Study Preview

Study Title and Description

A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for 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

Comments (
0
) |
Post/View

Title	Data
Title	A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female stress urinary incontinence.
Author	Téllez Martínez-Fornés M., Fernández Pérez C., Fouz López C., Fernández Lucas C., Borrego Hernando J.
Country	Urology Department, Severo Ochoa Hospital, Leganés, Madrid, Spain. migueltellez@hotmail.com
Year	2009
Numbers	Pubmed ID: 20096179 980 (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	Burch		Comments ( 0 ) \| Post/View

Design Details
Question... Follow Up	Answer	Follow-up Answer
Country	Spain		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
	Urodynamic SUI		Comments ( 0 ) \| Post/View
	Intrinsic sphincter deficiency		Comments ( 0 ) \| Post/View
RCT Comparison Category	Sling vs. Burch		Comments ( 0 ) \| Post/View
Multicenter	No		Comments ( 0 ) \| Post/View
Institution Type	Unclear/Not reported		Comments ( 0 ) \| Post/View
Number of surgeons performing procedures ...	Other ...	at least 2 (2 Urologists did TVT, ? did Burch)	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 ) \| Post/View
Study Sponsor/Funding ...	Other ...	Unclear	Comments ( 0 ) \| Post/View

Baseline Characteristics

Question	TVT		Burch		Retropubic synthetic		Burch		Total		Comments
Question	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Comments
No. Randomized	24		25								Comments ( 0 ) \| Post/View
Mean Age	47.13		50.0								Comments ( 0 ) \| Post/View
Post-Op Follow-Up Interval (Maximum)	3 yr		3 yr								Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI) P-Value Risk Ratio (RR) 95% Confidence Interval Lower Limit (95% LCI) 95% Confidence Interval Upper Limit (95% HCI)

Outcome: Positive 1hr pad test Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
12 months	N Enrolled	23	24			0.97
	Counts	1	1			0.96
	Percentage	4.3	4.2			0.06
						16.25
36 months	N Enrolled	21	23			0.55
	Counts	3	2			0.57
	Percentage	15	9.1			0.08
						3.40

P-Value P-Value

Outcome: "Cure" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
12 months	N Enrolled	23	24			0.19
	Counts	14	16
	Percentage	60.9	66.7
36 months	N Enrolled	21	23			0.19
	Counts	14	16
	Percentage	63.6	69.6

P-Value P-Value

Outcome: "Improvement" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
12 months	N Enrolled	23	24			0.19
	Counts	4	5
	Percentage	17.4	20.8
36 months	N Enrolled	21	23			0.19
	Counts	3	5
	Percentage	13.6	21.7

P-Value P-Value

Outcome: "Failure" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
12 months	N Enrolled	23	24			0.19
	Counts	5	3
	Percentage	21.7	12.5
36 months	N Enrolled	21	23			0.19
	Counts	5	2
	Percentage	22.7	8.7

P-Value P-Value P-Value

Outcome: ISI score Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			0.52
	Mean	16.26	16.67
	Standard Deviation	2.22	2.18
12 months	N Analyzed	23	24			NS
	Mean	0.83	1.5
	Standard Deviation	?	~3.5
36 months	N Analyzed	21	23			NS
	Mean	1.0	1.8
	Standard Deviation	~2.5	~4.0
Within-Arm Comparisons
Comparison	Measure	TVT	Burch	Retropubic synthetic	Burch
0 months vs. 12 months	P-Value	<0.05	<0.05
12 months vs. 36 months	P-Value	NS	NS

P-Value P-Value P-Value

Outcome: IIQ score Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			0.19
	Median	4	7
	25th Percentile	2	4
	75th Percentile	8	9
12 months	N Analyzed	23	24			NS
	Mean	0.2	0.67
	Standard Deviation	~4.3	~4.3
36 months	N Analyzed	21	23			NS
	Mean	0.55	0.35
	Standard Deviation	~4.8	~4.3

P-Value

Outcome: Time in hospital Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			<0.0001
	Median	1	3
	25th Percentile	1	3
	75th Percentile	2	3

P-Value

Outcome: Time in OR Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			0.003
	Mean	41.1	57.1
	Standard Deviation	10.9	18.3

P-Value

Outcome: Analgesia # doses Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			<0.0001
	Median	6	23.5
	25th Percentile	2.8	18
	75th Percentile	10.5	31.5

P-Value

Outcome: Cost Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			0.599
	Mean	2231	2125
	Standard Deviation	445.33	569.99

Extraction Form: Sling Adverse Events

Arms

Number	Title	Description	Comments
1	Retropubic synthetic		Comments ( 0 ) \| Post/View
2	Burch	Two #1 Ethibond on each side	Comments ( 0 ) \| Post/View

Design Details
Question... Follow Up	Answer	Follow-up Answer
Study Type	RCT		Comments ( 0 ) \| Post/View
Sling Category	Retropubic synthetic		Comments ( 0 ) \| Post/View
Sling Category	Other ...	Burch	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

Outcome: Positive 1hr pad test Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
12 months	N Enrolled	23	24			0.97
	Counts	1	1			0.96
	Percentage	4.3	4.2			0.06
						16.25
36 months	N Enrolled	21	23			0.55
	Counts	3	2			0.57
	Percentage	15	9.1			0.08
						3.40

