This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



Study Title and Description

Transobturator vs single-incision suburethral mini-slings for treatment of female stress urinary incontinence: early postoperative pain and 3-year follow-up



Key Questions Addressed
2 Sling Adverse Events
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Transobturator vs single-incision suburethral mini-slings for treatment of female stress urinary incontinence: early postoperative pain and 3-year follow-up
Author Neuman M, Sosnovski V, Kais M, Ophir E, Bornstein J.
Country Department of Obstetrics and Gynecology, Western Galilee Hospital, Nahariya, Israel. mneuman@netvision.net.il
Year 2011
Numbers Pubmed ID: 22024263
1034 (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 Transobturator synthetic TVT-O
  • Comments Comments (
    0
    ) |
2 Minisling obturator TVT-SECUR
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Prospective nonrandom (2+ slings analyzed separately)
  • Comments Comments (
    0
    ) |
Study Name Three-Year Follow-up of Urethral Sling Operations
  • Comments Comments (
    0
    ) |
Study Country ... Other ... Israel
  • Comments Comments (
    0
    ) |
Sling Category Obturator synthetic
  • Comments Comments (
    0
    ) |
Minisling H (obturator)
  • Comments Comments (
    0
    ) |
Multicenter? No
  • Comments Comments (
    0
    ) |
Institution Type Academic hospital
  • Comments Comments (
    0
    ) |
Community hospital
  • Comments Comments (
    0
    ) |
No. of Surgeons Performing the Procedures 1
  • Comments Comments (
    0
    ) |
Surgeons' Training Not reported
  • Comments Comments (
    0
    ) |
Residents or Fellows Performing the Surgery? Unclear/Not reported
  • Comments Comments (
    0
    ) |
Adverse Event Ascertainment Active
  • Comments Comments (
    0
    ) |
Passive
  • Comments Comments (
    0
    ) |
Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
  • Comments Comments (
    0
    ) |
Was a data safety monitoring board used? No / Not reported
  • Comments Comments (
    0
    ) |
Study Sponsor/Funding ... Other ... Funding not reported. Of note, paper specifically states that the authors have no financial disclosures, but 2008 Neuman paper stated that Neuman was a TVT-Secur trainer for Ethicon
  • Comments Comments (
    0
    ) |
Comments (overall study) Study did list most relevant AEs; was not clear how all were assessed and follow up time for AEs was not clear. Subjects had not been included in previous publications. Patients were informed about both techniques, and the patient allowed to choose which arm they would be enrolled in.
  • Comments Comments (
    0
    ) |




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
Transobturator synthetic Organ injury in OR (urethra, bladder, bowel) in OR in hospital not listed not listed 0 73 not listed n/a
  • Comments Comments (
    0
    ) |
Minisling obturator 0 79
Total
Transobturator synthetic EBL >100cc in OR in hospital not listed not listed 0 73 not listed 4.80
  • Comments Comments (
    0
    ) |
Minisling obturator 1 79
Total
Transobturator synthetic Mesh erosion/extrusion/exposure/granulation tissue not further defined not listed not listed not listed not listed 1 73 not listed 1.00
  • Comments Comments (
    0
    ) |
Minisling obturator 0 79
Total
Transobturator synthetic Infection, surgical site/wound not further defined not listed not listed not listed not listed 0 73 not listed n/a
  • Comments Comments (
    0
    ) |
Minisling obturator 0 79
Total
Transobturator synthetic "early voiding difficulty" not further defined not listed not listed not listed not listed 4 73 not listed 0.15
  • Comments Comments (
    0
    ) |
Minisling obturator 9 79
Total
Transobturator synthetic Infection, UTI not listed not listed not listed not listed 1 73 not listed 0.99
  • Comments Comments (
    0
    ) |
Minisling obturator 1 79 not listed
Total
Transobturator synthetic Pain, other (new or different after surgery) early post operative vaginal pain, VAS higher than 3 not listed not listed not listed not listed 22 60 not listed <0.001
  • Comments Comments (
    0
    ) |
Minisling obturator 1 77 not listed
Total
Transobturator synthetic Pain, groin (new or different after surgery) VAS higher than 3, resolved by 2 weeks 2 weeks post op not listed not listed not listed 22 60 not listed <0.001
  • Comments Comments (
    0
    ) |
Minisling obturator 0 77
Total
Transobturator synthetic Retention requiring surgery not listed after discharge not listed not listed 2 60 not listed not listed
  • Comments Comments (
    0
    ) |
Minisling obturator 2 77
Total
Transobturator synthetic post operative nocturia not listed after discharge not listed not listed 14 60 not listed 0.11
  • Comments Comments (
    0
    ) |
Minisling obturator 4 77
Total
Transobturator synthetic post operative frequency not listed after discharge not listed not listed 9 60 not listed 0.69
  • Comments Comments (
    0
    ) |
Minisling obturator 12 77
Total
Transobturator synthetic post operative urgency not listed after discharge not listed not listed 14 60 not listed 0.10
  • Comments Comments (
    0
    ) |
Minisling obturator 12 77
Total
Transobturator synthetic dyspareunia When related to tape, patients underwent office or OR tape removal not listed after discharge not listed not listed 0 60 not listed 0.03
  • Comments Comments (
    0
    ) |
Minisling obturator 5 77
Total
Transobturator synthetic retention requiring CISC not listed 1 week post op not listed not listed 6 60 not listed not listed
  • Comments Comments (
    0
    ) |
Minisling obturator 3 77
Total
Transobturator synthetic Transfusion post-op not listed in hospital yes not defined 0 73 not listed not listed
  • Comments Comments (
    0
    ) |
Minisling obturator 0 79
Total
Transobturator synthetic
  • Comments Comments (
    0
    ) |
Minisling obturator
Total