Archive | Bladder Health

Nebraska Hospital Uses Team Approach to Reduce UTIs in Rehab Patients

In a 300-bed Nebraska rehabilitation hospital, nurses, occupational and physical therapists, case managers and education staff have successfully implemented a team approach to dramatically reduce infections from urinary catheters, the most common type of infection contracted from healthcare settings.

According to an abstract presented at the 38th Annual Educational Conference and International Meeting of the Association for Professionals in Infection Control and Epidemiology (APIC), the team reduced catheter associated urinary tract infections (CAUTIs) by 89 percent over a 14-month period.

The team worked to decrease the use of catheters, which are a known risk factor for UTIs, discontinuing their use unless medically necessary.  In cases where urinary catheters were necessary, the team educated nursing staff, family members and patients on proper care to reduce the chance of infection.  The team was led by infection preventionist Kristina Felix, BA, RN, CRRN, CIC.

When the project started in February 2010, the CAUTI prevalence rate was 36.6 percent but dropped to 6.6 percent three months later.  The original pilot concluded in April 2011.  The team identified reasons for catheter use when medical necessity was in question.  These factors included patients admitted to rehabilitation settings from acute care facilities with catheters in place, and patients whose families viewed catheters as a more convenient way to manage incontinence.

This task force improved bladder management protocols and standards, balancing the medical requirements of the patient with the need for patients to be infection-free, continually re-assessing the appropriateness for each catheter.

Felix estimates that this program prevented up to thirty UTIs each month and saved the facility about $1,000 per infection avoided.  No additional costs were associated with implementing these interventions.

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Botox Approved in Ireland for Treatment of Urinary Incontinence

The Irish Medicines Board has approved Botulinum toxin type A to treat urinary incontinence management in adults with neurogenic detrusor overactivity (NDO).

Neurogenic detrusor overactivity results from nuerogenic bladder due to multiple sclerosis or stable sub-cervical spinal cord injury.

Allergan Inc. has said that this step is important in securing national licenses in fourteen European countries that are involved in the Mutual Recognition Procedure.  The positive opinion came after the Irish regulatory agency evaluated Allergan’s successful global Phase III program.

Bladder dysfunction affects approximately 60 percent to 80 percent of people with multiple sclerosis (MS) and 75 percent to 80 percent of those with spinal cord injury (SCI), including urinary incontinence.

Both MS and SCI patients often have bladders which contract during the filling stage, during which time they should be relaxed.  This condition is known as neurogenic detrusor overactivity, which can result in uncontrolled urinary leakage, known as urinary incontinence.

When Botox is injected into the bladder muscle, the involuntary contractions subside and bladder activity increases, resulting in fewer urinary leaking incidents.  Sometimes the problem is completely resolved.

Urinary incontinence can often be a socially isolating and disabling condition. People who suffer from it frequently experience low self esteem, loss of independence, embarrassment, and depression.   MS and SCI patients with urinary incontinence are also more likely to develop skin irritations and ulcers, recurrent and kidney failure.

Douglas Ingram, President of Allergan in Europe, Africa and the Middle East, said that Allergan was pleased about the Irish Medicines Board’s decision.

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Study Finds Strong Association Between Smoking and Risk for Bladder Cancer

Data from a large cohort study showed that smoking’s contribution to bladder cancer risk increased over the past 25 years, and the attributable risk in women caught up with that of men.

Current smokers increased risk of bladder cancer by four times compared to people who never smoked.  The risk among former smokers two times that of people who never smoked.  Previous cohort studies had shown about a threefold increased risk of bladder cancer among current smokers.

According to a recent article published in JAMA, smoking accounted for about half of the population-attributable risk of bladder cancer in men and women alike.

This apparent association between smoking and bladder cancer could reflect changes in cigarette manufacturing.

From the 1980s, the rates of bladder cancer in the U.S. has remained stable, ranging from 123.8 to 142.2 cases per 100,000 person-years in men, and from 32.5 to 33.2 cases per 100,000 person-years in women.

The authors noted in their introduction that the prevalence of smoking and cigarette composition have changed considerably during the same period, which perhaps changes the nature of the association between smoking and bladder cancer.

Neal D. Freedman, PhD, of the National Cancer Institute in Bethesda, Md., and co-authors revisited risk estimates for smoking and bladder cancer by examining data from the National Institutes of Health-American Association of Retired Persons (NIH-AARP) Diet and Health Study.

