OBJECTIVE: To evaluate applicability, acceptance, side effects and complications and the possible curative effect on female stress urinary incontinence of the treatment with the urethral plug VIVA (Braun Melsungen, 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 patient clinic. Part II: 21 patients with urinary stress incontinence (SUI). MAIN OUTCOME MEASURES: Part I: Ability to hold the plug while walking and standing, acceptance rate of plug therapy. Part II: Subjective improvement of SUI, pad-weighing test, cough test, urinary tract infections, other complications during four months of plug treatment. RESULTS: Part I: 62% of 156 patients were able to hold the plug. 40% of 53 patients with SUI accepted 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 SUI 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 out from the study because of recurrent urinary tract infections. In one patient a plug migrated into the bladder and was removed cystoscopically. In two case reports the possibility of symptomatic plug treatment for patients with severe stress incontinence after surgical and radiological treatment of cervical cancer is demonstrated. CONCLUSIONS: Plug treatment is a broadening of the spectrum of conservative treatment of SUI as a symptomatic treatment in pat. with contraindications to anti-incontinence surgery and as a curative treatment in low grade SUI.
OBJECTIVE: To evaluate applicability, acceptance, side effects and complications and the possible curative effect on female stress urinary incontinence of the treatment with the urethral plug VIVA (Braun Melsungen, 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 patient clinic. Part II: 21 patients with urinary stress incontinence (SUI). MAIN OUTCOME MEASURES: Part I: Ability to hold the plug while walking and standing, acceptance rate of plug therapy. Part II: Subjective improvement of SUI, pad-weighing test, cough test, urinary tract infections, other complications during four months of plug treatment. RESULTS: Part I: 62% of 156 patients were able to hold the plug. 40% of 53 patients with SUI accepted 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 SUI 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 out from the study because of recurrent urinary tract infections. In one patient a plug migrated into the bladder and was removed cystoscopically. In two case reports the possibility of symptomatic plug treatment for patients with severe stress incontinence after surgical and radiological treatment of cervical cancer is demonstrated. CONCLUSIONS: Plug treatment is a broadening of the spectrum of conservative treatment of SUI as a symptomatic treatment in pat. with contraindications to anti-incontinence surgery and as a curative treatment in low grade SUI.