 Dear Physician,
Welcome to the third issue of the ProACTivities Newsletter, published to coincide with the Annual Meeting of the European Urological Association, on March 26-29 in Milan, Italy. We hope to see you at the Medtronic booth C04.
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| ACT® Abstract Presented at SUFU Meeting
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Significant Improvements reported in 139 ACT Patients at one year follow-up.
(presented at SUFU/I-Spin Winter Meeting, Society for Urodynamics and Female Urology, February 28-March 2, 2008, Miami, Florida).
Dr. Dennis Kim, from Kaiser Permanente Los Angeles, presented the most recent data of the FDA ACT study on behalf of Dr. Aboseif and the ACT Study Group. Dr. Kim's abstract reports on 161 implanted patients, 137 of which have one year follow-up data. Stamey score improvement ≥1 was seen in 76.6% of patients (82/107). Quality of life score improved from a mean of 36 at baseline to 70.5 at 1 year. Pad weight (during 1 hour provocative pad weight test) reduced from 49.7 grams at baseline to 11.9 grams at 1 year. Mean number of balloon adjustments through 1 year was 2.1 (0-8). Device or procedure related adverse events were reported in 56.2% of patients (81% of which were rated mild).
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| ACT® and ProACT™ Down Under: Australasian Meeting
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The Urological Society of Australia and New Zealand held its 61st Annual Scientific Meeting in late February in Hong Kong. The meeting was preceded by a well-attended workshop on the treatments of male incontinence where ProACT was highlighted by Dr. Peter Chin from Wollongong, Australia.
During the meeting, Dr. Chin presented on his experience with 50 male and female patients. Pad usage decreased from 4.3 at baseline to 0.75 at 12 months and 0.25 at 24 months. Improvement was also reported in quality of life. Complications included erosion/infection, migration, labial discomfort, and non-response.
Dr. Gilling, Tauranga, New Zealand, presented on a multicenter study with 226 enrolled ProACT patients with at least 12 months follow-up. Revisions occurred due to erosion, migration, or non-response to initial surgery. Pad usage reduced from 4.3 at baseline to 1.3 at 12 months, Quality of Life improved from 36.8 to 72.2 at 12 months. A second abstract presented by Dr. Gilling evaluated the impact on urinary flow rate after ProACT placement and concluded that there is no discernible reduction in urinary flow following placement of ProACT balloons, suggesting that simple obstruction is not the (only) mechanism of action.
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| Hot Off the Press
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 Etude Française prospective multicentrique de l'utilisation des Ballons ACT® pour le traitement de l'incontinence urinaire d'effort chez la femme. Chartier-Kastler E et.al. Progrès en Urologie (2007), 17, 1372-1377. This article reports on a study carried out in four French centers, during which 68 patients with SUI were included. Evaluation of patients (mean follow-up: 2 years) after implantation revealed a marked improvement of incontinence (87%), DVST (85%) and I-QoL (score 75/100). ACT was removed in 18 cases for various reasons (8 due to absence of efficacy) and re-implanted in 6 cases. The authors conclude that ACT balloon implantation is a new, reversible and promising minimally invasive technique for the management of female stress urinary incontinence. View the full abstract. |
Five Abstracts to be Presented at EAU
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During the upcoming EAU Annual Meeting (March 26-29) in Milan there will be significant discussion on ACT and ProACT. In addition to the five abstracts that will be presented, there will also be discussions on - ProACT during the ESFFU (European Society of Female and Functional Urology) Meeting on the 26th (with Dr. Hübner as invited speaker) and
- a Subplenary session on Thursday the 27th where post-prostatectomy incontinence and treatments, including ProACT, will be discussed by Prof. Jünemann.