The NIH-AARP cohort study had follow-up data through December 31, 2006.  The participants, who were ages 50 to 71 at enrollment, completed a lifestyle questionnaire during 1995 and 1996.  This follow-up continued until the end of the study, a diagnosis of bladder cancer, a move outside the study’s catchment area, or death.

State cancer registries provided bladder cancer diagnoses information.  The foma; analysis included 281,394 men and 186,134 women.  During 4,518,941 person-years of follow up, 3,896 men had new diagnoses of bladder cancer, resulting in an incidence of 144 per 100,000 person-years.  During this same follow-up period, 627 women had a new diagnosis of bladder cancer for an incidence of 34.5 per 100,000 person-years.  Rates among people who never smoked were 69.8 and 16.1 per 100,000 person-years in men and women, respectively.  These rates increased to 154.6 and 276.4 per 100,000 person-years among men who were former or current smokers. Corresponding rates in women were 40.7 and 73.6 per 100,000 person-years.

The research team performed a systematic review and meta-analysis of prospective cohort studies of current smoking and bladder cancer started between 1963 and 1987.

Limitations of the study included lack of information on the year smoking had started and lack of follow-up data on smoking after the baseline survey to know how many people may have quit.

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Stem Cell Injections Better than Collagen Injections in Treating Stress Urinary Incontinence

A new study from Austria has found that injections of stem cells and other cells obtained from a woman’s own body can treat stress urinary incontinence with dramatically better results than conventional collagen injections.

These results mimic those from U.S. research that is underway and might also be long-lasting.

The study appears in The Lancet. The Austrian researchers, led by Hannes Strasser, MD, from the Medical University of Innsbruck, compared the effects of the stem cell injections with conventional injections of collagen in 63 women with stress urinary incontinence.

The team first performed a small muscle biopsy on the upper arms of the 42 women assigned to get stem cell injections.  In the laboratory, the women received myoblasts, a type of muscle stem cell, and fibroblasts, cells which form the structural framework for many body tissues.  According to Strasser, both types of cells have been shown to be effective in reconstructing the lower urinary tract in animal studies.

Then, Strasser’s team injected the cells back into the women’s sphincter and surrounding area using the ultrasound.

Traditional collagen injections, which do not generally have a high success rate for incontinence, were given to the other 21 women. Collagen treatments work by bulking up the area to compress the urethra, helping to hold urine.

After 12 months, 38 of the 42 women given the stem cell and other cell injections were completely continent. The other four showed either slight or substantial improvement. Only two of the 21 who got collagen injections were continent; seven others showed either slight or substantial improvement.

From ultrasound exams after the injections, it could be seen that the thickness of the sphincter had increased 59 percent in the women given cell injections but just nine percent in the collagen-treated group.  Muscle contractibility increased much more in the cell group.  Increases in the sphincter thickness and muscle contractibility are thought to help improve symptoms.  The women who were treated with the injections of cells reported higher quality of life than the women treated with collagen.  No one in the study reported any adverse side effects.

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Sacral Neuromodulation Treats Refractory Idiopathic Urge Urinary Incontinence

According to Dutch researchers, sacral neuromodulation could be a safe, if impermanent, way to treat refractory idiopathic urge urinary incontinence.

Sacral neuromodulation, also known as sacral nerve stimulation, involves the implantation of a programmable stimulator subcutaneously which delivers low amplitude electrical stimulation through a lead to the sacral nerve, usually accessed via the S3 forament.

In a new study published in a recent issue of the Journal of Urology, Jan Groen, Ph.D., Bertil F.M. Blok, M.D., Ph.D., and J.L.H. Ruud Bosch, M.D., all from the Erasmus Medical Center in Rotterdam and University Medical Center Utrecht (JLHRB), Utrecht, The Netherlands, report on 60 women who had leads for sacral neuromodulation implanted by open surgery.

Eighty-seven percent of the women had at least a 50 percent decrease in incontinence episodes or the number of pads used daily at one month.

By five years, however, only 62 percent of the women were still reporting at least a 50 percent decrease from baseline.  Additionally, only 15 percent were completely continent.  Over half (32 patients) had 57 adverse events; most involved hardware or pain and discomfort. None were serious.

The study’s lead author Groen said that despite its decreasing effectiveness, neuromodulation “remains our first choice, especially in younger patients, as the technique is safe, does not need frequent re-treatment and is not accompanied by a possible need for self-catheterization.”

