 In this fifth issue of ProACTivities you will find a brief review of the relevant parts of the International Consultation on Incontinence (held in Paris July 5-8) as well as a preview of the ICS in Cairo (October 20-24). The evidence base for the Adjustable Continence Therapy continues to expand with an article by Dr. Peter Gilling (Tauranga, New Zealand) on his two-year experience with ProACT and articles by Dr. Ervin Kocjancic and Dr. Johann Wachter on ACT® in recurrent SUI in women. All articles are excerpted in this issue. We also provide an answer to the often asked question about MRI scans and the Adjustable Continence Therapy devices.
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ICS Preview
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The 2008 Annual Meeting of the International Continence Society will be held this year in Cairo. As usual, this meeting should have many sessions of interest for physicians interested in ProACT and ACT. Surgical Management of Stress Urinary Incontinence in Men
Monday, 20 October, 2008, 09:00 - 12:00 Educational Course #2 Chair: Ajay Singla, USA Speaker on ProACT: Ervin Kocjancic, Italy Practical Aspects of Bulking Agents in the Treatment of Pelvic Floor DysfunctionMonday, 20 October, 2008, 14:00 - 17:00 Workshop #26 Chair: Sherif Mourad, Egypt Speaker on ACT: Emmanuel Chartier-Kastler, France Innovation in the Treatment of Male Urinary IncontinenceTuesday, 21 October, 2008, 14:00 - 17:00 Workshop #37 Chair: Carlos Arturo Levi D'Ancona, Brazil The following abstracts will also be presented:Male Incontinence and Voiding DysfunctionWednesday, 22 October, 2008, 14:00-15:30 Session 3 (poster) Hall A.  Poster # 20 Continence without obstruction- A long term evaluation of the Adjustable Continence Therapy (ProACT™) Huber E et al.
Non-Discussion Posters # 255 International Multi-centre evaluation of the Adjustable Continence Therapy (ProACT™) for Male Post Prostatectomy Stress Urinary Incontinence. Kocjancic E. et al. # 259 Transrectal ultrasound guided ProACT system implantation under local anesthesia in patients with post-radical prostatectomy stress urinary incontinence: evaluation of objective pain, subjective discomfort and patient satisfaction. Gregori A. et al.  # 483 One year results of the Adjustable Continence Therapy (ACT®) System in the North America ACT® Clinical Study Group. Carmel M. et al. # 525 The Adjustable Continence Therapy for the Treatment of Recurrent Female Urodynamic Stress Urinary Incontinence - 4 year results. Kocjancic E. et al. |
| Hot Off the Press
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During the last few months several additional articles were published on ACT, as well as ProACT. The bibliography now contains close to 20 articles.
ACT for Recurrent Stress Urinary Incontinence in Women
After the initial euphoria about the results of the slings in women with stress incontinence, more physicians have become aware that 15-20% of these patients will not be satisfied with the clinical outcome of their sling procedure. This awareness has resulted in an increase in the use of ACT in this patient group. This use is reflected in the two articles that were published in July and August.
Adjustable Continence Therapy for Treatment of Recurrent Female Urinary Incontinence. Kocjancic E. et al. Journal of Endourology, Vol. 22, Number 7, July 2008.
Forty-nine patients were implanted. One year follow-up data was available on 38 of these patients and four-year data is available on 23 patients. All patients had undergone prior procedures to treat their SUI. At 12 months 68% of patients reported being dry and a further 16% reported improvement while the remaining 16% of patients were unchanged. Comparable improvements were seen in pad usage and I-QoL. Eleven patients required removal of the device and all were re-implanted and had 12 month data. Complications included migration (12%), balloon failure (3.6%), and erosion (4%). The ACT device provided significant improvement in at least 70% of patients with recurrent stress urinary incontinence.
View the full abstract
For more information about the information in this article or to order reprints, contact Uromedica.
Adjustable Continence Therapy for Female Urinary Incontinence: A Minimally Invasive Option for the Difficult Case. Wachter J et al. Urologia Internationalis Vol. 81, No. 2, August 2008
Forty-one patients of a mixed etiology and with a mean age of 73, all suffering from SUI, were implanted with ACT and followed for a mean of 25 months. Overall 44% of the women became fully continent and another 15% reported a significant improvement. The overall success rate in this series was 59%. In the opinion of the authors, this is acceptable given the diverse characteristics of the study population. ACT related complications occurred in 16 (39%) patients, including balloon migration, transient urinary obstruction and balloon leakage. The authors conclude that ACT appears to be an attractive minimally invasive surgical treatment for women with complicated UI.
