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Study Title and Description

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.



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
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.
Author Lee KS, Lee YS, Seo JT, Na YG, Choo MS, Kim JC, Seo JH, Yoon JM, Lee JG, Kim DY, Yoo ES, Min KS, Hong JY, Lee JZ.
Country Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Year 2010
Numbers Pubmed ID: 20206437
1076 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Minisling retropubic TVT-Secur U
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2 Minisling obturator TVT-Secur H
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Name Comparison of mini-slings
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Study Country South Korea
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Sling Category Minisling H (obturator)
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Minsling U (retropubic)
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Multicenter? Yes
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Institution Type Unclear/Not reported
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No. of Surgeons Performing the Procedures ... Other ... 13
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Surgeons' Training Not reported
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Unclear/Not reported
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Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding ... Other ... none listed
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Comments (overall study) Poor reporting of AEs
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Follow-up time In-hospital or After discharge Is event serious? Reported definition of serious event Number affected Number at risk (analyzed) Difference between 2 slings (eg, OR/RR or %, with 95% CI) Reported P value between slings Comments
Minisling retropubic lateral vaginal wall perforation in OR in hospital not listed not listed 3 141 not listed not listed
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Minisling obturator 0 144
Total
Minisling retropubic Transfusion post-op in OR in hospital yes not listed 1 141 not listed not listed
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Minisling obturator 0 144
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Minisling retropubic urinary retention requiring catheter 2 days post op after discharge not listed not listed 3 141 not listed not listed
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Minisling obturator 2 144
Total
Minisling retropubic de novo urgency up to 12 months after discharge not listed not listed 7.6% 141 not listed 0.858
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Minisling obturator 7% 144
Total
Minisling retropubic Mesh erosion/extrusion/exposure/granulation tissue up to 12 months after discharge not listed not listed 0 141 not listed not listed
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Minisling obturator 0 144
Total
Minisling retropubic Organ injury in OR (urethra, bladder, bowel) in OR in hospital not listed not listed 0 141 not listed not listed
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Minisling obturator 0 144
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Minisling retropubic dyspareunia up to 12 months after discharge not listed not listed 0 141 not listed not listed
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Minisling obturator 0 144
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