He does, however, acknowledge that the relative place of neuromodulation in the treatment algorithm and the role of its most important alternative option, botulinum toxin, are evolving.

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C-choline Offers No Advantage for Bladder Cancer Scans

Israeli researchers have recently reported that using C-choline as a tracer in positron emission tomography/computerized tomography (PET/CT) for staging urothelial carcinoma offers no advantages over fluorine-18 2-flouro-2-deoxy-D-glucose (F18-FDG).  In fact, C-choline may perform worse.

Shay Golan, MD, of Rabin Medical Center found that despite initial optimism, the use of the novel trace C-choline in PET/CT did not improve the detection of extravesical transitional cell carcinoma, compared with F-18 FDG.  FDG had a tendency toward an improved accuracy.  These results were published in the Journal of Urology.

Dr. Golan, Petah Tikva, and colleagues found that for bladder cancer staging FDG PET/CT has not shown a clear advantage over contrast CT, which may be due to urinary excretion of FDG masking the uptake.

Initial studies supported the view that because C-choline has negligible excretion into the urinary system, this would make it a potentially better metabolic marker.  To investigate this hypothesis, the research team used both methods to evaluate local and metastatic disease in 20 patients with bladder cancer.  Fifty-one lesions showed abnormal tracer activity.  C-choline had a positive predictive value of 84.7% for all detected lesions. For FDG, the proportion was 90.7%. Corresponding values for extravesical lesions were 79.4% and 88.2%.  There were discrepant findings at eleven sites and FDG found four lymph nodes metastases that were missed using C-choline.  Nevertheless, bladder tumor involvement was unrecognized by FDG in three cases in which C-choline clearly showed increased uptake.

The research team concluded that despite the limitations of their preliminary study, they found that the diagnostic performance of PET/CT in the detection of metastatic urothelial carcinoma was not improved when C-choline was used as the tracer.

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Survival Chances Not Affected by Chemotherapy Before or After Bladder Cancer Surgery

According to a report in the peer-reviewed journal Cancer, in advanced bladder cancer, receiving chemotherapy before or after surgery does not affect survival, as long as it is given perioperatively.

Lead author James M. McKierman, MD, said that there is no clear cut randomized data to suggest that chemotherapy is better to give before or after surgery.  With his colleagues at Columbia University Medical Center, McKierman reviewed data on 146 patients who received multiagent platinum-based systemic chemotherapy for locally advanced bladder cancer between 1988 and 2009. Half of them received neoadjuvant chemotherapy, and the other half was treated postoperatively.

The team found no significant difference in overall or disease-specific survival between groups in the 122 patients treated with cisplatin-based protocols.  The median survival with neoadjuvant versus adjuvant therapy was 11 months versus 12.5 months, respectively.    This was also true when patients received methotrexate/vinblastine/adriamycin/cisplatin (median survival, 16 months versus 22.2 months).  Additionally, there was no significant difference between neoadjuvant and adjuvant cisplatin- or carboplatin-based chemotherapy.

There was, however, a significant difference observed in the 43 patients who received gemcitabine/cisplatin.  Postoperative treatment for this group was associated with a significantly reduced survival.  The team calls for further studies to clarify this finding, but they emphasize that these patients probably had worse pre-chemotherapy characteristics, including decreased performance status.

The study concluded there were no significant differences overall in survival between patients treated with chemotherapy before or after radical cystectomy.  Dr. McKiernan that this finding should be “considered when counseling patients regarding the sequence of perioperative chemotherapy and should be validated with a prospective randomized trial.”

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Tests for Overactive Bladder Drugs Produce Mixed Results

A randomized placebo-controlled trial showed that overactive bladder (OAB) symptoms decreased significantly within four weeks after the start of treatment with the investigational beta-3 agonist mirabegron.  Frequency of urinary incontinence and urination decreased significantly with two different doses of mirabegron.

This improvement in symptoms was correlated with improvement in patient-reported outcomes, including treatment satisfaction, symptoms, and quality of life.

According to presentations at the American Urological Association meeting adverse events occurred at similar rates in the placebo-controlled and mirabegron-treated patients.

Mirabegron is a first-in-class agent developed specifically for the treatment of OAB that has not been approved by the FDA.  It selectively binds and activates beta-3 adrenoreceptors on bladder detrusor muscle to facilitate filling and storage.