View the full abstract
For more information about the information in this article or to order reprints, contact Uromedica.
Long Term Efficacy of ProACT
 An adjustable continence therapy device for treating incontinence after prostatectomy: a minimum 2-year follow-up. Gilling P et al. BJUI, Published Online: 28 Jun 2008. Thirty seven patients were implanted with the ProACT device (30 incontinent after radical prostatectomy and seven after holmium laser enucleation of the prostate). At 24 months, 62% of 34 men were pad-free and 81% required one pad or less. Five patients had to be explanted, two for balloon migration (the two very first patients) and three for infection (possibly due to poor adjustment technique after surgery). View the full abstract For more information about the information in this article or to order reprints, contact Uromedica. |
| ICI Committee on Male Incontinence Discusses ProACT |
700 Urologists, urogynecologists and allied health care professionals met in Paris in early July to review and comment on the work of 22 ICI committees who had reviewed the 2005 guidelines and updated these based on published evidence.
The International Consultation on Incontinence (ICI) is a meeting of key opinion leaders that meets every three years to provide evidence based guidelines on various aspects of incontinence. During the previous meeting (2005), there was no mention of ProACT as a therapy for the treatment of male incontinence. This year was quite different. Prof. Sender Herschorn (Toronto, Canada), Chairman of the Committee on Male incontinence, reviewed most of the available articles and mentioned the promise of the therapy. Some concerns were voiced about the rate of complications in this patient group. (Hübner, BJUI 2005). These complication rates however, applied predominantly to the earliest group of patients who were treated. Since the first published article, significantly better results have been reported due to improvements in surgical technique, device design and instruments. (Hübner, European Urology 2006 and subsequent articles by other authors.)
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| First Live Surgery Course in Milan |
ProACT; Implantation Technique Options
September 11-12, 2008 - Approximately 45 urologists from Europe, Canada and Egypt met at the Luigi Sacco Hospital in Milan to attend this course on the implantation technique options for ProACT. A variety of topics were presented and three live implants were performed during this course.
Prof. Gaboardi, Chairman of the Urology Department, introduced the course followed by Prof. Jünemann (Kiel) who discussed the pathophysiology and the idea that the prevalence of post radical prostatectomy incontinence is more prevalent than often assumed. Prof. Chartier-Kastler (Paris) discussed the Artificial Urinary Sphincter and Dr. Guimaraes (Oporto) discussed alternative therapies including injectables and the various slings. Dr. Hübner (Vienna), the first surgeon to implant ProACT in men, discussed his experience. Dr Romano (Milan) reviewed the published literature on ProACT which includes approximately ten articles in peer reviewed journals. Dr. Kocjancic (Udine) described his experience with ACT in the female population as well as several other patient categories. Tim Cook (Uromedica President) presented an evaluation of the ProACT devices and technique. Dr. Gregori described the ultrasound technique and noted various trouble shooting techniques. John Engstrom, who had initially tried a transobturator sling, provided the perspective of the patient. The next day, three live implants were performed: one highlighted the traditional fluoroscopically guided technique (Hübner) and two implants with the TRUS guided technique (Gregori).
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ProACT Case Study Available
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Uromedica has prepared its first case study. This study describes the experience of John, a 62-year-old school administrator who has been incontinent since a prostatectomy in 2005. He experienced no improvement after the implantation of a transobturator male sling. John traveled to Milan in November of 2007 and had the ProACT™ system implanted by Dr. Andrea Gregori at Luigi Sacco University Hospital. The procedure was done under Transrectal Ultrasound (TRUS) guidance; this also helped in visualizing the male sling which resulted in a slightly different placement of the balloons. Six months after the procedure, John has reduced pad usage from 5-7 pads per day before the implant to 1-2 pads per day currently. He has resumed his daily activities, which includes running 10 kilometers per day and he is very pleased with the outcome. Read the whole case study or order a copy.
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| Adjustable Continence Therapy Compatibility with MRI
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Are ACT and ProACT devices MRI-compatible? Our devices have been tested in compliance with ASTM designation F2052-06 (Standard test for measurement of magnetically induced displacement field interactions, heating, and artifacts at 3-Tesla). The devices will not present an additional risk or hazard to a patient undergoing an MRI procedure with the scanning operating with a static magnetic field of 3 Tesla or less for 15 minutes at whole body Specific Absorption Rate (SAR) of 3w/kg. Device artifacts may present problems if the image area is in or near the area where the device is located.
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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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