Study Preview
Study Title and Description
Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence.
Key Questions Addressed
1 | Sling vs Comparator RCT outcomes (excluding AEs) | |
2 | Sling Adverse Events |
Primary Publication Information
Title | Tension-free vaginal tape versus tension-free vaginal tape obturator in women with stress urinary incontinence. |
Author | Liapis A., Bakas P., Giner M., Creatsas G. |
Country | 2nd Department of Obstetrics and Gynecology, Aretaieio Hospital, University of Athens, Athens, Greece. |
Year | 2006 |
Numbers |
Pubmed ID: 16707901 397 (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 | ||
2 | TVT-O |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Country | Greece | ||
Outcome Categories Reported | Objective SUI | ||
Subjective SUI | |||
Population (reason for surgery etc.) | Symptomatic SUI | ||
Urodynamic SUI | |||
RCT Comparison Category | Retropubic vs. Obturator | ||
Multicenter | No | ||
Institution Type | Academic hospital | ||
Number of surgeons performing procedures | 1 | ||
Surgeons' Training | Not reported | ||
Residents or fellows performing surgery? | Unclear/Not reported | ||
Study Quality (overall) | C (poor) | ||
Study Sponsor/Funding ... | Other ... | unknown |
Baseline Characteristics
Question | TVT | TVT-O | TVT | TVT-O | Total | Comments | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
No. Randomized | 46 | 43 | |||||||||
Mean Age | 53 | 52 | |||||||||
Post-Op Follow-Up Interval (Maximum) | 1yr | 1yr |
Results & Comparisons
Results Data
Outcome: SUI objective- Cure Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation | |||||||
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 89% | 90% | |||||
Standard Deviation | |||||||
NS |
Outcome: SUI objective â€“ IMPROVED Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 6.5% | 7.6% | |||||
Standard Deviation | |||||||
NS | |||||||
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: SUI objective - FAILURE Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation | |||||||
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 4.3% | 2.5% | |||||
Standard Deviation | |||||||
NS |
Outcome: SUI subjective cure Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 34 N | 43 N | |||||
Standard Deviation | |||||||
NS | |||||||
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: SUI subjective improvement Population: All Participants | Between-Arm Comparisons | |||||
---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure |
0 years |
N Enrolled | |||||
Counts | ||||||
Standard Deviation | ||||||
1 years |
N Enrolled | |||||
Counts | ||||||
Standard Deviation | ||||||
Outcome: SUI subjective failure Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 2 N | 3 N | |||||
Standard Deviation | |||||||
NS | |||||||
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: Time in hospital 1d Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | 46 | 43 | ||||
Counts | 42 | 41 | |||||
Standard Deviation | |||||||
NS | |||||||
1 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: Time in hospital 2d Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation | |||||||
0 years |
N Enrolled | 46 | 43 | ||||
Counts | 3 | 2 | |||||
Standard Deviation | |||||||
NS |
Outcome: Time in hospital >3d Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | 46 | 43 | ||||
Counts | 1 | 0 | |||||
Standard Deviation | |||||||
NS | |||||||
1 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: Post op Detrusor instability Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 8.6% | 9.3% | |||||
Standard Deviation | |||||||
not given | |||||||
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: De novo urgency Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | 46 | 43 | ||||
Counts | 10.8% | 13.9% | |||||
Standard Deviation | |||||||
not given | |||||||
1 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: EBL Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Analyzed | ||||||
Mean | |||||||
Standard Deviation | |||||||
0 years |
N Analyzed | 46 | 43 | ||||
Mean | 1.0 | .9 | |||||
Standard Deviation | |||||||
NS |
Outcome: Time in OR Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Analyzed | 46 | 43 | ||||
Mean | 26.7min | 17.4min | |||||
Standard Deviation | |||||||
<.001 | |||||||
1 years |
N Analyzed | ||||||
Mean | |||||||
Standard Deviation |
Extraction Form: Sling Adverse Events
Arms
Number | Title | Description | Comments |
---|---|---|---|
1 | TVT | ||