P-Value P-Value

Outcome: "Cure" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
12 months	N Enrolled	23	24			0.19
	Counts	14	16
	Percentage	60.9	66.7
36 months	N Enrolled	21	23			0.19
	Counts	14	16
	Percentage	63.6	69.6

P-Value P-Value

Outcome: "Improvement" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
12 months	N Enrolled	23	24			0.19
	Counts	4	5
	Percentage	17.4	20.8
36 months	N Enrolled	21	23			0.19
	Counts	3	5
	Percentage	13.6	21.7

P-Value P-Value

Outcome: "Failure" Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
12 months	N Enrolled	23	24			0.19
	Counts	5	3
	Percentage	21.7	12.5
36 months	N Enrolled	21	23			0.19
	Counts	5	2
	Percentage	22.7	8.7

P-Value P-Value P-Value

Outcome: ISI score Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			0.52
	Mean	16.26	16.67
	Standard Deviation	2.22	2.18
12 months	N Analyzed	23	24			NS
	Mean	0.83	1.5
	Standard Deviation	?	~3.5
36 months	N Analyzed	21	23			NS
	Mean	1.0	1.8
	Standard Deviation	~2.5	~4.0
Within-Arm Comparisons
Comparison	Measure	TVT	Burch	Retropubic synthetic	Burch
0 months vs. 12 months	P-Value	<0.05	<0.05
12 months vs. 36 months	P-Value	NS	NS

P-Value P-Value P-Value

Outcome: IIQ score Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			0.19
	Median	4	7
	25th Percentile	2	4
	75th Percentile	8	9
12 months	N Analyzed	23	24			NS
	Mean	0.2	0.67
	Standard Deviation	~4.3	~4.3
36 months	N Analyzed	21	23			NS
	Mean	0.55	0.35
	Standard Deviation	~4.8	~4.3

P-Value

Outcome: Time in hospital Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			<0.0001
	Median	1	3
	25th Percentile	1	3
	75th Percentile	2	3

P-Value

Outcome: Time in OR Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			0.003
	Mean	41.1	57.1
	Standard Deviation	10.9	18.3

P-Value

Outcome: Analgesia # doses Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			<0.0001
	Median	6	23.5
	25th Percentile	2.8	18
	75th Percentile	10.5	31.5

P-Value

Outcome: Cost Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Burch	Retropubic synthetic	Burch	Comparison Measure	TVT vs. Burch
0 months	N Analyzed	24	25			0.599
	Mean	2231	2125
	Standard Deviation	445.33	569.99

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	Organ injury in OR (urethra, bladder, bowel)	Bladder lesion	Intraop	In-hospital	ND	ND	4	24	RR 4.17 (95% CI 0.5-34.6)	0.19	Comments ( 0 ) \| Post/View
Burch			Intraop	In-hospital	ND	ND	1	25
Total
Retropubic synthetic	Transfusion post-op		Intraop	In-hospital	ND	ND	0	24	ND	NS	Comments ( 0 ) \| Post/View
Burch			Intraop	In-hospital	ND	ND	0	25
Total
Retropubic synthetic	Organ injury in OR (urethra, bladder, bowel)	Urethral injury	Intraop	In-hospital	ND	ND	0	24	ND	NS	Comments ( 0 ) \| Post/View
Burch			Intraop	In-hospital	ND	ND	0	25
Total
Retropubic synthetic	Infection, UTI		Periop	After discharge	ND	ND	1	23	ND	0.49	Comments ( 0 ) \| Post/View
Burch			Periop	After discharge	ND	ND	0	24
Total
Retropubic synthetic		Urinary retention (intervention not defined)	Periop	After discharge	ND	ND	5	23	RR 5.22 (95% CI 0.66-41.33)	1	Comments ( 0 ) \| Post/View
Burch			Periop	After discharge	ND	ND	1	24
Total
Retropubic synthetic	Infection, surgical site/wound		Periop	After discharge	ND	ND	3	23	RR 3.13 (95% CI 0.35-37.96)	0.35	Comments ( 0 ) \| Post/View
Burch			Periop	After discharge	ND	ND	1	24
Total
Retropubic synthetic	De novo urgency		12mo	After discharge	ND	ND	7	23	RR 0.46 (.11-1.84)	0.26	Comments ( 0 ) \| Post/View
Burch			12mo	After discharge	ND	ND	4	24
Total
Retropubic synthetic	De novo urgency		36mo	After discharge	ND	ND	6	21	RR 0.69 (.18-2.73)	0.73	Comments ( 0 ) \| Post/View
Burch			36mo	After discharge	ND	ND	5	23
Total
Retropubic synthetic	Obstruction	(intervention not defined)	12mo	After discharge	ND	ND	4	23	RR 0.21 (.02-2.01)	0.13	Comments ( 0 ) \| Post/View
Burch			12mo	After discharge	ND	ND	1	24
Total
Retropubic synthetic	Obstruction	(intervention not defined)	36mo	After discharge	ND	ND	3	21	RR 0.29 (.03-3.01)	0.35	Comments ( 0 ) \| Post/View
Burch			36mo	After discharge	ND	ND	1	23
Total
Retropubic synthetic	Mesh erosion/extrusion/exposure/granulation tissue	Vaginal - required reoperation	<36mo	After discharge	ND	ND	1	21	ND	ND	Comments ( 0 ) \| Post/View
Burch			<36mo	After discharge	ND	ND	0	23
Total

Select a Topic:
Your Feedback:

Study Preview

A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female stress urinary incontinence.

Exit Disclaimer