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Study Title and Description

Randomized comparison of the suprapubic arc sling procedure vs tension-free vaginal taping for stress incontinent women.



Key Questions Addressed
1 Sling vs Comparator RCT outcomes (excluding AEs)
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2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Randomized comparison of the suprapubic arc sling procedure vs tension-free vaginal taping for stress incontinent women.
Author Tseng LH., Wang AC., Lin YH., Li SJ., Ko YJ.
Country Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics/Gynecology, Chang Gung University Hospital, Guei-shan Tao-yuan, Taiwan.
Year -- Not Found --
Numbers Pubmed ID: 15875240
71 (internal)

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


Extraction Form: Sling vs Comparator RCT outcomes (excluding AEs)
Arms
Number Title Description Comments
1 SPARC • SPARC as described by Plzak and Staskin
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2 TVT TVT – as per standard technique described by Ulmsten
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Design Details
Question... Follow Up Answer Follow-up Answer
Country ... Other ... Taiwan
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Outcome Categories Reported Objective SUI
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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Urodynamic SUI
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RCT Comparison Category ... Other comparison ... retropubic SPARC vs. retropubic TVT
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Multicenter No
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Institution Type Academic hospital
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Number of surgeons performing procedures 1
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Surgeons' Training Urogynecology
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Residents or fellows performing surgery? No
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Study Quality (overall) B (fair)
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Overall Study Notes Multiple soft red flags: out of 72 consecutive slings, 62 met inclusion criteria and were randomized, that means no pts declined to participate. Computer generated randomization, but exactly equal number of patients in 2 arms. There are no missing data, suspicious given a lack of info regarding how these datapoints were defined or collected.
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Study Sponsor/Funding ... Other ... none listed so I assume academia
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Baseline Characteristics
Question SPARC TVT SPARC TVT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized 31 31
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Mean Age 50.43yr 51.57yr
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Post-Op Follow-Up Interval (Maximum) 2yr 2yr
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Nocturia      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 2 1
Standard Deviation
1.00


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Enrolled
Counts
Standard Deviation
.


2 years

N Enrolled 31 31
Counts 5 3
Standard Deviation
.706
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 5 3
Standard Deviation
.706


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 31 31
Counts 5 2
Standard Deviation
.424
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Dysuria      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 1 0
Standard Deviation
1.000


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Incomplete voiding      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 31 31
Counts 10 6
Standard Deviation
.382
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Strain to void      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 3 2
Standard Deviation
1.000


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Post-micturition dribble      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure ERROR vs. ERROR


0 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 31 31
Counts 4 0
Standard Deviation
.112
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective cured pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 25 27
Standard Deviation
.706


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective improved pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure ERROR vs. ERROR


0 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 31 31
Counts 6 4
Standard Deviation
.706
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Operation time      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Analyzed 31 31
Mean 40.77min 32.74min
Standard Deviation
.779


2 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Hospital days      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Analyzed 31 31
Mean 3.97d 3.14d
Standard Deviation
.030


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Blood loss      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Analyzed 31
Mean 135.83 106.00
Standard Deviation
.510


2 years

N Analyzed
Mean
Standard Deviation


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 SPARC
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2 TVT
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Study Country ... Other ... Taiwan
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Sling Category Retropubic synthetic
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Multicenter? No
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures 1
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Surgeons' Training Urogynecology
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Residents or Fellows Performing the Surgery? No
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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 ... I assume academia
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Not reported
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Results & Comparisons


Results Data
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation
Outcome: Nocturia      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 2 1
Standard Deviation
1.00


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Frequency      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Enrolled
Counts
Standard Deviation
.


2 years

N Enrolled 31 31
Counts 5 3
Standard Deviation
.706
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Urgency      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 5 3
Standard Deviation
.706


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Urge incontinence      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 31 31
Counts 5 2
Standard Deviation
.424
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Dysuria      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 1 0
Standard Deviation
1.000


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Incomplete voiding      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 31 31
Counts 10 6
Standard Deviation
.382
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Strain to void      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 3 2
Standard Deviation
1.000


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: Post-micturition dribble      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure ERROR vs. ERROR


0 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 31 31
Counts 4 0
Standard Deviation
.112
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective cured pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Enrolled 31 31
Counts 25 27
Standard Deviation
.706


0 years

N Enrolled
Counts
Standard Deviation
Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation P-Value
Outcome: SUI objective improved pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure ERROR vs. ERROR


0 years

N Enrolled
Counts
Standard Deviation


2 years

N Enrolled 31 31
Counts 6 4
Standard Deviation
.706
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation
Outcome: Operation time      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Analyzed 31 31
Mean 40.77min 32.74min
Standard Deviation
.779


2 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Hospital days      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


2 years

N Analyzed 31 31
Mean 3.97d 3.14d
Standard Deviation
.030


0 years

N Analyzed
Mean
Standard Deviation
N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation P-Value
Outcome: Blood loss      Population: All Participants Between-Arm Comparisons
Time Point Measure SPARC TVT SPARC TVT Comparison Measure SPARC vs. TVT


0 years

N Analyzed 31
Mean 135.83 106.00
Standard Deviation
.510


2 years

N Analyzed
Mean
Standard Deviation

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
SPARC Organ injury in OR (urethra, bladder, bowel) Bladder Injury 4 31 .112
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TVT 0 31
Total
SPARC Retropubic hematoma(>/= 5cm) 3 31 .706
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TVT 5 31
Total
SPARC REjection of tape Rejection of tape was considered as including persistent defective healing of the vaginal wound despite debridement, exposure of the suburethral portion of the tape, spontaneous healing of the vaginal wound after removal of the exposed tape, and evidence of prosthesis rejection reaction demonstrated by immunohistochemical evaluation 1 31 1.00
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TVT 2 31
Total
SPARC Defective vaginal wound healing Defective vaginal wound healing was defined as presentation of granulation background on the site of the polypropylene tape implantation in the anterior vaginal wall. 1 31 .612
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TVT 3 31
Total
SPARC Protrusion of tape edge Protrusion of the tape edge was defined as healing of the vaginal wound without any visible granulation background, with part of the unbound selvage edge of the tape being visible on the suburethral implantation site. 1 31 .112
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TVT 4 31
Total
SPARC
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TVT
Total