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Study Title and Description

Comparison of TVT and TVT-O in patients with stress urinary incontinence: short-term cure rates and factors influencing the outcome. A prospective randomised study.

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	Comparison of TVT and TVT-O in patients with stress urinary incontinence: short-term cure rates and factors influencing the outcome. A prospective randomised study.
Author	Karateke A., Haliloglu B., Cam C., Sakalli M.
Country	Department of Obstetrics and Gynecology, Division of Urogynecology, Faculty of Medicine, Yeditepe University, Istanbul, Turkey.
Year	2009
Numbers	Pubmed ID: 19281588 32 (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-O		Comments ( 0 ) \| Post/View
2	TVT		Comments ( 0 ) \| Post/View

Design Details
Question... Follow Up	Answer	Follow-up Answer
Country ...	Other ...	Turkey	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.)	Urodynamic SUI		Comments ( 0 ) \| Post/View
Population (reason for surgery etc.)	Intrinsic sphincter deficiency		Comments ( 0 ) \| Post/View
RCT Comparison Category	Retropubic vs. Obturator		Comments ( 0 ) \| Post/View
Multicenter	Unclear/Not reported		Comments ( 0 ) \| Post/View
Institution Type	Academic hospital		Comments ( 0 ) \| Post/View
Number of surgeons performing procedures	1		Comments ( 0 ) \| Post/View
Surgeons' Training	Urogynecology		Comments ( 0 ) \| Post/View
Residents or fellows performing surgery?	Unclear/Not reported		Comments ( 0 ) \| Post/View
Study Quality (overall)	A (good)		Comments ( 0 ) \| Post/View
Overall Study Notes	Table6 of paper compares Cure, IIQ7, and UDI Q's 3-4 by subpopulations of vLPP</>60 and Qtip angle </>30. Comparisons are by vLPP and Qtip, not TVT-O vs TVT. Not sure how to capture these data since sub-population tables still want SlingA vs SlingB.		Comments ( 0 ) \| Post/View
Study Sponsor/Funding ...	Other ...	unclear	Comments ( 0 ) \| Post/View

Baseline Characteristics

Question	TVT-O		TVT		Transobturator synthetic		Retropubic synthetic		Total		Comments
Question	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Comments
No. Randomized	84		83								Comments ( 0 ) \| Post/View
Mean Age	49		49								Comments ( 0 ) \| Post/View
Post-Op Follow-Up Interval (Maximum)									14 mo		Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

P-Value

Outcome: EBL <200mL Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Enrolled	83	81			0.207
	Counts	82	77
	Percentage	98.8	95.1

P-Value

Outcome: EBL >200 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Enrolled	83	81			0.207
	Counts	1	4
	Percentage	1.2	4.9

P-Value

Outcome: "Cure" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.675
	Counts	72	72
	Percentage	86.7	88.9

P-Value

Outcome: Short-term catheterization Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Enrolled	83	81			0.544
	Counts	6	8
	Percentage	7.2	9.9

P-Value

Outcome: De novo DO Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.603
	Counts	10	12
	Percentage	12.0	14.8

P-Value

Outcome: De novo UUI Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.723
	Counts	5	6
	Percentage	6.0	7.4

P-Value

Outcome: Very satisfied Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.826
	Counts	69	68
	Percentage	83.1	84.0

P-Value

Outcome: Satisfied Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.826
	Counts	7	8
	Percentage	8.4	9.9

P-Value

Outcome: Time in OR Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Analyzed	83	81			0.001
	Mean	16.64	31.27
	Standard Deviation	2.47	4.73

P-Value

Outcome: Time in hospital Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Analyzed	83	81			0.290
	Mean	1.25	1.36
	Standard Deviation	0.66	0.76

P-Value

Outcome: Time 'til normal acitivities Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Analyzed	83	81			0.367
	Mean	2.43	2.70
	Standard Deviation	2.02	2.40

Outcome: PVR Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	10.96	11.05
	Standard Deviation	5.60	5.90
12 months	N Analyzed	83	81
	Mean	24.28	25.37
	Standard Deviation	12.76	13.27

Outcome: IIQ-7 Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	13.83	13.83
	Standard Deviation	3.88	3.88
12 months	N Analyzed	83	81
	Mean	6.88	6.94
	Standard Deviation	3.38	3.40

Outcome: IIQ-7 Population: vLPP<60
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
12 months	N Analyzed
	Mean
	Standard Deviation

Outcome: UDI Q's1-2 Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	1.00	1.04
	Standard Deviation	0.81	0.83
12 months	N Analyzed	83	81
	Mean	1.54	1.60
	Standard Deviation	0.91	0.93

Outcome: UDI Q's3-4 Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	4.24	4.22
	Standard Deviation	1.36	1.36
12 months	N Analyzed	83	81
	Mean	1.00	0.89
	Standard Deviation	1.06	0.87