Upcoming Five Abstracts Adjustable Continence Therapy (ACT) for recurrent female SUI-four year experience. Kocjancic E et.al. This important abstract demonstrates the long-term efficacy of ACT as demonstrated in a significant drop in pad use (avg. 5.31 at baseline with n=49 vs. avg. of 0.5 at four years with n=28) and improvement in Quality of Life (31.4 at baseline (n=49) vs. 93.8 at four years (n=28) follow-up). 65% of patients were completely dry at last follow-up. Adverse events included 1 balloon erosion and 6 balloon migrations necessitating device removal. Four of 5 patients who underwent re-implantation had successful outcomes.  International multi-center evaluation of the adjustable continence therapy (ProACT) for male post prostatectomy SUI, Gilling P. Even more significant are the results of this abstract which reports the results of 329 implanted patients with a minimum follow-up of two years. Quality of Life improved from 41.6 at baseline to 74.6 at 24 months; pad usage reduced from 4.2 at baseline to 1.04 at 24 months. 65% of patients were considered dry (< 1 pad per day) at two years follow-up. Mean number of adjustments required was 4.7 per patient. Complications included erosion, migration or non-response to initial surgery. Device removal was easily performed.  Patient perceived outcome and objective success rate in the treatment of post prostatectomy incontinence (PPI) after long-term follow up; results of three different surgical approaches. Huber E et.al. Study compares the results of three surgical procedures commonly performed to treat PPI (ARGUS, AUS and ProACT). Pad test showed similar dry rates for all three techniques (71% of ProACT dry; 70% of Argus and 75% of AUS). The only significant difference was a lower Qmax for ARGUS. ProACT represents the least invasive procedure. Patients may have a willingness to trade a slightly lower success rate in favor of a more minor treatment. Complications were not compared in this abstract.
Transrectal ultrasound-guided implantation of the ProACT system in patients with post-radical prostatectomy stress urinary incontinence; preliminary clinical results of a prospective study. Gregori A et.al. Report on 28 patients (mean follow-up of 16 months) implanted with ProACT under TRUS guidance, who had completed balloon adjustments (4.4 adjustments on average). 78.5% of patients are dry, 10.7% are improved and 10.7% were failures. Incontinence Quality of Life (IQoL) improved from 46.7 to 91.5. Complications included one bladder perforation and two unilateral balloon migrations.
Adjustable continence therapy for the treatment of male urodynamic stress urinary incontinence; single center study. Kocjancic E. 65 patients were implanted with a mean follow-up of 19.5 months. 68% of patients were dry with 16% improved and 14% unchanged. IQoL increased from 31.7 to 63.4 at last follow-up. Complications resulting in balloon explant occurred in 11 patients (erosion: 5/65; infection 2/65; migration 2/65 and balloon failures 2/65). |
Report Indicates 365,500 Men Suffer from Severe and Debilitating SUI.
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This recently published report highlights the significant size of this underserved population of patients. Total number of male patients in Europe with chronic and debilitating SUI (as a result of prostatectomy) is approximately 365,500. As of 2006, only about 2.6% of this population (about 9,500 patients) was being treated with curative surgical techniques every year.
Injectable bulking agents are expected to continue to decline due to competition from more cost-effective alternative products and due to lack of long-term proof of durability or clinical efficacy in treating the post-prostatectomy SUI population. From: "European markets 1 for the surgical treatment of male urinary incontinence" Published by: Medtech Insight, December 2007 1For the purpose of this study, Europe is defined as: Germany, France, Italy, Spain, United Kingdom and the Benelux.
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| Contact Uromedica
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The use of ACT ® and ProACT™ is growing significantly and to date around 6000 patients have been implanted with this minimally invasive device which can be non-invasively adjusted until the patient reaches the desired level of continence. Uromedica, Inc. was formed in 1997 to develop minimally invasive medical devices that treat unmet medical needs in the area of urogenital and related disorders. Adjustable Continence Therapy (ACT ® Therapy for women and ProACT™ Therapy for men) from Uromedica, Inc. is designed to treat stress urinary incontinence with confidence. 1840 Berkshire Lane North Plymouth, MN, 55441 United States of America Tel: +1-763-694-9880 Fax:+1-763-694-9945 Website |
If you have anything to report related to ACT and ProACT or if you have other feedback, please contact Ben Wasscher at Uromedica for possible inclusion in future issues.
I look forward to seeing you at upcoming congresses,
Ben Wasscher
Sales & Marketing Director
Uromedica, Inc.
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Not intended for distribution to a United States Audience. These devices are not commercially available in the United States. Available in selected markets outside the United States only.
