AbbeyMoor receives approval for design improvements to ‘The Spanner’ prostatic stent

AbbeyMoor Medical Inc., a developer and manufacturer of medical devices for the management and treatment of prostatic obstruction, announced today that it has received PMA approval from the US Food and Drug Administration (FDA) for design changes to their flagship product, The Spanner Prostatic Stent.

"These changes are aimed at further improving patient comfort over the current highly accepted levels," said Darren Cook, director of marketing with the company. "Our goal is to hear an even greater percentage of our patient's state that they are not aware of the device's presence." According to Mark Whalen, VP of product development with the company, "The approved changes to the device result in a significant increase in flexibility over the current Spanner design with no impact to the ease of delivery and removal of the device."



The Spanner is a temporary prostatic stent designed to aid men who are experiencing difficulty in urination due to prostatic obstruction. Device placement can be performed in a physician office and does not require cystoscopy or anesthesia for placement. The Spanner is an alternative to indwelling catheterization, intermittent catheterization, or the use of a suprapubic tube in some patients.

The Spanner temporary prostatic stent has been designed to open the prostatic urethra and allow patients to maintain urine flow and allow volitional voiding by reducing urethral resistance within the prostate. As shown in the figure to the right the Spanner has a proximal balloon which is seated in the bladder neck to properly position the stent in the prostatic urethra. The stent extends from the bladder to just above the external sphincter. Device tethers (suture material) traverse the external sphincter to allow normal sphincter function, thus providing patients the ability to volitionally void. The distal anchor of the device is positioned in the bulbar urethra, just below the sphincter, to prevent device movement and migration into the bladder.

The Spanner Prostatic Stent

Evaluation of treatments for benign prostatic enlargement

Research published by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme has found that transurethral resection, the most common operation for benign prostatic enlargement (BPE), remains a clinically and cost-effective treatment. BPE commonly causes older men to have difficulty passing urine and may require surgery to alleviate the problem.

Researchers at the University of Aberdeen, led by Professor James N'Dow, examined existing data to determine the risk factors and clinical and cost-effectiveness of less minimally invasive treatments for BPE compared to the current standard of transurethral resection. These included 'tissue ablative' treatments such as holmium laser enucleation of prostate (HoLEP); transurethral vaporisation; and 'minimally invasive' techniques such as laser coagulation, microwave therapy and transurethral needle ablation. They also looked at the overall long term benefits to patients.

Methods similar to transurethral resection require an anaesthetic, stay in hospital, and can sometimes lead to unwanted side effects such as bleeding. However, some patients do not require general anaesthetic and treatment can be performed within an out patient department using alternative procedures. Newer procedures have been developed but there is uncertainty about their clinical and cost-effectiveness.

The research team concluded that transurethral resection provides a consistent, high level of long-term symptom improvement. Improvements in quality of life and urinary flow were also observed. The risks associated with the minimally invasive interventions were generally lower than transurethral resection, with fewer adverse events, such as the need for a blood transfusion. However, the need for repeat surgery was more common with the newer technologies, especially the minimally invasive interventions. The evidence also suggests that HoLEP could offer some advantage over transurethral resection (such as equally good urine flow but shorter hospital stay and reduced bleeding) although long-term follow-up data is needed.

Professor James N'Dow said, "Overall our findings do not support a change in surgical treatment of BPE and suggests that TURP should remain the standard approach. Which minimally invasive intervention is most promising is unclear and good quality randomised controlled trials are needed to prove whether they are superior. Until then personal preference will influence choice of procedure with some patients choosing minimally invasive treatment options for their decreased morbidity.

To view full details about the project visit www.hta.ac.uk/1468 and the report is also published in the BMJ.

http://www.hta.ac.uk

Relationship between prostate information and lower urinary-tract symptoms evident

In the December issue of European Urology (http://www.elsevier.com/locate/eururo) Dr. Curtis Nickel and associates report on the evidence of a relationship between prostate inflammation and lower urinary tract symptoms (LUTS) in men enrolled in the REDUCE trial.

The REDUCE (Reduction by DUtasteride of prostate Cancer Events) trial is a 4-year, phase-III placebo-controlled study that evaluates whether the drug dutasteride decreases the risk of biopsy-detectable prostate cancer. Dutasteride is a 5-alpha-reductase inhibitor, a drug that inhibits the conversion of testosterone into dihydrotestosterone (DHT), a hormone that may cause benign prostatic obstruction. The trial involves men with a negative prostate biopsy. The men were given either dutasteride or a placebo and followed for 4 years.

