 This is already the fourth issue of the ProACTivities Newsletter. We are very pleased to be able to report that two abstracts on our therapies were selected best in session at the EAU meeting. In this issue we also review the AUA and we report on two recently published articles in our "Hot off the Press" segment.
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| Two Adjustable Continence Therapy Abstracts Selected for Best Paper Recognition at EAU
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In issue #3 of ProACTivities, we presented a preview on the scientific activity involving ProACT™ at the EAU. Two of the abstracts received the award for best poster in their session. The best poster in the session on "Male Incontinence" was Patient perceived outcomes and objective success rates in the treatment of post-prostatectomy incontinence (PPI) after a long term follow-up: results of three different surgical approaches, presented by Dr. Wilhelm Hübner from Korneuburg, Austria. The best poster in the session on "Stress Incontinence-Tapes, New Concepts and More" was Adjustable Continence Therapy (ACT®) for recurrent female stress urinary incontinence, 4 year experience, presented by Dr. Ervin Kocjancic from Udine, Italy.
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| AUA Review
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Presentations on ACT and ProACT at AUA Annual MeetingTwo abstracts and one video abstract were presented at the recently held annual meeting of American Urological Association in Orlando.  International long term evaluation of the Adjustable Continence Therapy (ProACT) for male post prostatectomy stress urinary incontinence. Hübner W et.al. Presentation reports on experience with 329 implanted patients with a minimum follow-up of 24 months. IQoL score improved from 41.6 at baseline to 74.6 at 24 months. Pad usage reduced from a mean of 4.2 at baseline to 1.04 at 24 months. Sixty five percent of patients were dry at 2 years. Complications included erosion, migration and non-response to initial surgery. View the full abstract  The Adjustable Continence Therapy (ACT) System: One Year Results of the North America ACT Clinical Study Group. Franke E et.al. Abstract reported on 107 implanted patients with 12 months follow-up data. Mean provocative pad weight reduced from 49.7 grams at baseline to 11.9 grams at 12 months. IQoL improved from 36.0 at baseline to 70.5 at 12 months. Significant improvements were also observed in the UDI and IIQ scores. Device or procedure related adverse events were reported in 56.2% of subjects. 81% of these were considered to be of mild severity. View the full abstract
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| Hot Off the Press
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Two recent articles on ProACT have been published since the ProACTivities last newsletter, bringing the total number of articles published in international peer reviewed journals to eight, describing the clinical outcomes in close to 300 patients.
 Treatment of Postprostatectomy Stress Urinary Incontinence using a minimally invasive Adjustable Continence Balloon Device, ProACT: Results of a Preliminary Multicenter Pilot Study. Lebret T et.al. Urology 71 (2), 2008, 256-260. Report on a multicenter (7 institutions) pilot study with 62 implanted patients. Among the 44 patients who had RP without adjuvant radiotherapy, 89% improved (including 30% who became pad free). Of the 12 patients with adjuvant radiotherapy, 83% failed. Complications requiring removal occurred in 19 patients. Several other findings are reported that might result in lower complication or improved success rates (initial filling, how to deal with intra-operative perforations and where to place devices in TURP patients). The authors also confirm that there is a learning curve involved in this therapy. View the full abstractFor more information about the information in this article or to order reprints, contact Uromedica.  Implantation of an Adjustable Continence Therapy System Using Local Anesthesia in Patients with Post-Radical Prostatectomy Stress Urinary Incontinence: A Pilot Study. Gregori A. et.al. J Urol. Vol. 179, 192-1906, May 2008 [Epub ahead of print] Article reports on the feasibility of the ProACT system implantation using local anesthesia rather than general anesthesia or spinal block as currently recommended in product labeling. In addition the procedures were all done using trans rectal ultrasound (TRUS) guidance rather than the more common Fluoroscopy (X-Ray). View the full abstract |
| Expert Meeting Key Findings |
Twenty three of the leading ACT and ProACT implanters met on March 29 in Milan to discuss the following:  Dr. Peter Gilling (Tauranga, New Zealand) and Dr. Le-Mai Tu (Sherbrooke, Canada) provided an update to the group on the progress of the FDA studies which have now arrived in their final stages.  Dr. Ervin Kocjancic (Udine, Italy) and Dr. Andrea Gregori (Milan, Italy) debated the merits of fluoroscopy versus Transrectal Ultrasound guided ProACT implantation techniques a session which was chaired by Prof. Jørgen Nordling (Herlev, Denmark). Both imaging systems have benefits and there may be a benefit in using a combination, based on the type of patient and the experience of the physician. Dr. Giammo (Turin, Italy) presented his findings in a group of 20 patients treated with "Endoscopic Refilling Control". In this technique, the balloons are temporarily overfilled by an additional 2 cc at the end of the implant to assess urethral closure/sealing. Once verified, the balloons are deflated to 1cc. If this sealing is not demonstrated, the balloons are repositioned.  Prof. Von Heyden (Bad Friedrichshall, Germany) discussed his very positive experience with ACT in a very challenging group of female patients. Prof. Kröpfl (Essen, Germany) presented the results of his first 23 implanted male patients. Complete continence or substantial improvements was achieved in 70% of this group.  Dr. Hübner (Korneuburg, Austria) presented Uroflow data from a group of 55 patients implanted in 2004 (mean follow-up 24.6 months). Data suggested that there is no appreciable obstruction.  Dr. Heesakkers (Nijmegen, The Netherlands) led a session discussing the best approach if a patient implanted with ProACT has an elevated PSA and needs to be irradiated. The group was divided on whether it was best to deflate the balloons to approximately 1 cc and then reinflate after the course of treatment is completed or whether it was best to not do anything to the balloons. Further follow-up of patients involved will help to answer the question on what is the best approach. |
First Live Surgery Course at Luigi Sacco Hospital, Milan
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 On September 11 and 12, Prof. Gaboardi will host a course on the treatment of male urinary incontinence at the Luigi Sacco Hospital in Milan. While the course will review all potential treatments available, the focus will be on ProACT™. Prof. Jünemann (Kiel, Germany) will discuss Prevalence and Pathophysiology, Prof. Chartier-Kastler (Paris, France) will discuss the artificial urinary sphincter, answering the question whether this still is "the Gold Standard". Prof. Cruz (Oporto, Portugal) will review alternative surgical options such as male slings and bulking agents. Dr. Cook (Minneapolis, USA) will present a historical overview about the development of the ProACT system. Dr. Romano will review the published clinical results on ProACT. Dr Hübner (Korneuburg, Austria) discusses the evolution of the ProACT implant technique. Dr. Gregori (Milan, Italy) will discuss the benefits of using ultrasound imaging when implanting. John Engstrom (Minneapolis, USA) will discuss his experience as a patient. At the end of the 11th, Dr. Kocjancic (Udine, Italy) will discuss possible future indications of the Adjustable Continence Therapy. Dr. Gregori will discuss postoperative management and management of suboptimal results. On the morning of the 12th, a number of live surgeries will be performed by Dr. Huebner and Dr. Gregori). If you are interested in attending this course, please contact: The Office Srl Via San Nicolό 14 34121 Triseste Phone: +39 040 368343 Fax: 39 040 368808 Website
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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 ProACT 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 ProACT 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 ProACT 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 ProACT 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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