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Study Title and Description

Tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: results of a multicentre randomised trial.

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 transobturator tape as surgery for stress urinary incontinence: results of a multicentre randomised trial.
Author	Porena M, Costantini E, Frea B, Giannantoni A, Ranzoni S, Mearini L, Bini V, Kocjancic E.
Country	--
Year	2007
Numbers	Pubmed ID: 17482343 1853 (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	Transobturator (Ob-Tape)		Comments ( 0 ) \| Post/View

Design Details
Question... Follow Up	Answer	Follow-up Answer
Country	Italy		Comments ( 0 ) \| Post/View
Outcome Categories Reported	Objective SUI		Comments ( 0 ) \| Post/View
	Subjective SUI		Comments ( 0 ) \| Post/View
	Quality of life		Comments ( 0 ) \| Post/View
	OR outcomes/complications (not "AEs")		Comments ( 0 ) \| Post/View
Population (reason for surgery etc.)	Symptomatic SUI		Comments ( 0 ) \| Post/View
	Intrinsic sphincter deficiency		Comments ( 0 ) \| Post/View
	Mixed incontinence		Comments ( 0 ) \| Post/View
RCT Comparison Category	Retropubic vs. Obturator		Comments ( 0 ) \| Post/View
Multicenter	Yes		Comments ( 0 ) \| Post/View
Institution Type	Academic hospital		Comments ( 0 ) \| Post/View
Number of surgeons performing procedures ...	Other ...	not clear total number	Comments ( 0 ) \| Post/View
Surgeons' Training	Urology		Comments ( 0 ) \| Post/View
Residents or fellows performing surgery?	Unclear/Not reported		Comments ( 0 ) \| Post/View
Study Quality (overall)	B (fair)		Comments ( 0 ) \| Flags ( 1 ) \| Post/View
Overall Study Notes	Interesting subanalysis provided for dry/improved/unchanged by vLPP </>60 and MUCP </>30 cm H2O		Comments ( 0 ) \| Post/View
Study Sponsor/Funding	Industry		Comments ( 0 ) \| Post/View

Baseline Characteristics

Question	TVT		Transobturator (Ob-Tape)		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	73		75								Comments ( 0 ) \| Post/View
Mean Age	61.8		60.6								Comments ( 0 ) \| Post/View
Post-Op Follow-Up Interval (Maximum)	32 mo (mean)		31 mo (mean)								Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

P-Value

Outcome: Transient voiding dysfunction Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 N/A	Counts	3	2			NS
0 N/A	N Enrolled	73	75

P-Value

Outcome: "Dry" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
31 months	Counts	50	58			NS
31 months	N Analyzed	70	75

P-Value

Outcome: "Wet - improved" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
31 months	Counts	13	10			NS
31 months	N Analyzed	70	75

P-Value

Outcome: "Wet - failure" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
31 months	Counts	7	7			NS
31 months	N Analyzed	70	75

P-Value

Outcome: Pad counts per day Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 months	N Enrolled	73	75
	Median	3	3
	Max	8	10
	Min	0	0
31 months	N Analyzed	70	75			NS
	Median	0	0
	Max	5	3
	Min	0	0
Within-Arm Comparisons
Comparison	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic
0 months vs. 31 months	N Analyzed	70	75
	Median Difference	-3	-3
	P-Value	<0.001	<0.001

P-Value P-Value

Outcome: UDI-6 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 months	Median	70	75			ND
	Max	8	10
	Min	19	21
	N Analyzed	0	2
31 months	Median	0	0			NS
	Max	21	21
	Min	0	0
	N Analyzed	70	75

P-Value P-Value

Outcome: IIQ-7 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 months	Median	8	8			ND
	Max	16	18
	Min	0	0
	N Analyzed	70	75
31 months	Median	0	0			NS
	Max	12	16
	Min	0	0
	N Analyzed	70	75

P-Value

Outcome: hospital stay Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 N/A	Median	1.5	1.3			NS
	Max	10	10
	Min	1	1
	N Enrolled	73	75

P-Value

Outcome: operative time Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 N/A	Median	30	20			NS
	Max	60	55
	Min	20	20
	N Enrolled	73	75

