Objective: To examine the performance of a silicon urinary control device f
or 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 taug
ht how to apply the device and used it as required from the second week. Vi
sual analogue scales were used to record aspects of use (such as acceptabil
ity, comfort, and ease of application), and 2-hour perineal pad tests were
completed at recruitment, after 2 weeks, and after 3 months. Data were comp
ared 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 fo
llow-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 i
neffective, and we cannot recommend it for nonsurgical management of genuin
e stress incontinence. (Obstet Gynecol 2000;95:417-20. (C) 2000 by The Amer
ican College of Obstetricians and Gynecologists.).