title: 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).
  
  
  METHODS
  Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study.
  
  
  METHODS
  Subjects were randomly allocated to either the U- or H-type method of TVT-S.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The protocol of this study was not registered.
authors.affiliation: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Kyu-Sung
authors.initials: KS
authors.lastname: Lee
authors.forename: Young-Suk
authors.initials: YS
authors.lastname: Lee
authors.forename: Ju Tae
authors.initials: JT
authors.lastname: Seo
authors.forename: Yong Gil
authors.initials: YG
authors.lastname: Na
authors.forename: Myung-Soo
authors.initials: MS
authors.lastname: Choo
authors.forename: Joon Chul
authors.initials: JC
authors.lastname: Kim
authors.forename: Jun Hyoung
authors.initials: JH
authors.lastname: Seo
authors.forename: Jong Min
authors.initials: JM
authors.lastname: Yoon
authors.forename: Jeong Gu
authors.initials: JG
authors.lastname: Lee
authors.forename: Duk Yoon
authors.initials: DY
authors.lastname: Kim
authors.forename: Eun Sang
authors.initials: ES
authors.lastname: Yoo
authors.forename: Kweon Sik
authors.initials: KS
authors.lastname: Min
authors.forename: Jae Yup
authors.initials: JY
authors.lastname: Hong
authors.forename: Jeong Zoo
authors.initials: JZ
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D018709:Statistics, Nonparametric; D053825:Suburethral Slings; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000379:methods*