Study Preview

Study Title and Description

A randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult 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 randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult stress urinary incontinence.
Author	Meschia M., Pifarotti P., Spennacchio M., Buonaguidi A., Gattei U., Somigliana E.
Country	Department of Obstetrics and Gynecology, Urogynecology Unit, University of Milan, Milano, Italy. m.meschia@libero.it
Year	2004
Numbers	Pubmed ID: 15041988 8303 (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	TVT performed by Ulmsten. The TVT procedure was peformed using Gynecare TVT. Midurethral placement. Small sagittal vaginal incision. This was done PRIOR to repaire of the prolapse. Tape adjusted AFTER prolapse repair. Patient was awakened to cough with a 300cc bladder fill.	Comments ( 0 ) \| Post/View
2	Endopelvic fascial plication	Endopelvic fascia plication was performed at the level of the urethrovesical jnction and was carried out with the use of 2-0 permanent braided polyester sutures.	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
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.)	Other ...	Also, occult SUI revealed with reduction bladder fill	Comments ( 0 ) \| Post/View
RCT Comparison Category	Retropubic vs. Other		Comments ( 0 ) \| Post/View
RCT Comparison Category	Other comparison ...	TVT vs. fascia plication	Comments ( 0 ) \| Post/View
Multicenter	No		Comments ( 0 ) \| Post/View
Institution Type	Academic hospital		Comments ( 0 ) \| Post/View
Number of surgeons performing procedures	Not reported		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 ...	not clear	Comments ( 0 ) \| Post/View

Baseline Characteristics

Question	TVT		Endopelvic fascial plication		Retropubic synthetic		Endopelvic fascial plication		Total		Comments
Question	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Answer	Follow-up	Comments
No. Randomized	25		25						50		Comments ( 0 ) \| Post/View
Mean Age									65yr		Comments ( 0 ) \| Post/View
Post-Op Follow-Up Interval (Maximum)	12mo		12mo								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 objective-Positive cough stress Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	25	25
	Counts	2	11
	Standard Deviation
						<.01

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

Outcome: SUI subjective Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
1 years	N Enrolled	25	25
	Counts	1	9
	Standard Deviation
						.01
0 years	N Enrolled
	Counts
	Standard Deviation

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

Outcome: De novo UUI Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	25	25
	Counts	3	1
	Standard Deviation
						NS

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

Outcome: Retreatment for SUI Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	25	25
	Counts	0	3
	Standard Deviation
						---

N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value

Outcome: EBL Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
1 years	N Analyzed
	Mean
	Standard Deviation
0 years	N Analyzed	25	25
	Mean	188	177
	Standard Deviation
						NS

N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation

Outcome: Time in OR Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
0 years	N Analyzed	25	25
	Mean	131	112
	Standard Deviation
						<.001
1 years	N Analyzed
	Mean
	Standard Deviation

N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value

Outcome: Time in hospital Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
1 years	N Analyzed
	Mean
	Standard Deviation
0 years	N Analyzed	25	25
	Mean	6.4d	6.1d
	Standard Deviation
						NS

N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value

Outcome: drop in Hgb Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure
1 years	N Analyzed
	Mean
	Standard Deviation
0 years	N Analyzed	25	25
	Mean	1.8cc	1cc
	Standard Deviation

Extraction Form: Sling Adverse Events

Arms

Number	Title	Description	Comments
1	Retropubic synthetic	TVT	Comments ( 0 ) \| Post/View
2	Endopelvic fascial plication	Endopelvic fascia plication was performed at the level of the urethrovesical jnction and was carried out with the use of 2-0 permanent braided polyester sutures.	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
Multicenter?	No	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	General	Comments ( 0 ) \| Post/View
Residents or Fellows Performing the Surgery?	Unclear/Not reported	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

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

Outcome: SUI objective-Positive cough stress Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	25	25
	Counts	2	11
	Standard Deviation
						<.01

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

Outcome: SUI subjective Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
1 years	N Enrolled	25	25
	Counts	1	9
	Standard Deviation
						.01
0 years	N Enrolled
	Counts
	Standard Deviation

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

Outcome: De novo UUI Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	25	25
	Counts	3	1
	Standard Deviation
						NS

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

Outcome: Retreatment for SUI Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
0 years	N Enrolled
	Counts
	Standard Deviation
1 years	N Enrolled	25	25
	Counts	0	3
	Standard Deviation
						---

N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value

Outcome: EBL Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
1 years	N Analyzed
	Mean
	Standard Deviation
0 years	N Analyzed	25	25
	Mean	188	177
	Standard Deviation
						NS

N Enrolled Mean Difference Standard Deviation P-Value N Enrolled Mean Difference Standard Deviation

Outcome: Time in OR Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
0 years	N Analyzed	25	25
	Mean	131	112
	Standard Deviation
						<.001
1 years	N Analyzed
	Mean
	Standard Deviation

N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value

Outcome: Time in hospital Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure	TVT vs. Endopelvic fascial plication
1 years	N Analyzed
	Mean
	Standard Deviation
0 years	N Analyzed	25	25
	Mean	6.4d	6.1d
	Standard Deviation
						NS

N Enrolled Mean Difference Standard Deviation N Enrolled Mean Difference Standard Deviation P-Value

Outcome: drop in Hgb Population: All Participants						Between-Arm Comparisons
Time Point	Measure	TVT	Endopelvic fascial plication	Retropubic synthetic	Endopelvic fascial plication	Comparison Measure
1 years	N Analyzed
	Mean
	Standard Deviation
0 years	N Analyzed	25	25
	Mean	1.8cc	1cc
	Standard Deviation

Adverse Events

Arm or Total	Title	Description	Follow-up time	In-hospital or After discharge	Number affected	Number at risk (analyzed)	Comments
Retropubic synthetic	Infection, UTI	unclear	post op	after discharge	3	25	Comments ( 0 ) \| Post/View
Endopelvic fascial plication					1	25
Total
Retropubic synthetic	Retention requiring catheter	delayed voiding			2	25	Comments ( 0 ) \| Post/View
Endopelvic fascial plication					2	25
Total
Retropubic synthetic	Bladder perforation						Comments ( 0 ) \| Post/View
Endopelvic fascial plication					1	25
Total

Select a Topic:
Your Feedback:

Study Preview

A randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult stress urinary incontinence.

Exit Disclaimer