According to Dr Curtis Nickel, the lead researcher in the trial: "The data from the entrance biopsy have enabled additional investigations to be made, including examination of the relationship between prostate inflammation and LUTS."

The study is remarkable for its scope, which includes data on 8,224 men. A majority of participants had chronic inflammation at baseline. Total IPSS (International Prostate Symptom Score; the most widely used gauge of lower urinary tract symptoms associated with an enlarging prostate) and subscores were higher in the group of patients with chronic inflammation at baseline compared to those with no chronic inflammation. The differences were small but statistically significant. A regression analysis was performed. It revealed that higher values of age and average chronic inflammation were significantly associated with higher IPSS scores.

According to Dr Nickel, "The study entry criteria that selected older men and decreased enrollment of men with a greater degree of inflammation and LUTS may have limited the strength of the relationship between the degree of chronic inflammation and LUTS. It may actually be stronger."

The impact of baseline prostate inflammation on the progression of LUTS and/or associated complications will be determined during a 4-year follow-up study.

Elsevier

Saw Palmetto for enlarged prostate

Physician-scientists are studying an herbal supplement that might aid in reducing the symptoms of an enlarged prostate in men. Recent figures show that benign prostatic hyperplasia (BPH) occurs in an estimated 50 percent of men over the age of 50 and in 75 percent of men 80 and older.

The research team, led by Dr. Steven A. Kaplan, professor of urology at Weill Cornell Medical College and attending urologist at NewYork-Presbyterian Hospital/Weill Cornell, will study the affects of using saw palmetto extract compared to a placebo, with the hope of reducing the symptoms of BPH. Symptoms include difficulty starting a urine stream (hesitancy and straining), decreased strength of the urine stream (weak flow), feeling that the bladder is not completely empty, an urge to urinate again soon after urinating and pain during urination (dysuria).

It is theorized that compounds called phytoesterols, found in saw palmetto, might prevent prostate enlargement. Experts believe that prostate swelling may be caused by a rise in dihydrotestosterone (DHT) -- a testosterone derivative involved in prostate growth -- over a male's lifespan, especially during middle age. Scientists are unclear as to what causes the hormone to rise with time. However, escalating estrogen within the body has been correlated with, but has not been proven to be, directly promoting BPH. Like a basketball player blocking a shot from going into a basket, phytoesterols in saw palmetto might block natural estrogen from binding to receptors in the body.

Weill Cornell Medical College

Enlarged prostates: The choice of treatment needs careful consideration

In the last few years, the treatment options for prostate problems have expanded. The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed new treatments and warns that some new surgical techniques are being heavily promoted without first having been adequately evaluated.

Informed choices are essential

For many men, the symptoms of this condition are just annoying. But for some men, an enlarged prostate means going to the toilet so often that a good night's sleep has become a thing of the past. Most of the time the cause is an enlarged prostate, a condition doctors call "benign prostatic hyperplasia". One in five men in their 50s are affected - and the majority of men in their 70s will have symptoms.

The treatment choices have greatly expanded in recent years. However IQWiG's evaluation of the research raises questions about many surgical techniques. According to the Institute's Director, Professor Peter Sawicki, "Not everything that is new is necessarily an improvement. Better information is necessary to help men and their doctors weigh up the advantages and disadvantages of the various treatments."

To that end, IQWiG has published easy-to-understand summaries of the research in this area on IQWiG's website for the public, www.informedhealthonline.org. Included is information on managing prostate symptoms, medicines and surgical options as well as the stories of men who have used different treatments.

Most men with BPH symptoms will never need surgery

According to researchers' best estimates, about 3 out of every 10 men in Europe will handle their prostate symptoms without medication or surgery and perhaps only 1 in 10 will have surgery. The rest will use medications, including herbal medicines, if their symptoms become too troublesome.

"In Germany and other European countries, drugs called alpha blockers have taken over as the most common treatment choice for benign prostatic hyperplasia," said Professor Sawicki. "These drugs were originally developed to reduce high blood pressure, but prostate symptoms will also improve at least a little for 60% of the men who use them."

In analysing the research results for surgery, the Institute concluded that the original surgical procedures still have the best results. A few of the new surgical techniques appear to have good results - for example, possibly shortening the time needed in hospital. But more research is needed to confirm this. And most of the new techniques use equipment that has not yet been tested in enough trials.