2 | TVT-O |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Study Type | RCT | ||
Study Country | Greece | ||
Sling Category ... | Other ... | retropubic synthetic and transobturator synthetic | |
Multicenter? | No | ||
Institution Type | Academic hospital | ||
No. of Surgeons Performing the Procedures | 1 | ||
Surgeons' Training | Not reported | ||
Residents or Fellows Performing the Surgery? | Unclear/Not reported | ||
Adverse Event Ascertainment | Passive | ||
Was the Clavien-Dindo Classification of Surgical Complications system used? | No / Not reported | ||
Was a data safety monitoring board used? | No / Not reported | ||
Study Sponsor/Funding | Not reported |
Results & Comparisons
Results Data
Outcome: SUI objective- Cure Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation | |||||||
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 89% | 90% | |||||
Standard Deviation | |||||||
NS |
Outcome: SUI objective â€“ IMPROVED Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 6.5% | 7.6% | |||||
Standard Deviation | |||||||
NS | |||||||
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: SUI objective - FAILURE Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation | |||||||
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 4.3% | 2.5% | |||||
Standard Deviation | |||||||
NS |
Outcome: SUI subjective cure Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 34 N | 43 N | |||||
Standard Deviation | |||||||
NS | |||||||
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: SUI subjective improvement Population: All Participants | Between-Arm Comparisons | |||||
---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure |
0 years |
N Enrolled | |||||
Counts | ||||||
Standard Deviation | ||||||
1 years |
N Enrolled | |||||
Counts | ||||||
Standard Deviation | ||||||
Outcome: SUI subjective failure Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 2 N | 3 N | |||||
Standard Deviation | |||||||
NS | |||||||
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: Time in hospital 1d Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | 46 | 43 | ||||
Counts | 42 | 41 | |||||
Standard Deviation | |||||||
NS | |||||||
1 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: Time in hospital 2d Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation | |||||||
0 years |
N Enrolled | 46 | 43 | ||||
Counts | 3 | 2 | |||||
Standard Deviation | |||||||
NS |
Outcome: Time in hospital >3d Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | 46 | 43 | ||||
Counts | 1 | 0 | |||||
Standard Deviation | |||||||
NS | |||||||
1 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: Post op Detrusor instability Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Enrolled | 46 | 43 | ||||
Counts | 8.6% | 9.3% | |||||
Standard Deviation | |||||||
not given | |||||||
0 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: De novo urgency Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Enrolled | 46 | 43 | ||||
Counts | 10.8% | 13.9% | |||||
Standard Deviation | |||||||
not given | |||||||
1 years |
N Enrolled | ||||||
Counts | |||||||
Standard Deviation |
Outcome: EBL Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
1 years |
N Analyzed | ||||||
Mean | |||||||
Standard Deviation | |||||||
0 years |
N Analyzed | 46 | 43 | ||||
Mean | 1.0 | .9 | |||||
Standard Deviation | |||||||
NS |
Outcome: Time in OR Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | TVT | TVT-O | TVT | TVT-O | Comparison Measure | TVT vs. TVT-O |
0 years |
N Analyzed | 46 | 43 | ||||
Mean | 26.7min | 17.4min | |||||
Standard Deviation | |||||||
<.001 | |||||||
1 years |
N Analyzed | ||||||
Mean | |||||||
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 |
---|---|---|---|---|---|---|---|---|---|---|---|
TVT | Vaginal erosion (required excision of tape) | 1 | 46 | --- | |||||||
TVT-O | 0 | 43 | |||||||||
Total | |||||||||||
TVT | Organ injury in OR (urethra, bladder, bowel) | bladder perforation | 3 | 46 | --- | ||||||
TVT-O | 0 | 43 | |||||||||
Total | |||||||||||
TVT | Retention requiring catheter | Cath x 10 days | 1 | 46 | --- | ||||||
TVT-O | 0 | 43 | |||||||||
Total | |||||||||||
TVT | hemtoma | space of Reitzius | 0 | 46 | |||||||
TVT-O | 0 | 43 | |||||||||
Total | |||||||||||
TVT | Retention >100 mL | 4 | 46 | ||||||||
TVT-O | 0 | 43 | |||||||||
Total | |||||||||||
TVT | Req vag pack x 24 hr | 1 | 46 | ||||||||
TVT-O | 0 | 43 | |||||||||
Total | |||||||||||
TVT | |||||||||||
TVT-O | |||||||||||
Total |