Adjustable continence balloons: clinical results of a new minimally invasive treatment for male urinary incontinence.

Objective: This study aimed to evaluate the results of the Danish experience with the ProACT urinary continence device inserted in men with stress urinary incontinence.

Material and methods: The ProACT was inserted in 114 patients. Data were registered prospectively. The main endpoints were complications, pad use per day and 24 h urinary leakage. A questionnaire evaluating symptoms and satisfaction was sent to the patients.

Results: Data including preoperative and postoperative pad use and urinary leakage were available for 92 and 90 patients, respectively. A decrease in the median 24 h urinary leakage (352.5 vs 11 ml, p < 0.001) and in the median number of pads used per day (4.75 vs 2.25, p = 0.001) was demonstrated. Forty-six patients had a pad use of 0-1 pads per day and/or a daily urinary leakage less than 8 g, corresponding to an overall dry rate of 50%. A decrease in urinary leakage > 50% was seen in 72 patients (80%). Complications were seen in 23 patients. All of these were treated successfully by removal of the device in the outpatient setting followed by replacement of the device. Another eight patients had a third balloon inserted to improve continence further. Fourteen patients (12%) ended up with an artificial sphincter or a urethral sling. Sixty patients (63%) experienced no discomfort and 58 (61%) reported being dry or markedly improved. Overall, 50 patients (53%) reported being very or predominantly satisfied.

Conclusions: Adjustable continence balloons seem to be a good alternative in the treatment of male urinary incontinence. Complications are mild and easily treated.