Results of a multicenter trial of the CapSure (Re/Stor) continence shield on women with stress urinary incontinence.
To prospectively study the impact of the CapSure (Re/Stor) Continence shield for the treatment of stress urinary incontinence.
One hundred women with pure stress urinary incontinence were enrolled in a 6-month study.
Objective measures of urine loss included pad weight test (PdWt) and provocative stress test (PST).
Subjective measures included incontinence diaries documenting the number of incontinence episodes per day (IEPD), quality of life questionnaires, and satisfaction surveys.
Objective and subjective measures were performed prior to enrollment, during use of the CapSure shield, and after discontinuation of the device.
During the 12-week device utilization period, PdWt measurements demonstrated a 96% reduction in urine loss by week 1 and 97% by week 12.
Eighty-two percent of subjects were completely dry by week 12.
PST demonstrated 100% reduction in urine loss at each visit, with 91% of subjects completely dry by week 12.
IEPD also demonstrated a 91% reduction in incontinence episodes by week 12.
Quality of life scores and patient satisfaction surveys demonstrated significant improvement.
During the 6-week post device utilization period (PUP), subjects continued to demonstrate a reduction in urine loss compared to pre-enrollment data, despite discontinuation of use.
PdWt measurements demonstrated a 73% and 79% reduction in urine loss at weeks 14 and 18, respectively. (...)
Mots-clés Pascal : Incontinence urinaire effort, Traitement, Dispositif fermeture, Voie urinaire, Méat urétral, Equipement, Evaluation performance, Homme, Femelle, Appareil urinaire pathologie, Voie urinaire pathologie, Vessie pathologie, Trouble miction, Equipement biomédical
Mots-clés Pascal anglais : Urinary stress incontinence, Treatment, Lock out device, Urinary tract, Urethral meatus, Equipment, Performance evaluation, Human, Female, Urinary system disease, Urinary tract disease, Bladder disease, Voiding dysfunction, Biomedical equipment
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0277236
Code Inist : 002B26G. Création : 27/11/1998.