Study Preview
Study Title and Description
Short-term assessment of a tension-free vaginal tape for treating female stress urinary incontinence.
Key Questions Addressed
2 | Sling Adverse Events |
Primary Publication Information
Title | Short-term assessment of a tension-free vaginal tape for treating female stress urinary incontinence. |
Author | Oliveira R., Silva A., Pinto R., Silva J., Silva C., Guimarães M., Dinis P., Cruz F. |
Country | Hospital de São João, Serviço de Urologia, Porto, Portugal. |
Year | 2009 |
Numbers |
Pubmed ID: 19154506 51 (internal) |
Secondary Publication Information
There are currently no secondary publications defined for this study.
Extraction Form: Sling Adverse Events
Arms
Number | Title | Description | Comments |
---|---|---|---|
1 | Minisling obturator | TVT secur in H position in all 107 patients |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Study Type | Retrospective Cohort (all received same sling) | ||
Study Country ... | Other ... | Portugal | |
Sling Category | Minisling H (obturator) | ||
Multicenter? | No | ||
Institution Type | Academic hospital | ||
No. of Surgeons Performing the Procedures | Unclear/Not reported | ||
Surgeons' Training | Urology | ||
Residents or Fellows Performing the Surgery? | Unclear/Not reported | ||
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 | Not reported |
Results & Comparisons
No Results found.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Minisling obturator | Mesh erosion/extrusion/exposure/granulation tissue | Major in 1 an dminor in 5 | up to 15 months | after | ? | None | 6 | 106 | |||
Total | |||||||||||
Minisling obturator | Pain, groin (new or different after surgery) | up to 15 months | after | ? | None | 0 | 106 | ||||
Total | |||||||||||
Minisling obturator | Return to OR | 1 urthrolysis for mesh erosion | up to 15 months | after | ? | None | 1 | 106 | |||
Total | |||||||||||
Minisling obturator | Organ injury in OR (urethra, bladder, bowel) | In | in | ? | None | 0 | 107 | ||||
Total | |||||||||||
Minisling obturator | Pain, groin (new or different after surgery) | up to 15 months | after | ? | None | 0 | 106 | ||||
Total | |||||||||||
Minisling obturator | de novo urge | up to 15 months | after | ? | None | 6 | 106 | ||||
Total |