PHYSICIANS: ACT® For Women

ACT® is a minimally invasive urological implant designed to treat female patients who have stress urinary incontinence.

Important Safety Information About ACT

Incidence of Urinary Incontinence in Female Patients
Recurrent stress urinary incontinence (SUI) is the most common type of female incontinence in the 25- to 65-year-old age group.1 It can be a disturbing complication of intrinsic sphincter deficiency following childbirth or hysterectomy.
The prevalence of SUI in women is estimated to be:

• 17-28% in France
• 4.6-16.6% in Italy
• 13.5-28.5% in Spain
• 24.5-27.5% in the United Kingdom1

Risk factors for developing SUI include natural childbirth, obesity, diabetes mellitus, recurrent urinary tract infections, neurologicial diseases and chronic bronchitis or cough. Additionally, a history of gynecological surgery for prolapse or incontinence increases the risk of occurrence for SUI more than two-fold, while hysterectomy and other gynecological procedures increase the risk for stress urinary incontinence about 1.5 fold.1

Effective Treatment Following Failed Burch Procedure, Colposuspension, or Slingpasty
Conventional treatments, such as Artificial Urinary Sphincter (A.U.S.) or bulking agents, may have limited use or varied efficacy for female patients with stress incontinence. Adjustable Continence Therapy (ACT®) from Urologi Inc., Inc., offers female patients who have recurrent stress incontinence an effective treatment option after other therapies, such as a Burch procedure, colposuspension, collagen bulking agent, or slingpasty, have failed.
Benefits of ACT Therapy include:

• Effective for Type II and Type III Stress Urinary Incontinence
• Minimally invasive procedure (typically under 30 minutes) can be performed with local anesthesia
• 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
• Multiple lengths to meet your patients’ individual needs (7–9 cm)
• No fixation sutures or anchors required
• No abdominal or vaginal incisions
• Can be easily removed

The ACT Device for Treatment of Recurrent Urinary Incontinence Due to Intrinsic Sphincter Deficiency
The ACT Device consists of two post-operatively adjustable balloon implants placed via perineal approach bilaterally in a periurethral position at the bladder neck. The implant procedure is minimally invasive and may be performed with local anesthesia.
Titanium ports [Figure 1], attached via discrete tubing to each balloon, allow 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

The ACT Device is available in different sizes (7-9 cm) to fit the individual needs of your patients.
Urologi Inc. 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

Clinical Data Regarding Patients with Type II and Type III Stress Incontinence
In a clinical study of 49 female patients with Type III SUI, ACT Therapy seems to show “good efficacy at long-term follow-up.” After six months, 65% of patients were dry and another 16% were significantly improved [Figure 3].2

Figure 3. Overall Impression

All complications were minor and easily remedied. Twelve devices were removed in ten patients; reasons for device removal included migration, device failure, and urethral erosion.2
The most commonly reported complications included:

• balloon migration (12.2%)
• urethral erosion (2.0%)
• device failure (6.1%)

To order literature on Adjustable Continence Therapy, please feel free to contact us.