"Prostate surgery can be very effective, but the adverse effects are a major concern for many men. Some of the newer techniques might have fewer adverse effects, but they may be so much less effective that the symptoms return, as bad as ever, within a couple of years," Professor Sawicki said.

Institute for Quality and Efficiency in Health Care

Prostate Health: More Than Just Prostate Cancer

Prostate cancer isn’t the only condition of which to be aware this Prostate Health Month, according to expert urologists from the American Urological Association. One extremely common non-cancerous condition, particularly in older men, is benign prostatic hyperplasia (BPH). In fact, BPH affects half of all men between the ages of 51 and 60, and can affect up to 90 percent of men over the age of 80.

The major symptoms of BPH, including frequent urination, urinating several times at night or difficulty urinating (weak stream, dribbling or the need to push or strain) may seem to be a normal part of aging. However, these symptoms are treatable and, if ignored, can lead to life-threatening complications. In the majority of men, BPH is a progressive disease. It can lead to bladder damage, infection, blood in the urine, and even kidney damage if left untreated. A man should see a doctor immediately if he has: blood in the urine, pain with urination, burning with urination or is unable to urinate.

Several treatment options are available for men with BPH. Patients should speak to their doctors in order to determine which treatment option is most appropriate for them. Treatments include watchful waiting, medications, the insertion of prostatic stents to open the urethra, or minimally invasive surgical therapies. Don’t suffer in silence: seek expert medical advice.

During this important month and throughout the year, the AUA can provide information, statistics and expert commentary on subjects related to prostate health. The AUA can assist in developing related story topics on prostate health, such as:

• What is BPH/enlarged prostate? How is it treated?
• What is prostatitis? How is it treated?
• Robot-assisted prostatectomy - the latest technology
• New techniques and technology to treat prostate cancer
• When should men have a prostate-specific antigen (PSA) test to screen for prostate cancer?
• What is active surveillance and when is it appropriate?
• Treatment options for prostate cancer and what patients should know about each

Please contact Lacey Holt at 410-689-4054 to schedule an interview with one of the following experts:

• Christopher Amling, MD, Professor and Director, Division of Urology, University of Alabama at Birmingham.
• J. Brantley Thrasher, MD, FACS, Professor and William L. Valk Chair, Department of Urology and the Co-Director of Operative Services at the University of Kansas Medical Center in Kansas City, KS.

For more information on common prostate conditions or to find a urologist or a free or low-cost prostate cancer screening near you, please visit http://www.UrologyHealth.org.

American Urological Association

A Strategic Plan for Research into Benign Prostate Disease

For the first time, a strategic plan for research into benign prostate disease, based on the latest scientific knowledge, has been published by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH). The NIDDK Prostate Research Strategic Plan is the culmination of discussions and meetings among experts over the past two years in an effort to outline a strategic vision for research into these elusive and multi-faceted diseases.

"The NIDDK Prostate Research Strategic Plan reflects NIH's commitment to advancing translational research by facilitating planning efforts among basic scientists, clinicians, advocacy groups, and patients," said NIDDK Director Griffin P. Rodgers, M.D. "The educational summaries in each section of the plan provide clear explanations of the scientific data and the reasoning behind each of the recommended research priorities."

The research area of benign prostate disease includes two of the most significant non-cancerous disorders affecting males - benign prostatic hyperplasia (BPH) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). BPH, an enlargement of the prostate gland, is often associated with lower urinary tract symptoms (LUTS). LUTS, which can include symptoms such as overactive bladder, restricted or excessive urination, and sensations of urgency, affects men of all races and ethnic groups and can become severe over time. An estimated 50 percent of men in their 50s have BPH and 26 to 46 percent of men between the ages of 40 and 79 have moderate to severe symptoms. CP/CPPS is generally described as inflammation of the prostate gland. There is no detectable bacterial basis, but CP/CPPS sometimes is associated with urinary symptoms, pain, and sexual dysfunction. The source of the pain in this syndrome is unknown and there are no generally effective methods for preventing or treating the condition.

