Articles

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

By: Kyu-Sung Leea, Young-Suk Leea, Ju Tae Seob, Yong Gil Nac, Myung-Soo Chood, Joon Chul Kime, Jun Hyoung Seof, Jong Min Yoong, Jeong Gu Leeh, Duk Yoon Kimi, Eun Sang Yooj, Kweon Sik Mink, Jae Yup Hongl and Jeong Zoo Leem lowast

Published online: 01 June 2010

Keywords: Female stress urinary incontinence, Randomized comparative study, TVT SECUR

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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.

Take Home Message

The U- and H-type methods of the TVT SECUR procedure provided comparable cure rates for female stress urinary incontinence. The U-type method showed more favorable results than the H-type method regarding quality of life and treatment satisfaction.

Keywords: Female stress urinary incontinence, Randomized comparative study, TVT SECUR.

Footnotes

a Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

b Cheil General Hospital & Women's Healthcare Center, Kwandong University College of Medicine, Seoul, Korea

c Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea

d Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

e Holy Family Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea

f CHA Medical Center, Pochon Cha University College of Medicine, Pochon, Korea

g Daehang Hospital, Seoul, Korea

h Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea

i Daegu Catholic University Medical Center, Daegu Catholic University College of Medicine, Daegu, Korea

j Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea

k Paik Institute of Clinical Research, Inje University College of Medicine, Busan, Korea

l Bundang Cha Hospital, Pochon CHA University College of Medicine, Seongnam, Korea

m Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea

lowast Corresponding author. 305 Gudeok-Ro, Seo-Gu, Pusan 602-739, South Korea. Tel. +82 51 240 7350; Fax: +82 51 255 7133.