Retropubic tension-free vaginal tape and inside-out transobturator tape: a long-term randomized trial.
OBJECTIVE
The tension-free vaginal tape (TVT) and inside-out transobturator tape (TVT-O) are first-line surgical treatments for stress urinary incontinence (SUI). However, there is a lack of information regarding the long-term comparative safety of these procedures.


METHODS
A total of 140 SUI patients were randomized to the TVT or TVT-O procedure and were interviewed by an independent investigator at the follow-up. The primary outcomes were the proportions of patients with long-term postoperative complications. The secondary outcomes included the cure rates, quality of life (QOL) and sexual function based on validated questionnaires.


RESULTS
One hundred and twenty (85.71%) patients completed the long-term follow-up. More TVT patients experienced perioperative complications (P < 0.05). However, in a mean follow-up of 95 months, no significant between-group difference was found in the proportions of patients with long-term complications or in the variety of reported complications. The long-term complication rates for TVT and TVT-O were 43.1% and 27.4% respectively (P = 0.07). De novo voiding (15.8%) and storage symptoms (10.8%) were the primary long-term complications. Tape exposure was possible up to 7 years after TVT-O. The objective cure rates of TVT and TVT-O procedures were 79.30 and 69.35% respectively, which were not significantly higher than the subjective rates. The Pelvic Floor Impact Questionnaire (PFIQ-7) scores remained improved (P < 0.001) after both procedures, even at the 95-month follow-up. No difference was observed in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short Form (PISQ-12) scores after either procedure.


CONCLUSIONS
In the long term, the proportion of patients with complications and the cure rates of the two procedures did not differ significantly. The long-term complication rates were high, but morbidity was low, and the QOL remained improved.
Department of Gynecology and Obstetrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan, 100730, Dongcheng District, Beijing, People's Republic of China.
Zhibo
Z
Zhang
Department of Gynecology and Obstetrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan, 100730, Dongcheng District, Beijing, People's Republic of China. zhu_julie@vip.sina.com.
Lan
L
Zhu
Department of Epidemiology and Statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and School of Basic Medicine, Peking Union Medical College, Beijing, People's Republic of China.
Tao
T
Xu
Department of Gynecology and Obstetrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan, 100730, Dongcheng District, Beijing, People's Republic of China.
Jinghe
J
Lang
D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D053825:Suburethral Slings / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D014550:Urinary Incontinence, Stress / Q000601:surgery*
Complications; Inside-out transobturator tape; Long-term follow-up; Randomized controlled trial; Stress urinary incontinence; Tension-free vaginal tape