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Study Title and Description

Mersilene mesh sling: short- and long-term clinical and urodynamic outcomes



Key Questions Addressed
2 Sling Adverse Events
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Primary Publication Information
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TitleData
Title Mersilene mesh sling: short- and long-term clinical and urodynamic outcomes
Author Young SB, Howard AE, Baker, SP
Country UMass Memorial Healthcare, Division of Urogynecology and Pelvic Reconstructive Surgery, Worcester, MA
Year 2001
Numbers Pubmed ID: 11483900
2 (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 Synthetic PVS
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Type Prospective Cohort (all received same sling)
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Study Country US
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Sling Category Pubovaginal (bladder neck)
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Other ... Pubovaginal sling WITH synthetic mesh
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Multicenter? No
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Institution Type Academic hospital
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No. of Surgeons Performing the Procedures 1
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Surgeons' Training Urogynecology
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Residents or Fellows Performing the Surgery? Unclear/Not reported
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Adverse Event Ascertainment Unclear/Not reported
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Was the Clavien-Dindo Classification of Surgical Complications system used? No / Not reported
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Was a data safety monitoring board used? No / Not reported
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Study Sponsor/Funding Not reported
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Comments (overall study) AE's poorly defined
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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
Synthetic PVS overall complication rate "38 patients had 43 complications directly related to the sling procedure"
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Total Mean 30 months f/u Both Not described Not defined 43 200 n/a n/a
Synthetic PVS retention "retention beyond 1 year"
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Total Mean f/u 30 mos After discharge Not described Not defined 3 200 n/a n/a
Synthetic PVS Mesh erosion/extrusion/exposure/granulation tissue "failure / erosion that required complete sling removal"
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Total Mean f/u 30 mos After discharge Not described Not defined 1 200 n/a n/a
Synthetic PVS refractory DI "refractory detrusor instability"
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Total Mean f/u 30 mos After discharged No Not defined 2 200 n/a n/a
Synthetic PVS ISC "urinary retention requiring self-catheterization beyond 3 months"
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Total Mean f/u 30 mos After discharge No Not defined 7 200 n/a n/a
Synthetic PVS seroma / hematoma "early unilateral groin collection consisting of a superficial seroma or abscess, unconnected to the mesh and cured with a single I&D"
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Total Mean f/u 30 mos Not described Not sure Not defined 5 200 n/a n/a
Synthetic PVS "treated sucessfully for a trapped inguinal nerve"
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Total Mean f/u 30 mos Not described Not sure Not defined 1 200 n/a n/a
Synthetic PVS Organ injury in OR (urethra, bladder, bowel) "cystotomy"
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Total Intraop In hospital Not sure Not defined 1 200 n/a n/a
Synthetic PVS Pain, groin (new or different after surgery) "groin pain"
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Total Mean f/u 30 mos Not described Not sure Not defined 1 200 n/a n/a
Synthetic PVS "thigh numbness"
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Total Mean f/u 30 mos Not described No Not defined 1 200 n/a n/a
Synthetic PVS Infection, UTI "recurrent UTI and are cystoscopically normal
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Total Mean f/u 30 mos After discharge Not sure Not defined 7 200 n/a n/a
Synthetic PVS Mesh erosion/extrusion/exposure/granulation tissue "seven patients had vaginal and one inguinal sling erosion and are healed after revision"
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Total Mean f/u 30 mos After discharge Not sure Not defined 7 200 n/a n/a
Synthetic PVS Pain, other (new or different after surgery) "vaginal pain 3 years after undergoing the sling procedure"
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Total 3 years After discharge Not sure Not defined 2 200 n/a n/a
Synthetic PVS
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