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Study Title and Description

Prospective randomized trial of TVT and TOT as primary treatment for female stress urinary incontinence with or without pelvic organ prolapse in Southeast China.



Key Questions Addressed
1 Sling vs Comparator RCT outcomes (excluding AEs)
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2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Prospective randomized trial of TVT and TOT as primary treatment for female stress urinary incontinence with or without pelvic organ prolapse in Southeast China.
Author Wang F., Song Y., Huang H.
Country Department of Obstetrics and Gynecology, Fuzhou General Hospital, 350025, Fuzhou, Fujian, China.
Year 2010
Numbers Pubmed ID: 19404656
560 (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
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2 TOT_out-to-in
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Design Details
Question... Follow Up Answer Follow-up Answer
Country China
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Outcome Categories Reported Objective SUI
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Subjective SUI
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Quality of life
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OR outcomes/complications (not "AEs")
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Population (reason for surgery etc.) Symptomatic SUI
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Urodynamic SUI
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Recurrent incontinence after surgery
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Concomitant prolapse surgery
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RCT Comparison Category Retropubic vs. Obturator
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Multicenter No
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Institution Type Unclear/Not reported
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Number of surgeons performing procedures 1
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Surgeons' Training ... Other ... Gynecology
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Residents or fellows performing surgery? Unclear/Not reported
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Study Quality (overall) A (good)
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Study Sponsor/Funding ... Other ... Unclear
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Baseline Characteristics
Question TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
No. Randomized No data entered.
Mean Age No data entered.
Post-Op Follow-Up Interval (Maximum) No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Negative pad test--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


12 months

N Enrolled 40 48 0.852
Counts 38 46
P-Value
Outcome: Negative pad test--concom surg      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


12 months

N Enrolled 30 22 0.400
Counts 28 19
P-Value
Outcome: Neg cough stress test--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


12 months

N Enrolled 40 48 0.801
Counts 38 45
P-Value
Outcome: Neg cough stress test--concom surg      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


12 months

N Enrolled 30 22 0.685
Counts 27 19
P-Value
Outcome: Catheter time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 34 32 0.356
Max 72 72
Min 12 12
N Analyzed 70 70
P-Value
Outcome: Catheter time      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 18 16 0.567
Max 24 24
Min 12 12
P-Value
Outcome: Catheter time      Population: Concom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 28 30 0.348
Max 72 72
Min 24 24
P-Value P-Value
Outcome: UDI-6      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 49 46 >0.05
N Analyzed 70 70
Standard Deviation 21 20


12 months

Mean 15 14 >0.05
N Analyzed 70 70
Standard Deviation 15 17
P-Value P-Value
Outcome: UDI-6      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 52 50 >0.05
Standard Deviation 18 17


12 months

Mean 18 19 >0.05
Standard Deviation 12 12
P-Value P-Value
Outcome: UDI-6      Population: Conom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 45 45 >0.05
Standard Deviation 25 21


12 months

Mean 16 14 >0.05
Standard Deviation 14 15
P-Value P-Value
Outcome: IIQ-7      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 40 42 >0.05
Standard Deviation 21 20
N Analyzed 70 70


12 months

Mean 13 10 >0.05
Standard Deviation 12 12
N Analyzed 70 70
P-Value P-Value
Outcome: IIQ-7      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 45 41 >0.05
Standard Deviation 23 31


12 months

Mean 8 9 >0.05
Standard Deviation 12 11
P-Value P-Value
Outcome: IIQ-7      Population: Concom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 40 45 >0.05
Standard Deviation 27 21


12 months

Mean 12 11 >0.05
Standard Deviation 14 15
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

N Analyzed 70 70 0.082
Mean 35.5 29.8
Max 80 80
Min 18 10
P-Value
Outcome: Time in OR      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 21 12 0.012
Max 30 21
Min 18 10
P-Value
Outcome: Time in OR      Population: Concom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 62 65 0.324
Max 80 75
Min 35 30
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 3.6 3.2 0.708
Max 6 5
Min 1 1
N Analyzed 70 70
P-Value
Outcome: Time in hospital      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 1.4 1.5 0.712
Max 3 3
Min 1 1
P-Value
Outcome: Time in hospital      Population: Concom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 4.3 3.9 0.612
Max 6 5
Min 3 3


Extraction Form: Sling Adverse Events
Arms
Number Title Description Comments
1 Retropubic synthetic
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2 Transobturator synthetic
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type RCT
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Sling Category Retropubic synthetic
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Obturator synthetic
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Adverse Event Ascertainment Unclear/Not reported
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Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding Not reported
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Results & Comparisons


Results Data
P-Value
Outcome: Negative pad test--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


12 months

N Enrolled 40 48 0.852
Counts 38 46
P-Value
Outcome: Negative pad test--concom surg      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


12 months

N Enrolled 30 22 0.400
Counts 28 19
P-Value
Outcome: Neg cough stress test--sling only      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


12 months

N Enrolled 40 48 0.801
Counts 38 45
P-Value
Outcome: Neg cough stress test--concom surg      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