 Important Safety Information
ACT® Brief Summary of Safety Information for Physicians
Product Technical manual must be reviewed prior to use for detailed disclosure.
Indications: The ACT system is indicated for use in the correction of stress urinary incontinence in females.
Contraindications: Contraindications include active systemic or urinary tract infections, pregnancy, unmanageable detrusor instability, reduced bladder compliance, pretreatment urge incontinence symptoms refractory to medication, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ACT system implantation, bladder cancer or bladder stones, bleeding disorders.
Warnings/Precautions/Adverse Events: The ACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ACT device must be performed by a physician. If X-ray is used, adequate attention must be given to the potential radiation exposure. Perforation of the bladder, urethra or vagina during dilation of the tissue from the labia to the bladder neck should be avoided. Do not use excessive force to advance or withdraw the device if resistance is encountered. Do not attempt to place or introduce the device without the supplied push wire. Do not place the device in a location where the patient may have problems with urinary retention or erosion. Do not place the device immediately adjacent to the urethral mucosa. This could result in balloon erosion or migration. Do not place the device in a location where there are surgical staples, steel suture or other artifacts from previous interventions. Device wear and/or puncture may result. Do not inflate the balloon with more than 8.0 ml of isotonic contrast solution. Use the correct mixture of sterile water and contrast media to provide an isotonic contrast solution for inflation of the ACT balloons. Do not use the implantation instruments without prior cleaning and steam sterilization. The ACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If ACT balloon failure, or bladder, urethra or vaginal wall perforation occur, do not implant and ACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. If the patient becomes pregnant after ACT implantation, the primary physician must closely monitor the patient for any adverse effects associated with the device during pregnancy. Failure of the device may result if the ACT device is handled with any sharp instruments or laid against an abrasive material. ACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. It is advisable to use the same type of contrast media as used during the original filling of the balloons when performing a post surgical adjustment. The patient should refrain from heavy lifting and exercise for 3 to 4 weeks postoperatively and refrain from intercourse for one month. Advise the patient to contact the surgeon immediately if bleeding or other problems occur. Potential adverse events include, but are not limited to tissue perforation (tear), device migration, tissue erosion/infection at the implant site, device failure, non-response to treatment, post-operative urgency, frequency or retention.
Rx Only.
ProACT™ Brief Summary of Safety Information for Physicians
Product Technical manual must be reviewed prior to use for detailed disclosure.
Indications: The ProACT system is indicated for use in the correction of stress urinary incontinence in males arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for BPH.
Contraindications: Contraindications include active systemic or urinary tract infections, unmanageable detrusor instability, reduced bladder compliance, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ACT system implantation, bladder cancer, unsuccessfully treated bladder stones, hemophilia or bleeding disorders.
Warnings/Precautions/Adverse Events: The ProACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ProACT device must be performed by a physician. If X-ray is used, adequate attention must be given to the potential radiation exposure. Perforation of the bladder, urethra or rectum during dilation of the tissue from the perineal area to the bladder neck should be avoided. Do not use excessive force to advance or withdraw the device if resistance is encountered. Do not attempt to place or introduce the device without the supplied push wire. Do not place the device in a location where the patient may have problems with urinary retention or erosion. Do not inflate the balloon with more than 8.0 cc. Do not place the device immediately adjacent to the urethral mucosa. This could result in balloon erosion or migration. Use the correct mixture of sterile water and contrast media to provide an isotonic contrast solution for inflation of the ACT balloons. Do not use the implantation instruments without prior cleaning and steam sterilization. Do not place the device in a location where there are surgical staples, steel suture or other artifacts from previous interventions. Device wear and/or puncture may result. The ACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If bladder perforation occurs, do not implant the ProACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. Failure of the device may result if the ACT device is handled with any sharp instruments or laid against an abrasive material. Do not grasp the port or strain relief with clamps. ProACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. It is advisable to use the same type of contrast media as used during the original filling of the balloons when performing a post surgical adjustment. Potential adverse events include, but are not limited to tissue perforation (tear), device migration, post-operative urgency, frequency or retention, tissue erosion/infection at the implant site, device failure, and non-response to treatment.
Rx Only.
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