A Prospective Multicenter Randomized Comparative Study Between the U- and H-type Methods of the TVT SECUR Procedure for the Treatment of Female Stress Urinary Incontinence: 1-Year Follow-Up

Abstract: Background: No studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure. Objective: Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence (SUI). Design, setting, and participants: Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study. Intervention: Subjects were randomly allocated to either the U- or H-type method of TVT-S. Measurements: Pre- and postoperative evaluations included a standing stress test, the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire, and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Patients’ satisfaction and complications were evaluated. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively. We compared the surgical outcomes between the two methods. Results and limitations: Of 285 women, 144 had the U-type method and 141 had the H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for the H-type method (p =0.091). Subjective cure rates were 77.1% for the U-type method and 75.7% for the H-type method (p =0.786). Improvement in I-QOL and domain scores of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients’ satisfaction favored the U-type method. There were three cases of intraoperative vaginal wall perforation, one case of increased bleeding, and three cases of temporary postoperative retention. A power calculation was not performed, and some baseline characteristics were not balanced between the two methods. Conclusions: Both methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method. Trial registration: The protocol of this study was not registered. [Copyright &y& Elsevier]