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Study Title and Description

Tension-free vaginal tape versus tension-free vaginal tape obturator (inside-outside) in the surgical treatment of female stress urinary incontinence.

Key Questions Addressed

1	Sling vs Comparator RCT outcomes (excluding AEs)	Comments ( 0 ) \| Post/View
2	Sling Adverse Events	Comments ( 0 ) \| Post/View

Primary Publication Information

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Title	Data
Title	Tension-free vaginal tape versus tension-free vaginal tape obturator (inside-outside) in the surgical treatment of female stress urinary incontinence.
Author	Aniuliene R.
Country	Department of Obstetrics and Gynecology, Kaunas University of Medicine, Eiveniu 2, Kaunas 50009, Lithuania. rositaan@hotmail.com
Year	2009
Numbers	Pubmed ID: 19773623 679 (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	TVT		Comments ( 0 ) \| Post/View
2	TVT-O		Comments ( 0 ) \| Post/View

Design Details
Question... Follow Up	Answer	Follow-up Answer
Country ...	Other ...	Lithuania	Comments ( 0 ) \| Post/View
Outcome Categories Reported	Objective SUI		Comments ( 0 ) \| Post/View
	Subjective SUI		Comments ( 0 ) \| Post/View
	OR outcomes/complications (not "AEs")		Comments ( 0 ) \| Post/View
Population (reason for surgery etc.)	Symptomatic SUI		Comments ( 0 ) \| Post/View
RCT Comparison Category	Retropubic vs. Obturator		Comments ( 0 ) \| Post/View
Multicenter	No		Comments ( 0 ) \| Post/View
Institution Type	Academic hospital		Comments ( 0 ) \| Post/View
Number of surgeons performing procedures	1		Comments ( 0 ) \| Post/View
Surgeons' Training	Not reported		Comments ( 0 ) \| Post/View
Residents or fellows performing surgery?	Unclear/Not reported		Comments ( 0 ) \| Post/View
Study Quality (overall)	C (poor)		Comments ( 0 ) \| Post/View
Study Sponsor/Funding ...	Other ...	Unclear	Comments ( 0 ) \| Post/View

Baseline Characteristics

Question	TVT		TVT-O		Retropubic synthetic		Transobturator synthetic		Total		Comments
Question	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Comments
No. Randomized	114		150								Comments ( 0 ) \| Post/View
Mean Age	51		49.9								Comments ( 0 ) \| Post/View
Post-Op Follow-Up Interval (Maximum)	12 mo		12 mo								Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

P-Value

Outcome: "Excellent" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	N Enrolled	114	150			NS
	Counts	97	117
	Percentage	85.1	78

P-Value

Outcome: "Good" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	N Enrolled	114	150			NS
	Counts	11	25
	Percentage	9.7	16.7

P-Value

Outcome: "Moderate" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	N Enrolled	114	150			NS
	Counts	3	5
	Percentage	2.6	3.3

P-Value

Outcome: "Bad" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	N Enrolled	114	150			NS
	Counts	3	3
	Percentage	2.6	2

P-Value

Outcome: Time in OR Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
0 months	N Analyzed	114	150			<0.05
	Mean	27	19
	Standard Deviation	7.1	5.6

P-Value

Outcome: Time in hospital Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
0 months	N Analyzed	114	150			<0.05
	Mean	4.0	1.5
	Standard Deviation	1.6	0.5

P-Value

Outcome: "Effectiveness" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	Mean	94.6	94.6			>0.05

Extraction Form: Sling Adverse Events

Arms

Number	Title	Description	Comments
1	Retropubic synthetic		Comments ( 0 ) \| Post/View
2	Transobturator synthetic		Comments ( 0 ) \| Post/View

Design Details
Question... Follow Up	Answer
Study Type	RCT	Comments ( 0 ) \| Post/View
Sling Category	Retropubic synthetic	Comments ( 0 ) \| Post/View
Sling Category	Obturator synthetic	Comments ( 0 ) \| Post/View
Adverse Event Ascertainment	Unclear/Not reported	Comments ( 0 ) \| Post/View
Was the Clavien-Dindo Classification of Surgical Complications system used?	No / Not reported	Comments ( 0 ) \| Post/View
Was a data safety monitoring board used?	No / Not reported	Comments ( 0 ) \| Post/View
Study Sponsor/Funding	Not reported	Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

P-Value

Outcome: "Excellent" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	N Enrolled	114	150			NS
	Counts	97	117
	Percentage	85.1	78

P-Value

Outcome: "Good" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	N Enrolled	114	150			NS
	Counts	11	25
	Percentage	9.7	16.7

P-Value

Outcome: "Moderate" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	N Enrolled	114	150			NS
	Counts	3	5
	Percentage	2.6	3.3

P-Value

Outcome: "Bad" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	N Enrolled	114	150			NS
	Counts	3	3
	Percentage	2.6	2

P-Value

Outcome: Time in OR Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
0 months	N Analyzed	114	150			<0.05
	Mean	27	19
	Standard Deviation	7.1	5.6

P-Value

Outcome: Time in hospital Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
0 months	N Analyzed	114	150			<0.05
	Mean	4.0	1.5
	Standard Deviation	1.6	0.5

P-Value

Outcome: "Effectiveness" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	TVT-O	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. TVT-O
12 months	Mean	94.6	94.6			>0.05

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
Retropubic synthetic	Infection, UTI		Unclear	After discharge	ND	ND	5	114	ND	NS	Comments ( 0 ) \| Post/View
Transobturator synthetic			Unclear	After discharge	ND	ND	1	150	ND
Total
Retropubic synthetic	Suprapubic hematoma		Unclear	Unclear	ND	ND	1	114	ND	NS	Comments ( 0 ) \| Post/View
Transobturator synthetic			Unclear	Unclear	ND	ND	0	150	ND
Total
Retropubic synthetic	Organ injury in OR (urethra, bladder, bowel)	Bladder perforation	Intraop	In-hospital	ND	ND	1	114	ND	ND	Comments ( 0 ) \| Post/View
Transobturator synthetic			Intraop	In-hospital	ND	ND	0	150	ND
Total
Retropubic synthetic	Postop retention	not defined	Unclear	Unclear	ND	ND	18	114	ND	<0.05	Comments ( 0 ) \| Post/View
Transobturator synthetic			Unclear	Unclear	ND	ND	5	150	ND
Total
Retropubic synthetic	"Irritated bladder"		Unclear	Unclear	ND	ND	6	114	ND	NS	Comments ( 0 ) \| Post/View
Transobturator synthetic			Unclear	Unclear	ND	ND	5	150	ND
Total
Retropubic synthetic	fever	>38	Unclear	Unclear	ND	ND	0	114	ND	NS	Comments ( 0 ) \| Post/View
Transobturator synthetic			Unclear	Unclear	ND	ND	1	150	ND
Total

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Tension-free vaginal tape versus tension-free vaginal tape obturator (inside-outside) in the surgical treatment of female stress urinary incontinence.

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