The NIDDK Prostate Research Strategic Plan addresses the four major research areas judged critical for advancing the field. These include basic science, epidemiology and population-based studies, translational research, and clinical sciences. Recommendations from the plan include:

* Promote interdisciplinary research that focuses on how benign prostate diseases are influenced by other organ-specific diseases and systemic conditions, such as obesity, high blood pressure, high cholesterol, cardiovascular disease, diabetes, and erectile dysfunction. For example, the possible influence of high blood pressure on BPH/LUTS is a previously unexplored area of research.
* Study the primary prevention of benign prostate diseases, including possible benefits of lifestyle changes such as avoidance of alcohol and caffeine, frequency of sexual practice, pelvic massage therapy, stress reduction, and diet modulation for relief of CP/CPPS.
* Develop data and human tissue resources from patients of various ages to derive information useful in investigating risk factors, underlying causes and natural history of disease progression, quality of life, quality of care, and decision making regarding treatment of benign prostate disease. Develop imaging approaches and other biomarker studies to assess severity and risk of progression based on physical and cellular findings.
* Develop targeted medical therapies based on new insights into disease-relevant cellular pathways and physiological events.
* Develop standardized, clinically significant benign prostate disease syndrome definitions and classifications based on measurable phenotypic features.
* Train and mentor epidemiologists, health services researchers, clinical investigators, and students interested in the study of benign prostate disease.

"The long-standing, unanswered questions about the causes of these disorders prompted the NIDDK to examine the state of the science and to develop a new vision for future research," explained Chris Mullins, Ph.D., NIDDK's director of basic cell biology programs in urologic and kidney disease. "As part of this process we convened the Prostate Research Planning Committee, composed of clinical and basic scientists and epidemiologists from around the country, to review and evaluate past and current research and to make individual recommendations for new research priorities. The NIDDK Prostate Research Strategic Plan is the result of that collaborative effort."

The plan is designed to be read by a broad audience of researchers, clinicians, advocacy groups, representatives of funding organizations, and patients. Each major section includes a mission statement, a lay summary, an overview of current knowledge, and high-priority recommendations for future research. The plan is online at http://www2.niddk.nih.gov/NR/rdonlyres/318606D2-A9D1-4CAD-B9BF-8EB3009C83BE/0/NIDDKProstateStrategicPlan.pdf and can be purchased online in print or compact disc format at http://catalog.niddk.nih.gov/PubType.cfm?Type=182&CH=NKUDIC.

NIDDK conducts and supports research in diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic, and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe, and disabling conditions affecting Americans. For more information about NIDDK and its programs, see www.niddk.nih.gov.

The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

National Institutes of Health

Botox can help men with enlarged prostates

Injecting botulinum toxin A, or Botox, into the prostate gland of men with enlarged prostate, eased symptoms and improved quality of life up to a year after the procedure, according to a study by researchers at the Chang Gung University Medical College, Taiwan, and the University of Pittsburgh School of Medicine. The study, based on 37 men with benign prostatic hyperplasia (BPH), will be presented at the annual meeting of the American Urological Association (AUA) in Anaheim, Calif. and published in Abstract 1837 in the AUA proceedings.

"Millions of men in the United States suffer from enlarged prostate," said Michael B. Chancellor, M.D., senior author of the study and professor of urology and gynecology at the University of Pittsburgh School of Medicine. "It's a challenging disease to live with because it causes frequent and difficult urination. Unfortunately, common treatments also are problematic because they carry some risk of serious side effects, such as impotence. Our results are encouraging because they indicate that Botox could represent a simple, safe and effective treatment for enlarged prostate that has long-term benefits."

The study participants, previously diagnosed with symptomatic BPH that did not respond to standard medical treatment, received injections of Botox directly into their prostate glands. Up to one year post injection, 27 of these patients, or 73 percent, experienced a 30 percent improvement in urinary tract symptoms and quality of life. Patients did not experience any significant side effects, including stress urinary incontinence or erectile dysfunction.

According to Yao-Chi Chuang, M.D., principal investigator of the study from Chang Gung University Medical College, Taiwan, Botox reduces the size of the prostate gland through a cellular process called apoptosis, in which the prostate cells die in a programmed manner. This reduction in size can improve urine flow and decrease residual urine left in the bladder.

BPH is one of the most common diseases affecting men as they age. More than half of all men over the age of 60 and 80 percent by age 80, will have enlarged prostates. Forty to 50 percent will develop symptoms, which include more frequent urination, urinary tract infections, the inability to completely empty the bladder and, in severe cases, eventual damage to the bladder and kidneys.

University of Pittsburgh