Men: ProACT
ProACT™ Therapy For Post-Prostatectomy Stress Incontinence
Incidence of Urinary Incontinence in Male Patients
In 1999, an estimated 179,300 men were expected to be diagnosed with prostate cancer in the United States alone, many of whom would require a radical prostatectomy.1 Recurrent stress incontinence is often a disturbing complication following this surgical removal of the prostate. A recent study revealed that 18 months after radical prostatectomy, 8.4% of patients were incontinent (frequent urinary leakage or no urinary control) and 59.9% of men were impotent.2
Prevalence estimates of post-prostatectomy stress incontinence vary from 6-69%, depending on the method used to measure incontinence and surgeon skill. Retrospective physician studies typically report lower incontinence rates than patient reported outcomes.3
Effective Treatment for Stress Urinary Incontinence
Prior treatment methods (e.g., male slings, pelvic floor exercises, bulking injections) have produced varying rates of efficacy for patients suffering post-prostatectomy stress urinary incontinence (SUI).
Adjustable Continence Therapy (ProACT™) from Uromedica, Inc., is a minimally invasive urological implant designed to treat male patients who have stress urinary incontinence arising from intrinsic sphincter deficiency following radical prostatectomy for prostate cancer or transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH).
ProACT Therapy offers an effective first-line treatment option for post-prostatectomy incontinence before invasive surgical consideration or implant of an Artificial Urinary Sphincter (A.U.S.) or adjustable sling. Median time to regain continence after radical prostatectomy is ~3 months;4 if a patient still leaks after six months, it is worthwhile to consider ProACT Therapy.
Benefits of ProACT Therapy include:
- Minimally invasive (short) implant procedure
- Non-surgical, post-operative adjustability
- Silicone balloon offers long-term durable prosthetic
- Subcutaneous port offers easy access for adjustments in balloon volume
- Is not absorbed like particulate bulking agents
- Two lengths to meet your patient’s individual needs (12 cm and 14 cm)
- No fixation sutures or anchors required
- Can be removed easily
Important Safety Information About ProACT
The potential risks with the ProACT implant procedure are similar to those for other surgical treatments for stress urinary incontinence. These include, but are not limited to, the following:
- Tissue perforation (tear)
- Device migration
- Post-operative urgency, frequency or retention
- Tissue erosion/infection at the implant site
- Device failure
- Non-response to treatment
If an infection occurs at the implant site, it can be treated with antibiotics. If a more serious side effect occurs (e.g., perforation, migration), ProACT can be completely removed.
The ProACT Device for Treatment of Recurrent Stress Incontinence Resulting from Intrinsic Sphincter Deficiency
The ProACT Device consists of two post-operatively adjustable balloon implants placed via perineal approach bilaterally in a periurethral position at the bladder neck or at the apex of the prostatic remnant. The implant procedure is minimally invasive and may be performed with general or spinal anesthesia.
Titanium ports [Figure 1], attached via discrete tubing to each balloon, are placed in the scrotum, allowing for subcutaneous, post-operative volume adjustment. Increasing the balloon volumes will increase coaptation of the urethra and lift the bladder neck, which may improve continence. Adjustments can continue to be made to best meet the needs of the patient.
Figure 1. Cross-Section of Implantable Balloon
ProACT is available in two sizes (12 cm and 14 cm) to fit the individual needs of your patients.
Uromedica has developed a set of dedicated implant tools for the Adjustable Continence Therapy. The set consists of a u-channel sheath, a blunt and a sharp trocar and a tissue expanding device (TED) [Figure 2].
Figure 2. Dedicated Implant Tools
To find a ProACT Therapy distributor near you, refer to the Distributors page.
Clinical Data Regarding Patients with Post-prostatectomy Stress Incontinence
In a clinical study, ProACT Therapy produced “durable outcomes equivalent or better than other minimally invasive treatments for incontinence after prostatectomy.” After a mean follow-up of 13 months, 67% of men were dry and 92% were significantly improved.5
Participants also reported using fewer pads [Figure 3] and a lower Stamey Score [Figure 4] after ProACT Device implant. Complications experienced were mostly minor and decreased with increasing experience. Complications experienced include perforation, retention, balloon rupture, migration, erosion and explant.5
Figure 3. Pad Usage After ProACT Implant
Figure 4. Improvement in Stamey Score After ProACT Implant
To review a listing of the latest journal articles and abstracts related to Adjustable Continence Therapy, please visit the Bibliography page.
To order literature on Adjustable Continence Therapy, please fill out the Physician Order Form page.
Footnotes
1 Landis SH, et al. Cancer Statistics, 1999. CA Cancer J Clin. 1999:9;8-31.
2 Stanfor JL, et al. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer. JAMA. January 19, 2000:283(3);354-360.
3 Wei JT, et al. Prospective assessment of patient reported urinary continence after radical prostatectomy. J Urol. September 2000:164;744-748.
4 Young MD, et al. Urinary continence and Quality of life in the first year after radical perineal prostatectomy. J Urol. December 2003:170;2374-2378.
5 Hübner WA, Schlarp OM. Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy. Br J Urol. Sep 2005:96(4);587-94.
—This page last modified Tuesday February 12, 2008