Favorable results from phase II studies of mirabegron led to this phase III, randomized and placebo-controlled study involving more than 1,300 patients with OAB.  Investigators at 132 sites throughout the United States and Canada randomized the patients to receive either the placebo or 50-mg or 100-mg of mirabegron.  Researchers examined patient diaries recording changes in the number of daily episodes of urinary incontinence and urination from baseline to 12 weeks.

About three-fourths of study participants were women with a mean age of 60.  About four in ten patients had mixed stress/urgency incontinence with urgency predominance, a third had no incontinence, and the remainder had urgency incontinence.

The number of incontinence episodes per 24 hours had declined in all three treatment groups after 12 weeks, but there were more significant reduction in the 50-mg and 100-mg mirabegron treatment groups.  The incidence and severity of adverse events including hypertension, urinary tract infection, headache and nasopharyngitis were similar across the three groups.  Patient-reported outcomes were all significantly better in the mirabegron treatment groups compared with the placebo-controlled group.

In contrast to these mirabegron results, findings from a randomized trial of ONO-8359, a prostaglandin EP1 receptor antagonist, showed no significant improvement in any of its treatment groups.   The study involved 435 patients randomized to a placebo, tolterodine, or one of three doses of ONO-8539.  In this study, patients were randomized on the basis of findings from a three-day placebo run-in that showed at least eight micturitions per 24-hour period, at least one urgency episode per 24 hours, and at least six urgency episodes during the three-day run-in.  Researcher compared the number of urinations per 24 hours at baseline to 12 weeks.    They found no significant differences between any dose of ONO-8358 and placebo for any of the outcomes.

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Research Study for Treatment of Lower Urinary Tract Symptoms (LUTS) Due To Benign Prostatic Hyperplasia (BPH)

Are you a man age 50 or older?

Do you have to urinate frequently during the day and at night?

Do you have trouble urinating?

Are these and other urinary problems interfering with your life and your relationships?

If you answered “yes” to the above questions, you may be a candidate for the L.I.F.T. Study.

The L.I.F.T. Study is an FDA approved research study to evaluate the UroLift system to support a premarketing application to FDA.  Its purpose is to determine the safety and effectiveness of the UroLift system for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).  The study is being conducted at urology practices throughout the U.S., in Canada and in Australia.

BPH is a non cancerous condition that causes the prostate to enlarge as men age.  When the enlarged prostate presses on the urethra, it can cause bothersome urinary symptoms. The UroLift System is a minimally invasive approach to treating BPH that lifts/holds the enlarged prostate tissue out of the way so it no longer blocks the urethra.  There is no cutting, heating or removal of prostate tissue. The goal of UroLift system treatment is to relieve symptoms so you can get back to your life and resume your daily activities.

The UroLift system is an investigational device as such is limited by Federal Law to investigational use only.

To find out more about L.I.F.T. Study and UroLift system treatment and study locations, go to www.neotract.com.

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Antibiotic May Slow Bladder and Breast Cancer Cell Growth

Researchers have recently found that a common antibiotic prescribed for urinary tract infections may additionally slow and even stop the growth of breast and bladder cancer cells.  The study was performed by researchers at John Hopkins University School of Medicine.

Nitroxoline is the antibiotic of interest.  Traditionally, nitroxoline is used as a urinary antibacterial agent to combat the organisms commonly found in urinary tract infections.  However, the John Hopkins’ findings show that the antibiotic also blocks the formation of new blood vessels that fuel tumors.  With these results, nitroxoline may become a potential therapeutic agent for cancer.

“Angiogenesis, the growth of new blood vessels, plays an important role in tumor growth and metastasis, so inhibiting angiogenesis is a promising strategy for developing new anticancer drugs,” Dr. Jun O. Liu, a professor of pharmacology and molecular sciences at John Hopkins, said in regards to the findings.

More than 177,000 chemical compounds and drugs were tested.  The researchers were studying each drug’s ability to block the activity of a protein in order to inhibit the formation of new blood vessels.  The results were astonishing:  nitroxoline blocked more than 99 percent of the blood vessels at a low and safe concentration.

Even more promising is the fact that when the antibiotic was tested in mice, the treatment reduced breast cancer cell tumor volume by 60 percent and bladder cancer cell tumor by more than 50 percent.

Although the usage of nitroxoline to prevent the growth of bladder and breast cancer cells is promising, more clinical trials need to be conducted before a serious recommendation for treatment of bladder and breast cancer may be made.

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