What is the effectiveness of the ProAct (Adjustable Continence Therapy) procedure for treating stress urinary incontinence?

Effectiveness of the ProACT Bladder Procedure for Stress Urinary Incontinence

The ProACT (Adjustable Continence Therapy) procedure shows moderate effectiveness for treating male stress urinary incontinence after prostate surgery, with success rates of 67-68% in patients with mild to moderate incontinence, but significantly lower success rates (only 46%) in patients who have undergone radiation therapy. 1, 2

Efficacy Data

Success Rates

• In a multicenter study with 240 patients, 29.6% were completely dry and 37.5% showed significant improvement (>50% reduction in urine leakage) at 24 months follow-up 2
• For patients with moderate to mild incontinence, success rates reach approximately 68%, while the explantation rate is around 18% 1
• Five-year follow-up data on 152 patients showed similar efficacy rates to the 24-month results, suggesting durability of the treatment 2

Quality of Life Improvements

• Mean quality-of-life index scores increased from 48 to 67 at 12 months in one study 3
• The Incontinence Quality of Life (IQOL) score improved from a median of 31.7 at baseline to 71.1 at 12 months in another study 4
• Daily pad usage typically decreases from 4-5 pads per day before treatment to 1-2 pads per day after treatment 3, 1, 4

Patient Selection Factors

Favorable Candidates

• Patients with mild to moderate stress urinary incontinence 1, 2
• Patients without prior pelvic radiation therapy 3, 1
• Patients with post-prostatectomy incontinence who prefer a minimally invasive approach 5

Poor Candidates

• Patients with severe incontinence (lower success rates) 1
• Patients who have undergone radiation therapy (only 46% success rate and higher risk of urethral erosion) 1
• Patients with significant comorbidities (predictive factor for lower satisfaction) 5

Procedure Characteristics

Technical Aspects

• Minimally invasive procedure involving placement of two adjustable balloons on either side of the urethra 3, 1
• Average procedural time of approximately 37 minutes 3
• Performed under general or spinal anesthesia 3
• Balloons can be adjusted postoperatively to optimize continence 1, 4

Adjustments

• Most patients (88%) require balloon adjustments to achieve optimal results 3
• The average number of adjustments needed is three (range 0-9) 4
• The mean optimal volume after adjustments is approximately 3.8 mL per balloon 3

Complications

Common Complications

• Overall complication rate of approximately 22.5% 2
• Balloon failure/deflation (most common long-term complication) 2
• Infection (2-3%) 3, 4
• Erosion (7.6-8%) 3, 4
• Migration (3%) 4

Management of Complications

• Device removal is required in 9-19% of patients 3, 4
• Removal can be performed under local anesthesia 4
• Reimplantation is possible after healing in some cases 3, 4
• Most complications occur within the first postoperative month 3

Comparison to Other Treatments

Context in Treatment Algorithm

• The artificial urinary sphincter remains the standard treatment for severe male stress urinary incontinence 2
• ProACT represents an option for moderate male stress urinary incontinence, especially given its minimally invasive nature 1
• For female stress urinary incontinence, other options like midurethral slings are more commonly used 6
• Non-surgical options like pelvic floor muscle training should be considered before surgical interventions 6

Clinical Pearls

• The procedure is technically feasible with a relatively short operative time 3
• Patients should be counseled about the likely need for postoperative adjustments 3, 4
• The relative reversibility of the procedure is an advantage compared to more invasive options 1
• Radiation therapy significantly reduces success rates and increases complication rates 3, 1
• Long-term efficacy appears to be maintained based on 5-year follow-up data 2