Study Preview

Study Title and Description

One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective 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	One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial.
Author	Zullo MA., Plotti F., Calcagno M., Marullo E., Palaia I., Bellati F., Basile S., Muzii L., Angioli R., Panici PB.
Country	Department of Obstetrics and Gynecology, University of Rome Campus Bio-medico, Via Longoni 83, 00155 Rome, Italy. m.zullo@unicampus.it
Year	2007
Numbers	Pubmed ID: 17110021 14508 (internal)

Secondary Publication Information

UI	Title	Author	Country	Year
	Tension-free vaginal tape versus transobturator suburethral tape: five-year follow-up results of a prospective, randomised trial.	Angioli R., Plotti F., Muzii L., Montera R., Panici PB., Zullo MA.	Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Rome, Italy.	2010	Comments ( 0 ) \| Post/View

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
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
	Sexual function	Comments ( 0 ) \| Post/View
RCT Comparison Category	Retropubic vs. Obturator	Comments ( 0 ) \| Post/View

Baseline Characteristics

Question	TVT-O		TVT		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	37		35						72		Comments ( 0 ) \| Post/View
Mean Age	No data entered.
Post-Op Follow-Up Interval (Maximum)									60		Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

P-Value

Outcome: objective success SUI Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	72.9	71.4			1
60 months	Counts	27	25

P-Value

Outcome: Late complication rate Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Mean	5	5			1
	Standard Deviation
	Percentage	16.1	17.2

P-Value P-Value

Outcome: Prolapse stage 0 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	26	20			1
60 months	Counts	8	6
0 months	Percentage	30	26			1
0 months	Counts	11	9

P-Value P-Value

Outcome: Prolapse stage 1 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	79	80			0.77
60 months	Counts	25	23
0 months	Percentage	65	71			0.77
0 months	Counts	24	25

P-Value

Outcome: Dyspareunia Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	1	1			1
60 months	Counts

P-Value

Outcome: Chronic pelvic pain Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage					0.48
60 months	Counts	0	1

P-Value

Outcome: de novo urgency Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage					1
60 months	Counts	2	1

P-Value P-Value P-Value P-Value P-Value

Outcome: urinary frequency Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Percentage	0	0
0 months	Counts	0	0
12 months	Percentage	0	6			0.23
12 months	Counts	0	2
24 months	Percentage	0	0
24 months	Counts	0	0
48 months	Percentage	0	0
48 months	Counts	0	0
60 months	Percentage	0	0
60 months	Counts	0	0

P-Value P-Value P-Value P-Value P-Value

Outcome: urgency Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Percentage	0	0
0 months	Counts	0	0
12 months	Percentage	0	9			0.11
12 months	Counts	0	3
24 months	Percentage	0	0
24 months	Counts	0	0
48 months	Percentage	3	3			1
48 months	Counts	1	1
60 months	Percentage	6	3			1
60 months	Counts	2	1

P-Value P-Value P-Value P-Value P-Value

Outcome: nocturia Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Percentage	0	3			0.49
0 months	Counts	0	1
12 months	Percentage	0	0
12 months	Counts	0	0
24 months	Percentage	0	0
24 months	Counts	0	0
48 months	Percentage	0	0
48 months	Counts	0	0
60 months	Percentage	0	0
60 months	Counts	0	0

P-Value P-Value P-Value P-Value P-Value

Outcome: detrusor overactivity Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Percentage	0	0
0 months	Counts	0	0
12 months	Percentage	0	0
12 months	Counts	0	0
24 months	Percentage	0	0
24 months	Counts	0	0
48 months	Percentage	3	3			1
48 months	Counts	1	1
60 months	Percentage	3	3			1
60 months	Counts	1	1

P-Value

Outcome: Would undergo procedure again Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	78.4	62.8			0.0756
60 months	Counts	29	22

P-Value Statistical Test: P-Value Statistical Test:

Outcome: urethral hypermobility Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Mean	36.2	35.1			0.481
60 months	Standard Deviation	12.4	7.1
0 months	Mean	72.6	78.4			0.481
0 months	Standard Deviation	29.2	42.4

P-Value Statistical Test: P-Value Statistical Test:

Outcome: Urodynamics - peak flow Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Mean	26.6	25.8			0.23
0 months	Standard Deviation	5.5	6.3
60 months	Mean	22.7	21.8			0.23
60 months	Standard Deviation	3.4	3.3

P-Value Statistical Test: P-Value Statistical Test:

Outcome: Urodynamics - max cystometric capacity Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	ERROR vs. ERROR
60 months	Mean	483	473			0.457
60 months	Standard Deviation	55	52
0 months	Mean	473	468			0.457
0 months	Standard Deviation	56	49

P-Value Statistical Test: P-Value Statistical Test:

Outcome: Urodynamics - Detrusor pressure at peak flow Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Mean	18.2	17.3			0.44
0 months	Standard Deviation	7.2	7.9
60 months	Mean	16.2	16.8			0.44
60 months	Standard Deviation	7.2	5.8

P-Value Statistical Test: P-Value Statistical Test:

Outcome: Urodynamics - MUCP Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Mean	61.2	57.6			0.06
60 months	Standard Deviation	9.2	8.3
0 months	Mean	59.4	55			0.06
0 months	Standard Deviation	8.2	8.5

