The Adjustable Continence Therapy (ProACT 22) for Male Stress Urinary Incontinence - International Multi-Centre Evaluation

 

Introduction and Objectives

The Adjustable Continence Therapy (ProACT™) was first used as a minimally invasive treatment for male stress urinary incontinence in 2000.

Using subjective and objective parameters this study aimed to evaluate the efficacy of ProACT in males with incontinence resulting from various aetiologies

Methods

Implantation of the ProACT device involves the insertion of two balloons adjacent to the urethra. Each balloon is attached to a port placed in the scrotum facilitating postoperative adjustment by percutaneous injection in the clinic. Three hundred and twenty nine patients in 4 international centres have been implanted between 2001 and 2005. Prior to implantation, completion of the Incontinence Quality of Life score (IQoL) and daily pad usage was recorded. These assessments were repeated at 1, 3, 6 and 12 months and annually thereafter. A minimum of 24-months of follow-up was obtained from all patients.

Results

IQoL improved from 41.6 (range 11.3- 94.3) at baseline to 77.4 (range 10.9- 100) at 12 months, 74.6 (10.2-100) at 24 months, 78.8 (32-100) at 36 months at 76 (20-100), at 48 months and 72 (13-100) at 60 months. Pad usage reduced from a mean of 4.2 at baseline to 1.2 at 12 months, 1.04 at 24 months, 1.2 at 36 months, 1.3 at 48 months and 1.1 at 60 months. Sixty five percent of patients were dry (<1 pad per day) at 2 years with 54% of patients still dry (<1 pad per day) at 5 years. Balloon adjustments were performed as required in order to achieve and maintain continence. Eight two percent of patients required adjustments with a mean of 4.7 (0-11) adjustments being undertaken and a final mean balloon volume of 4.2 at 2 years. Complications of infection and erosion (9.8%); migration (9.3%); balloon rupture (8.7%); pain and discomfort (2.5%). were reported. Eighteen percent of patients underwent alternative treatments due to non-response or following device removal arising from adverse events (AUS- 29) (Slings- 6). Device removal was easily performed without adverse sequelae allowing for reimplantation or further surgical intervention.

Conclusions

ProACT is a safe, effective and durable treatment for male stress urinary incontinence. The ability to titrate over time enhanced the sustained improvement as demonstrated by an increase in Quality of Life and reduction in pad usage.

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