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.
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.
Lee
Kyu-Sung
KS
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Lee
Young-Suk
YS
Seo
Ju Tae
JT
Na
Yong Gil
YG
Choo
Myung-Soo
MS
Kim
Joon Chul
JC
Seo
Jun Hyoung
JH
Yoon
Jong Min
JM
Lee
Jeong Gu
JG
Kim
Duk Yoon
DY
Yoo
Eun Sang
ES
Min
Kweon Sik
KS
Hong
Jae Yup
JY
Lee
Jeong Zoo
JZ
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*