OBJECTIVE: Our purpose was to evaluate a vaginal device designed to support the bladder neck in women with urinary stress incontinence. STUDY DESIGN: Thirty-two physically active incontinent women underwent urodynamic evaluation and maintained a bladder diary before enrollment and after 4 weeks of device use. Outcome measures included changes in number of reported incontinence episodes, urine loss on stress testing, and changes in urodynamic parameters with the device in place. Patient comfort, convenience, and satisfaction were also evaluated. RESULTS: Thirty women completed the study. Twenty-five (83%) were dry with the device in place. Weekly incontinence episodes decreased from 10 to three (p < 0.05). Significant changes in functional urethral length, pressure transmission ratio, and urethral cotton swab stress angle were noted. No evidence of urethral obstruction was noted. The subjects found the device comfortable, easy to use, and convenient. CONCLUSION: The bladder neck support prosthesis reduces stress incontinence and normalizes urodynamic parameters in the same manner as a colposuspension.
OBJECTIVE: Our purpose was to evaluate a vaginal device designed to support the bladder neck in women with urinary stress incontinence. STUDY DESIGN: Thirty-two physically active incontinent women underwent urodynamic evaluation and maintained a bladder diary before enrollment and after 4 weeks of device use. Outcome measures included changes in number of reported incontinence episodes, urine loss on stress testing, and changes in urodynamic parameters with the device in place. Patient comfort, convenience, and satisfaction were also evaluated. RESULTS: Thirty women completed the study. Twenty-five (83%) were dry with the device in place. Weekly incontinence episodes decreased from 10 to three (p < 0.05). Significant changes in functional urethral length, pressure transmission ratio, and urethral cotton swab stress angle were noted. No evidence of urethral obstruction was noted. The subjects found the device comfortable, easy to use, and convenient. CONCLUSION: The bladder neck support prosthesis reduces stress incontinence and normalizes urodynamic parameters in the same manner as a colposuspension.