THE VIVA-URETHRAL PLUG - A BROADER THERAP EUTIC SPECTRUM FOR MANAGEMENT OF FEMALE URINARY STRESS-INCONTINENCE

Objective: To evaluate applicability, acceptance, side effects and com plications and the possible curative effect on female stress urinary i ncontinence of the treatment with the urethral plug VIVA(R) (Braun Mel sungen, Germany). Design: Part I: Prospective clinical study. Part II: Ongoing prospective-longitudinal study. Additionally two case reports . Subjects: Part II: 156 consecutive patients of the urodynamic out pa tient clinic. Part II: 21 patients with urinary stress incontinence (S UI). Main outcome measures: Part I: Ability to hold the plug while wal king and standing, acceptance rate of plug therapy. Part II: Subjectiv e improvement of SUI, pad-weighing test, cough test, urinary tract inf ections, other complications during four months of plug treatment. Res ults: Part I: 62% of 156 patients were able to hold the plug. 40% of 5 3 patients with SUI accpeted the plug treatment. Part II: 14 patients completed the study. 4 pat. were subjectively and objectively cured, 3 were improved, 7 unchanged. The cured patients all had a low grade SU I with a urine loss of 3 g in the pad-weighing test before treatment. 12/21 pat. showed 1-2 urinary tract infections and 1 patient dropped o ut from the study because of recurrent urinary tract infections. In on e patient a plug migrated into the bladder and was removed cystoscopic ally. In two case reports the possibility of symptomatic plug treatmen t for patients with severe stress incontinence after surgical and radi ological treatment of cervical cancer is demonstrated. Conclusions: Pl ug treatment is a broadening of the spectrum of conservative treatment of SUI as a symptomatic treatment in pat. with contraindications to a nti-incontinence surgery and as a curative treatment in low grade SUI.