Study Preview
Study Title and Description
The multifilament polypropylene tape erosion trouble: tape structure vs surgical technique. Which one is the cause?
Key Questions Addressed
1 | Sling vs Comparator RCT outcomes (excluding AEs) | |
2 | Sling Adverse Events |
Primary Publication Information
Title | The multifilament polypropylene tape erosion trouble: tape structure vs surgical technique. Which one is the cause? |
Author | Sivaslioglu AA, Unlubilgin E, Dölen I |
Country | -- |
Year | 2008 |
Numbers |
Pubmed ID: 17876489 2353 (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 | IVS | Loose tensioning | |
2 | IVS | Tape touching urethra, covered with fascia |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Country ... | Other ... | Turkey | |
Outcome Categories Reported | Objective SUI | ||
OR outcomes/complications (not "AEs") | |||
Population (reason for surgery etc.) | Symptomatic SUI | ||
Urodynamic SUI | |||
RCT Comparison Category | Retropubic vs. Other | ||
Other comparison ... | Retropubic sling (IVS tunneller vs itself with 2 tesnioning techniques) | ||
Multicenter | No | ||
Institution Type | Academic hospital | ||
Number of surgeons performing procedures | 1 | ||
Surgeons' Training | Urogynecology | ||
Residents or fellows performing surgery? | No | ||
Study Quality (overall) | C (poor) | ||
Study Sponsor/Funding | Industry |
Baseline Characteristics
Question | IVS | IVS | IVS tunneler - LOOSE | IVS tunneler - SNUG | Total | Comments | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | Answer | Follow-up | ||
No. Randomized | 50 | 57 | |||||||||
Mean Age | 48 | 46 | |||||||||
Post-Op Follow-Up Interval (Maximum) | 44 mo | 44 mo |
Results & Comparisons
Results Data
Outcome: Negative cough stress test Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | IVS | IVS | IVS tunneler - LOOSE | IVS tunneler - SNUG | Comparison Measure | IVS vs. IVS |
44 months |
N Analyzed | 44 | 54 | 0.66 | |||
Percentage | 87% | 88% |
Outcome: De novo urgency UI Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | IVS | IVS | IVS tunneler - LOOSE | IVS tunneler - SNUG | Comparison Measure | IVS vs. IVS |
44 months |
Counts | 2 | 7 | 0.03 | |||
N Analyzed | 44 | 54 | |||||
Percentage | 4.5% | 12.9% |
Extraction Form: Sling Adverse Events
Arms
Number | Title | Description | Comments |
---|---|---|---|
1 | IVS tunneler - LOOSE | ||
2 | IVS tunneler - SNUG |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Study Type | RCT | ||
Study Country ... | Other ... | Turkey | |
Sling Category | Retropubic synthetic | ||
Adverse Event Ascertainment | Active | ||
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 | Industry |
Results & Comparisons
Results Data
Outcome: Negative cough stress test Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | IVS | IVS | IVS tunneler - LOOSE | IVS tunneler - SNUG | Comparison Measure | IVS vs. IVS |
44 months |
N Analyzed | 44 | 54 | 0.66 | |||
Percentage | 87% | 88% |
Outcome: De novo urgency UI Population: All Participants | Between-Arm Comparisons | ||||||
---|---|---|---|---|---|---|---|
Time Point | Measure | IVS | IVS | IVS tunneler - LOOSE | IVS tunneler - SNUG | Comparison Measure | IVS vs. IVS |
44 months |
Counts | 2 | 7 | 0.03 | |||
N Analyzed | 44 | 54 | |||||
Percentage | 4.5% | 12.9% |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|
IVS tunneler - LOOSE | Mesh erosion/extrusion/exposure/granulation tissue | 44 mo | After-discharge | ND | ND | 6 | 44 | ND | 0.04 | ||
IVS tunneler - SNUG | 44 mo | After-discharge | ND | ND | 1 | 54 | ND | ||||
Total | |||||||||||
IVS tunneler - LOOSE | De novo urgency | 44 mo | After-discharge | ND | ND | 2 | 44 | ND | 0.03 | ||
IVS tunneler - SNUG | 44 mo | After-discharge | ND | ND | 7 | 54 | |||||
Total | |||||||||||
IVS tunneler - LOOSE | Retention requiring surgery | Vaginal urethrolysis | Unclear | After-discharge | ND | ND | 0 | 44 | ND | 0.74 | |
IVS tunneler - SNUG | 2 wk | After-discharge | ND | ND | 1 | 54 | ND | ||||
Total |