Outcome: UDI Q's5-6 Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	0.75	0.75
	Standard Deviation	0.87	0.83
12 months	N Analyzed	83	81
	Mean	0.76	0.93
	Standard Deviation	1.11	1.19

Extraction Form: Sling Adverse Events

Arms

Number	Title	Description	Comments
1	Transobturator synthetic	TVT-O	Comments ( 0 ) \| Post/View
2	Retropubic synthetic	TVT	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	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	Not reported	Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

P-Value

Outcome: EBL <200mL Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Enrolled	83	81			0.207
	Counts	82	77
	Percentage	98.8	95.1

P-Value

Outcome: EBL >200 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Enrolled	83	81			0.207
	Counts	1	4
	Percentage	1.2	4.9

P-Value

Outcome: "Cure" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.675
	Counts	72	72
	Percentage	86.7	88.9

P-Value

Outcome: Short-term catheterization Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Enrolled	83	81			0.544
	Counts	6	8
	Percentage	7.2	9.9

P-Value

Outcome: De novo DO Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.603
	Counts	10	12
	Percentage	12.0	14.8

P-Value

Outcome: De novo UUI Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.723
	Counts	5	6
	Percentage	6.0	7.4

P-Value

Outcome: Very satisfied Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.826
	Counts	69	68
	Percentage	83.1	84.0

P-Value

Outcome: Satisfied Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
12 months	N Enrolled	83	81			0.826
	Counts	7	8
	Percentage	8.4	9.9

P-Value

Outcome: Time in OR Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Analyzed	83	81			0.001
	Mean	16.64	31.27
	Standard Deviation	2.47	4.73

P-Value

Outcome: Time in hospital Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Analyzed	83	81			0.290
	Mean	1.25	1.36
	Standard Deviation	0.66	0.76

P-Value

Outcome: Time 'til normal acitivities Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic	Comparison Measure	TVT-O vs. TVT
0 months	N Analyzed	83	81			0.367
	Mean	2.43	2.70
	Standard Deviation	2.02	2.40

Outcome: PVR Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	10.96	11.05
	Standard Deviation	5.60	5.90
12 months	N Analyzed	83	81
	Mean	24.28	25.37
	Standard Deviation	12.76	13.27

Outcome: IIQ-7 Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	13.83	13.83
	Standard Deviation	3.88	3.88
12 months	N Analyzed	83	81
	Mean	6.88	6.94
	Standard Deviation	3.38	3.40

Outcome: IIQ-7 Population: vLPP<60
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
12 months	N Analyzed
	Mean
	Standard Deviation

Outcome: UDI Q's1-2 Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	1.00	1.04
	Standard Deviation	0.81	0.83
12 months	N Analyzed	83	81
	Mean	1.54	1.60
	Standard Deviation	0.91	0.93

Outcome: UDI Q's3-4 Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	4.24	4.22
	Standard Deviation	1.36	1.36
12 months	N Analyzed	83	81
	Mean	1.00	0.89
	Standard Deviation	1.06	0.87

Outcome: UDI Q's5-6 Population: All Participants
Time Point	Measure	TVT-O	TVT	Transobturator synthetic	Retropubic synthetic
0 months	N Analyzed	83	81
	Mean	0.75	0.75
	Standard Deviation	0.87	0.83
12 months	N Analyzed	83	81
	Mean	0.76	0.93
	Standard Deviation	1.11	1.19

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
Transobturator synthetic	Organ injury in OR (urethra, bladder, bowel)	bladder; TVT-O did not actually have cysto	Intra-op	In-hospital	ND	ND	0	83	ND	0.118	Comments ( 0 ) \| Post/View
Retropubic synthetic			Intra-op	In-hospital	ND	ND	3	81	ND
Total
Transobturator synthetic	Organ injury in OR (urethra, bladder, bowel)	Vascular injury	Intra-op	In-hospital	ND	ND	0	83	ND	NS	Comments ( 0 ) \| Post/View
Retropubic synthetic			Intra-op	In-hospital	ND	ND	0	81	ND
Total
Transobturator synthetic	Hematoma		Intra-op	In-hospital	ND	ND	2	83	ND	0.440	Comments ( 0 ) \| Post/View
Retropubic synthetic			Intra-op	In-hospital	ND	ND	4	81	ND
Total
Transobturator synthetic	Fever		Unclear	In-hospital	ND	ND	1	83	ND	0.364	Comments ( 0 ) \| Post/View
Retropubic synthetic			Unclear	In-hospital	ND	ND	4	81	ND
Total
Transobturator synthetic	Mesh erosion/extrusion/exposure/granulation tissue		12mo	After discharge	ND	ND	2	83	ND	0.440	Comments ( 0 ) \| Post/View
Retropubic synthetic			12mo	After discharge	ND	ND	4	81	ND
Total

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Study Preview

Comparison of TVT and TVT-O in patients with stress urinary incontinence: short-term cure rates and factors influencing the outcome. A prospective randomised study.

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