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document
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 ) . 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 .
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Intervention_Surgical
U- and H-type methods of the TVT SECUR procedure
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Intervention_Surgical
U- and H-type methods of the TVT SECUR ( TVT-S ) procedure .
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Intervention_Surgical
U- or H-type method of TVT-S.
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Intervention_Surgical
methods of TVT-S
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Intervention_Surgical
U-type method
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Outcome_Other
standing stress test
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Outcome_Other
Sandvik questionnaire
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Outcome_Other
Incontinence Quality of Life ( I-QOL ) questionnaire
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Outcome_Other
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms ( ICIQ-FLUTS )
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Outcome_Other
satisfaction
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Outcome_Adverse-effects
complications
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Outcome_Other
stress test
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Outcome_Other
Sandvik questionnaire
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Outcome_Other
Objective cure rates
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Outcome_Other
Subjective cure rates
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Outcome_Other
I-QOL and domain scores of the ICIQ-FLUTS ( filling and incontinence sum , QOL score )
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Outcome_Mental
patients ' satisfaction
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Outcome_Adverse-effects
intraoperative vaginal wall perforation
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Outcome_Adverse-effects
increased bleeding
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Outcome_Adverse-effects
temporary postoperative retention
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Outcome_Other
cure rates
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Outcome_Other
QOL
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Outcome_Other
treatment satisfaction
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Participant_Sex
female
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Participant_Condition
stress urinary incontinence
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Participant_Sex
female
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Participant_Condition
stress urinary incontinence ( SUI )
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Participant_Sex
Women
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Participant_Condition
urodynamic SUI
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Participant_Sample-size
285
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Participant_Sex
women
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Participant_Sample-size
144
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Participant_Sample-size
141
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Participant_Condition
SUI