Abstract
A consecutive series of 59 women with urodynamic stress incontinence but no prolapse were offered treatment with Contiform (available in small/medium/large sizes). The 24-h pad test was the primary outcome measure. Of the 59 enrolled women, 41 (69%) completed the trial protocol. Median use was 21 days (IQR 10–24.5). Two severity groups were categorized based on pretreatment pad testing (mild <30 g/day n=24 patients, 59%) and moderate/severe >30 g/day, n= 17(41%). Overall, loss was reduced by a median of 72% (5–92), p<0.0001, with the greatest reduction seen in the moderate/severe group of 85% (75–100) p<0.0001. No significant benefit on pad testing was noted in the mild group. Both groups showed significant benefit on the Incontinence Impact Questionnaire. The insertion technique was quickly learnt and the device well tolerated. A medium-sized Contiform was used by 33 (80%) women. No serious adverse events occurred.
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FDA original master file 7760, 5600 Fisher’s Lane, Rockville, Maryland 20857. www.fda.gov
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Editorial Comment: Intravaginal and intraurethral devices have been utilized with variable but only modest success in managing women with stress urinary incontinence. Although future studies might focus on a prospective randomized study design comparing this device to other devices used for incontinence, the authors took the first appropriate step in prospectively determining the effects of the intervention both before and afterwards. It is interesting that only the group with more severe incontinence had an appreciable benefit. With the current study, this amounted to improvement in only 17 of the original 59 subjects, or 29% of subjects who used the device. None the less, the apparent ease of insertion and patient tolerance present this device as another possible option in the management of stress incontinence with minimal adverse effects.
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Morris, A.R., Moore, K.H. The Contiform incontinence device – efficacy and patient acceptability. Int Urogynecol J 14, 412–417 (2003). https://doi.org/10.1007/s00192-003-1094-8
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DOI: https://doi.org/10.1007/s00192-003-1094-8