Extraction Form: Sling Adverse Events

Arms

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

Design Details
Question... Follow Up	Answer
Study Type	RCT	Comments ( 0 ) \| Post/View
Study Country	Italy	Comments ( 0 ) \| Post/View
Sling Category	Retropubic synthetic	Comments ( 0 ) \| Post/View
Sling Category	Obturator synthetic	Comments ( 0 ) \| Post/View
Institution Type	Academic hospital	Comments ( 0 ) \| Post/View
No. of Surgeons Performing the Procedures	Unclear/Not reported	Comments ( 0 ) \| Post/View
Surgeons' Training	Urology	Comments ( 0 ) \| Post/View
Residents or Fellows Performing the Surgery?	Unclear/Not reported	Comments ( 0 ) \| Post/View
Adverse Event Ascertainment	Active	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	Industry	Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

P-Value

Outcome: Transient voiding dysfunction Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 N/A	Counts	3	2			NS
0 N/A	N Enrolled	73	75

P-Value

Outcome: "Dry" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
31 months	Counts	50	58			NS
31 months	N Analyzed	70	75

P-Value

Outcome: "Wet - improved" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
31 months	Counts	13	10			NS
31 months	N Analyzed	70	75

P-Value

Outcome: "Wet - failure" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
31 months	Counts	7	7			NS
31 months	N Analyzed	70	75

P-Value

Outcome: Pad counts per day Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 months	N Enrolled	73	75
	Median	3	3
	Max	8	10
	Min	0	0
31 months	N Analyzed	70	75			NS
	Median	0	0
	Max	5	3
	Min	0	0
Within-Arm Comparisons
Comparison	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic
0 months vs. 31 months	N Analyzed	70	75
	Median Difference	-3	-3
	P-Value	<0.001	<0.001

P-Value P-Value

Outcome: UDI-6 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 months	Median	70	75			ND
	Max	8	10
	Min	19	21
	N Analyzed	0	2
31 months	Median	0	0			NS
	Max	21	21
	Min	0	0
	N Analyzed	70	75

P-Value P-Value

Outcome: IIQ-7 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 months	Median	8	8			ND
	Max	16	18
	Min	0	0
	N Analyzed	70	75
31 months	Median	0	0			NS
	Max	12	16
	Min	0	0
	N Analyzed	70	75

P-Value

Outcome: hospital stay Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 N/A	Median	1.5	1.3			NS
	Max	10	10
	Min	1	1
	N Enrolled	73	75

P-Value

Outcome: operative time Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Transobturator (Ob-Tape)	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT vs. Transobturator (Ob-Tape)
0 N/A	Median	30	20			NS
	Max	60	55
	Min	20	20
	N Enrolled	73	75

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	Mesh erosion/extrusion/exposure/granulation tissue	All 3 with Obtape required partial or complete removal 6mo-1yr postop	1 yr	After discharge	ND	ND	0	73	ND	ND	Comments ( 0 ) \| Post/View
Transobturator synthetic			1 yr	After discharge	ND	ND	3	75	ND
Total
Retropubic synthetic	Organ injury in OR (urethra, bladder, bowel)	Bladder	Intra-op	In-hospital	ND	ND	2	73	ND	NS	Comments ( 0 ) \| Post/View
Transobturator synthetic			Intra-op	In-hospital	ND	ND	1	75	ND
Total
Retropubic synthetic	Vaginal perforation	corrected by repeating manuever	Intra-op	In-hospital	ND	ND	0	73	ND	NS	Comments ( 0 ) \| Post/View
Transobturator synthetic			Intra-op	In-hospital	ND	ND	4	75	ND
Total
Retropubic synthetic	Bleeding	Retropubic hematoma	Peri-op	In-hospital	ND	ND	1	73	ND	ND	Comments ( 0 ) \| Post/View
Transobturator synthetic			Peri-op	In-hospital	ND	ND	0	75	ND
Total
Retropubic synthetic	Return to OR	Urethrolysis at 6mo	6 mo	After discharge	ND	ND	1	73	ND	ND	Comments ( 0 ) \| Post/View
Transobturator synthetic			6 mo	After discharge	ND	ND	0	75	ND
Total

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Tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: results of a multicentre randomised trial.

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