Study Preview

Study Title and Description

Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension-free vaginal tape for 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

Title	Data
Title	Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension-free vaginal tape for stress urinary incontinence.
Author	Bai SW., Sohn WH., Chung DJ., Park JH., Kim SK.
Country	Department of Obstetrics and Gynecology, Institute of Women's Life Science, Yonsei University, Yonsei University College of Medicine, Seoul, Korea. swbai@yumc.yonsei.ac.kr
Year	2005
Numbers	Pubmed ID: 16242695 535 (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	Burch		Comments ( 0 ) \| Post/View
2	PVS, fascial	autologous rectus muscle fascia	Comments ( 0 ) \| Post/View
3	TVT		Comments ( 0 ) \| Post/View

Design Details
Question... Follow Up	Answer	Follow-up Answer
Country	South Korea		Comments ( 0 ) \| Post/View
Outcome Categories Reported	Objective SUI		Comments ( 0 ) \| Post/View
Outcome Categories Reported	Subjective SUI		Comments ( 0 ) \| Post/View
Population (reason for surgery etc.)	Symptomatic SUI		Comments ( 0 ) \| Post/View
Population (reason for surgery etc.)	Urodynamic SUI		Comments ( 0 ) \| Post/View
RCT Comparison Category ...	Other comparison ...	TVT vs Burch vs PVS	Comments ( 0 ) \| Post/View
Multicenter	No		Comments ( 0 ) \| Post/View
Institution Type ...	Other ...	medical cente	Comments ( 0 ) \| Post/View
Number of surgeons performing procedures	1		Comments ( 0 ) \| Post/View
Surgeons' Training	General		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 ...	unknown	Comments ( 0 ) \| Post/View

Baseline Characteristics

Question	Burch		PVS, fascial		TVT		Total		Comments
Question	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Comments
No. Randomized	33		28		31				Comments ( 0 ) \| Post/View
Mean Age	56.5yr		56.3yr		58.2				Comments ( 0 ) \| Post/View
Post-Op Follow-Up Interval (Maximum)	1yr		1yr		1yr				Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value

Outcome: SUI cure Population: All Participants					Between-Arm Comparisons
Time Point	Measure	Burch	PVS, fascial	TVT	Comparison Measure	Burch vs. PVS, fascial
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	33	28	31
	Counts	31 N	27 N	29 N
	Standard Deviation
					p<.05, favors PVS

Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation

Outcome: De novo DO Population: All Participants					Between-Arm Comparisons
Time Point	Measure	Burch	PVS, fascial	TVT	Comparison Measure	Burch vs. PVS, fascial
1 years	N Enrolled	33	28	31
	Counts	3	0	0
	Standard Deviation
					not given
0 years	N Enrolled
	Counts
	Standard Deviation

Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value

Outcome: Urinary retention Population: All Participants					Between-Arm Comparisons
Time Point	Measure	Burch	PVS, fascial	TVT	Comparison Measure	Burch vs. PVS, fascial
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	33	28	31
	Counts	0	2	4
	Standard Deviation
					not given

Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation

Outcome: Urinary hesitancy Population: All Participants					Between-Arm Comparisons
Time Point	Measure	Burch	PVS, fascial	TVT	Comparison Measure	Burch vs. PVS, fascial
1 years	N Enrolled	33	28	31
	Counts	1	0	0
	Standard Deviation
					not given
0 years	N Enrolled
	Counts
	Standard Deviation

Extraction Form: Sling Adverse Events

Arms

No arms have been defined in this extraction form.

Design Details
Question... Follow Up	Answer
Study Type	RCT	Comments ( 0 ) \| Post/View
Study Country	South Korea	Comments ( 0 ) \| Post/View
Sling Category	Retropubic synthetic	Comments ( 0 ) \| Post/View
Sling Category	Pubovaginal (bladder neck)	Comments ( 0 ) \| Post/View
Multicenter?	No	Comments ( 0 ) \| Post/View
Institution Type	Community hospital	Comments ( 0 ) \| Post/View
No. of Surgeons Performing the Procedures	1	Comments ( 0 ) \| Post/View
Surgeons' Training	General	Comments ( 0 ) \| Post/View
Residents or Fellows Performing the Surgery?	No	Comments ( 0 ) \| Post/View
Adverse Event Ascertainment	Unclear/Not reported	Comments ( 0 ) \| Post/View
Was a data safety monitoring board used?	No / Not reported	Comments ( 0 ) \| Post/View
Study Sponsor/Funding ...	Other ...	Comments ( 0 ) \| Post/View
Comments (overall study)	No AEs reported	Comments ( 0 ) \| Post/View

Results & Comparisons

Results Data

Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value

Outcome: SUI cure Population: All Participants					Between-Arm Comparisons
Time Point	Measure	Burch	PVS, fascial	TVT	Comparison Measure	Burch vs. PVS, fascial
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	33	28	31
	Counts	31 N	27 N	29 N
	Standard Deviation
					p<.05, favors PVS

Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation

Outcome: De novo DO Population: All Participants					Between-Arm Comparisons
Time Point	Measure	Burch	PVS, fascial	TVT	Comparison Measure	Burch vs. PVS, fascial
1 years	N Enrolled	33	28	31
	Counts	3	0	0
	Standard Deviation
					not given
0 years	N Enrolled
	Counts
	Standard Deviation

Statistical Test: Odds Ratio (OR) Standard Deviation Statistical Test: Odds Ratio (OR) Standard Deviation P-Value

Outcome: Urinary retention Population: All Participants					Between-Arm Comparisons
Time Point	Measure	Burch	PVS, fascial	TVT	Comparison Measure	Burch vs. PVS, fascial
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	33	28	31
	Counts	0	2	4
	Standard Deviation
					not given

Statistical Test: Odds Ratio (OR) Standard Deviation P-Value Statistical Test: Odds Ratio (OR) Standard Deviation

Outcome: Urinary hesitancy Population: All Participants					Between-Arm Comparisons
Time Point	Measure	Burch	PVS, fascial	TVT	Comparison Measure	Burch vs. PVS, fascial
1 years	N Enrolled	33	28	31
	Counts	1	0	0
	Standard Deviation
					not given
0 years	N Enrolled
	Counts
	Standard Deviation

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
Total	None reported										Comments ( 0 ) \| Post/View