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A urinary control device for management of female stress incontinence
D G Tincello1, E J Adams, J Bolderson
1Department of Obstetrics and Gynaecology, University of Liverpool, United Kingdom. tincello@liv.ac.uk
Objective:
To examine the performance of a silicon urinary control device for nonsurgical management of women with genuine stress incontinence.
Methods:
A 3-month prospective study involved 41 women with genuine stress incontinence. They completed urinary diaries of voiding, incontinence, and severity of incontinence on a 4-point scale over a week. Subjects were taught how to apply the device and used it as required from the second week. Visual analogue scales were used to record aspects of use (such as acceptability, comfort, and ease of application), and 2-hour perineal pad tests were completed at recruitment, after 2 weeks, and after 3 months. Data were compared by Mann-Whitney U test, or Wilcoxon test.
Results:
Ten women (24.4%) declined to participate and six (14.6%) withdrew before 2 weeks. Ten (24.4%) failed to attend for 2-week follow-up and 11 (26.8%) did not continue for 3 months. Two (4.9%) did not attend 3-month follow-up. Only two women (4.9%) completed the study. There was no difference in pad test results or in results from voiding diaries.
Conclusion:
The urinary incontinence device had low acceptability and was ineffective, and we cannot recommend it for nonsurgical management of genuine stress incontinence.