Study Preview
Study Title and Description
Complications of mid-urethral slings for treatment of stress urinary incontinence.
Key Questions Addressed
2 | Sling Adverse Events |
Primary Publication Information
Title | Complications of mid-urethral slings for treatment of stress urinary incontinence. |
Author | Pushkar DY., Godunov BN., Gvozdev M., Kasyan GR. |
Country | Moscow State University of Medicine and Dentistry, 127206, Vucheticha 21, Moscow, Russia. |
Year | 2011 |
Numbers |
Pubmed ID: 21315346 2217 (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 | Retropubic synthetic | TVT | |
2 | Transobturator synthetic | TVT-O |
Question... Follow Up | Answer | Follow-up Answer | |
---|---|---|---|
Study Type | Prospective nonrandom (2+ slings analyzed separately) | ||
Study Country ... | Other ... | Russia | |
Sling Category | Retropubic synthetic | ||
Obturator synthetic | |||
Multicenter? | No | ||
Institution Type | Academic hospital | ||
No. of Surgeons Performing the Procedures ... | Other ... | 5 | |
Surgeons' Training | Urology | ||
Residents or Fellows Performing the Surgery? | Unclear/Not reported | ||
Adverse Event Ascertainment | Unclear/Not reported | ||
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 | ||
Comments (overall study) | TVT versus TVT-O |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Retropubic synthetic | hematoma | not defined | 1 month | not stated | no | no | 17 | 187 | |||
Transobturator synthetic | 8 | 537 | |||||||||
Total | 25 | 724 | 0.001 | ||||||||
Retropubic synthetic | Organ injury in OR (urethra, bladder, bowel) | bladder trauma | 1 month | not stated | no | no | 10 | 187 | |||
Transobturator synthetic | 3 | 537 | |||||||||
Total | 13 | 724 | 0.001 | ||||||||
Retropubic synthetic | Pain, other (new or different after surgery) | "postoperative pain" | 1 month | not stated | no | no | 4 | 187 | |||
Transobturator synthetic | 11 | 537 | |||||||||
Total | 15 | 724 | 0.823 | ||||||||
Retropubic synthetic | Organ injury in OR (urethra, bladder, bowel) | vaginal laceration | 1 month | not stated | no | no | 0 | 187 | |||
Transobturator synthetic | 15 | 537 | |||||||||
Total | 15 | 724 | 0.044 | ||||||||
Retropubic synthetic | Mesh erosion/extrusion/exposure/granulation tissue | tape extrusion | 1 month | after discharge | no | no | 1 | 187 | |||
Transobturator synthetic | 8 | 537 | |||||||||
Total | 9 | 724 | 0.420 | ||||||||
Retropubic synthetic | de novo OAB | 1 month | after discharge | no | no | 15 | 187 | ||||
Transobturator synthetic | 26 | 537 | |||||||||
Total | 41 | 724 | 0.151 | ||||||||
Retropubic synthetic | de novo UUI | 1 month | after discharge | no | no | 4 | 187 | ||||
Transobturator synthetic | 8 | 537 | |||||||||
Total | 12 | 724 | 0.790 | ||||||||
Retropubic synthetic | Obstruction requiring reoperation | sling incision | 1 month | after discharge | no | no | 4 | 187 | |||
Transobturator synthetic | 3 | 537 | |||||||||
Total | 7 | 724 | 0.142 | ||||||||
Retropubic synthetic | PVR>100 | 1 month | after discharge | no | no | 11 | 187 | ||||
Transobturator synthetic | 16 | 537 | |||||||||
Total | 27 | 724 | 0.114 |