Outcome: Satisfaction with procedure Population: All Participants
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic
60 months	Mean
60 months	Standard Deviation
12 months	Mean
12 months	Standard Deviation

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	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

Results & Comparisons

Results Data

P-Value

Outcome: objective success SUI Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	72.9	71.4			1
60 months	Counts	27	25

P-Value

Outcome: Late complication rate Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Mean	5	5			1
	Standard Deviation
	Percentage	16.1	17.2

P-Value P-Value

Outcome: Prolapse stage 0 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	26	20			1
60 months	Counts	8	6
0 months	Percentage	30	26			1
0 months	Counts	11	9

P-Value P-Value

Outcome: Prolapse stage 1 Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	79	80			0.77
60 months	Counts	25	23
0 months	Percentage	65	71			0.77
0 months	Counts	24	25

P-Value

Outcome: Dyspareunia Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	1	1			1
60 months	Counts

P-Value

Outcome: Chronic pelvic pain Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage					0.48
60 months	Counts	0	1

P-Value

Outcome: de novo urgency Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage					1
60 months	Counts	2	1

P-Value P-Value P-Value P-Value P-Value

Outcome: urinary frequency Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Percentage	0	0
0 months	Counts	0	0
12 months	Percentage	0	6			0.23
12 months	Counts	0	2
24 months	Percentage	0	0
24 months	Counts	0	0
48 months	Percentage	0	0
48 months	Counts	0	0
60 months	Percentage	0	0
60 months	Counts	0	0

P-Value P-Value P-Value P-Value P-Value

Outcome: urgency Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Percentage	0	0
0 months	Counts	0	0
12 months	Percentage	0	9			0.11
12 months	Counts	0	3
24 months	Percentage	0	0
24 months	Counts	0	0
48 months	Percentage	3	3			1
48 months	Counts	1	1
60 months	Percentage	6	3			1
60 months	Counts	2	1

P-Value P-Value P-Value P-Value P-Value

Outcome: nocturia Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Percentage	0	3			0.49
0 months	Counts	0	1
12 months	Percentage	0	0
12 months	Counts	0	0
24 months	Percentage	0	0
24 months	Counts	0	0
48 months	Percentage	0	0
48 months	Counts	0	0
60 months	Percentage	0	0
60 months	Counts	0	0

P-Value P-Value P-Value P-Value P-Value

Outcome: detrusor overactivity Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Percentage	0	0
0 months	Counts	0	0
12 months	Percentage	0	0
12 months	Counts	0	0
24 months	Percentage	0	0
24 months	Counts	0	0
48 months	Percentage	3	3			1
48 months	Counts	1	1
60 months	Percentage	3	3			1
60 months	Counts	1	1

P-Value

Outcome: Would undergo procedure again Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Percentage	78.4	62.8			0.0756
60 months	Counts	29	22

P-Value Statistical Test: P-Value Statistical Test:

Outcome: urethral hypermobility Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Mean	36.2	35.1			0.481
60 months	Standard Deviation	12.4	7.1
0 months	Mean	72.6	78.4			0.481
0 months	Standard Deviation	29.2	42.4

P-Value Statistical Test: P-Value Statistical Test:

Outcome: Urodynamics - peak flow Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Mean	26.6	25.8			0.23
0 months	Standard Deviation	5.5	6.3
60 months	Mean	22.7	21.8			0.23
60 months	Standard Deviation	3.4	3.3

P-Value Statistical Test: P-Value Statistical Test:

Outcome: Urodynamics - max cystometric capacity Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	ERROR vs. ERROR
60 months	Mean	483	473			0.457
60 months	Standard Deviation	55	52
0 months	Mean	473	468			0.457
0 months	Standard Deviation	56	49

P-Value Statistical Test: P-Value Statistical Test:

Outcome: Urodynamics - Detrusor pressure at peak flow Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
0 months	Mean	18.2	17.3			0.44
0 months	Standard Deviation	7.2	7.9
60 months	Mean	16.2	16.8			0.44
60 months	Standard Deviation	7.2	5.8

P-Value Statistical Test: P-Value Statistical Test:

Outcome: Urodynamics - MUCP Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic	Comparison Measure	TVT-O vs. TVT
60 months	Mean	61.2	57.6			0.06
60 months	Standard Deviation	9.2	8.3
0 months	Mean	59.4	55			0.06
0 months	Standard Deviation	8.2	8.5

Outcome: Satisfaction with procedure Population: All Participants
Time Point	Measure	TVT-O	TVT	Retropubic synthetic	Transobturator synthetic
60 months	Mean
60 months	Standard Deviation
12 months	Mean
12 months	Standard Deviation

Adverse Events

Arm or Total	Title	Follow-up time	In-hospital or After discharge	Number affected	Number at risk (analyzed)	Reported P value between slings	Comments
Retropubic synthetic	Mesh erosion/extrusion/exposure/granulation tissue	60 mos	after	1	35	1	Comments ( 0 ) \| Post/View
Transobturator synthetic		60 mos	after	2	37	1
Total
Retropubic synthetic							Comments ( 0 ) \| Post/View
Transobturator synthetic
Total

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Study Preview

One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial.

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