12 months

N Enrolled 30 22 0.685
Counts 27 19
P-Value
Outcome: Catheter time      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 34 32 0.356
Max 72 72
Min 12 12
N Analyzed 70 70
P-Value
Outcome: Catheter time      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 18 16 0.567
Max 24 24
Min 12 12
P-Value
Outcome: Catheter time      Population: Concom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 28 30 0.348
Max 72 72
Min 24 24
P-Value P-Value
Outcome: UDI-6      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 49 46 >0.05
N Analyzed 70 70
Standard Deviation 21 20


12 months

Mean 15 14 >0.05
N Analyzed 70 70
Standard Deviation 15 17
P-Value P-Value
Outcome: UDI-6      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 52 50 >0.05
Standard Deviation 18 17


12 months

Mean 18 19 >0.05
Standard Deviation 12 12
P-Value P-Value
Outcome: UDI-6      Population: Conom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 45 45 >0.05
Standard Deviation 25 21


12 months

Mean 16 14 >0.05
Standard Deviation 14 15
P-Value P-Value
Outcome: IIQ-7      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 40 42 >0.05
Standard Deviation 21 20
N Analyzed 70 70


12 months

Mean 13 10 >0.05
Standard Deviation 12 12
N Analyzed 70 70
P-Value P-Value
Outcome: IIQ-7      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 45 41 >0.05
Standard Deviation 23 31


12 months

Mean 8 9 >0.05
Standard Deviation 12 11
P-Value P-Value
Outcome: IIQ-7      Population: Concom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 40 45 >0.05
Standard Deviation 27 21


12 months

Mean 12 11 >0.05
Standard Deviation 14 15
P-Value
Outcome: Time in OR      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

N Analyzed 70 70 0.082
Mean 35.5 29.8
Max 80 80
Min 18 10
P-Value
Outcome: Time in OR      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 21 12 0.012
Max 30 21
Min 18 10
P-Value
Outcome: Time in OR      Population: Concom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 62 65 0.324
Max 80 75
Min 35 30
P-Value
Outcome: Time in hospital      Population: All Participants Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 3.6 3.2 0.708
Max 6 5
Min 1 1
N Analyzed 70 70
P-Value
Outcome: Time in hospital      Population: Sling only Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 1.4 1.5 0.712
Max 3 3
Min 1 1
P-Value
Outcome: Time in hospital      Population: Concom surgery Between-Arm Comparisons
Time Point Measure TVT TOT_out-to-in Retropubic synthetic Transobturator synthetic Comparison Measure TVT vs. TOT_out-to-in


0 months

Mean 4.3 3.9 0.612
Max 6 5
Min 3 3

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 perforation Intra-op In-hospital No ND 3 70 ND 0.310
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Transobturator synthetic Intra-op In-hospital No ND 1 70 ND
Total
Retropubic synthetic Nerve injury Intra-op In-hospital No ND 0 70 ND NA
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Transobturator synthetic Intra-op In-hospital No ND 0 70 ND
Total
Retropubic synthetic Vessel injury/ hemorrhage Intra-op In-hospital No ND 0 70 ND NA
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Transobturator synthetic Intra-op In-hospital No ND 0 70 ND
Total
Retropubic synthetic Infection, other Unclear After discharge No ND 0 70 ND NA
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Transobturator synthetic Unclear After discharge No ND 0 70 ND
Total
Retropubic synthetic Organ injury in OR (urethra, bladder, bowel) Urethra or bowel Intra-op In-hospital No ND 0 70 ND NA
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Transobturator synthetic Intra-op In-hospital No ND 0 70 ND
Total
Retropubic synthetic Pain, groin (new or different after surgery) Thigh or buttock discomfort <1mo After discharge No ND 3 70 ND 0.116
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Transobturator synthetic <1mo After discharge No ND 8 70 ND
Total
Retropubic synthetic Voiding dysfunction Short-term difficulty <1mo After discharge No ND 8 70 ND 0.317
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Transobturator synthetic <1mo After discharge No ND 6 70 ND
Total
Retropubic synthetic Mesh erosion/extrusion/exposure/granulation tissue Vaginal <3mo After discharge No ND 1 70 ND 0.559
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Transobturator synthetic <3mo After discharge No ND 2 70 ND
Total
Retropubic synthetic Tape division Indication not given or timing Unclear Unclear No ND 0 70 ND ND
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Transobturator synthetic Unclear Unclear No ND 1 70 ND
Total
Retropubic synthetic De novo urgency Unclear After discharge No ND 3 70 ND 1.320
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Transobturator synthetic Unclear After discharge No ND 1 70 ND
Total
Retropubic synthetic De novo frequency Unclear After discharge No ND 4 70 ND 0.698
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Transobturator synthetic Unclear After discharge No ND 3 70 ND
Total
Retropubic synthetic Overactive bladder Unclear After discharge No ND 1 70 ND 0.172
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Transobturator synthetic Unclear After discharge No ND 4 70 ND
Total