Archive | Bladder Treatment

Solifenacen May Improve Sleep-Related Quality of Life for Overactive Bladder and Nocturia Patients

Adults who have an overactive bladder and nocturia might benefit from solifenacin, which may improve quality of sleep and sleep-related quality of life by decreasing the number of overnight trips to the bathroom and increasing the amount of urination per trip.  Solifenacin is a urinary antispasmodic approved by the US Food and Drug Administration (FDA) for use in adults in 2005.  It works by relaxing bladder muscles to prevent urgent, frequent, or uncontrolled urination.

These new findings come from a subgroup exploratory analysis of 962 Japanese men and women, 20 years or older with overactive bladder and nocturia, who participated in a randomized, controlled 12-week trial study evaluating solifenacen (5 and 10 milligrams) against a placebo.  Only participants who urinated at least once overnight were included in the analysis.  The participants recorded their results in a bladder diary.  While the decrease in nocturia was statistically significant for those given 10 milligrams of solifenacen, the results were not statistically significant for those given 5 milligrams.

Both the 5mg and 10mg dose significantly increased the amount of urination per trip to the bathroom by 30 and 41 milliliters, respectively.  With both doses, the amount of undisturbed sleep time increased by an average of 59 and 60 minutes, respectively, compared to 33 minutes with the placebo.  The study showed most significant improvements in sleep-related quality of life.  Because of the exploratory nature of this study, the authors of the Journal of Urology report caution that the results need to be interpreted with caution.  The analysis was supported by Astellas Pharma Inc.

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Increase of laparascopic radical nephrectomies for small renal tumors is alarming

Kidney cancer specialists reported that the use of radical nephrectomy for small renal masses remains “alarmingly high,” particularly among older patients.  Between 1995 and 2005, the use of radical nephrectomy decreased by 50 percent, but most of the decline was offset by a dramatic increase in the rate of laparascopic radical nephrectomies.

Use of laparascopic techniques to remove small renal masses increased by 35 percent overall.  Nephron-sparing surgery, on the other hand, increased by 15.5 percent.  These findings were presented at the American Urological Association meeting.

Marc Smaldone, MD, of Fox Chase Cancer Center in Philadelphia reported that in 2005, 77 percent of patients were treated with radical nephrectormy, either open or laparoscopic.

Investigators reported in another study that older patients were significantly more likely to have radical nephrectomy for small renal tumors compared with their younger counterparts.

James McKiernan, MD, of Columbia University in New York, said that this disparity is most common in patients with the smallest masses.  Over a third of small renal masses are less than 4cm, and incidental discovery of small masses has increased 244% since 1982.  The dramatic rise in the detection has coincided with the aging of the American population.

The AUA clinical guidelines for management of small renal masses emphasize disease control, nephron preservation, and use of minimally invasive techniques whenever appropriate.  Noting a potential to reduce the risks of chronic kidney disease, cardiovascular disease, and mortality, the guidelines cite nephron-sparing surgery as the reference standard.

Investigators reviewed the NCI Surveillance, Epidemiology, and End Results (SEER) Medicare-linked database from 1995 to 2005.  The team identified all patients treated for small renal masses and grouped the patients by type of surgical procedure: open radical nephrectomy, open partial nephrectomoy, laparoscopic radical nephrectommy, and laparascopic partial nephrectomy.  In 1995, radical nephrectomy accounted for 93% of all the procedures, 87% of which involved open surgery. In 2005, radical nephrectomy’s total share of procedures had declined to 73%, more than half (40.8%) performed laparoscopically.  During this time, the rate of open partial nephrectomy increased from 6.7% to 13.5%, and use of laparoscopic partial nephrectomy increased from 0.6% to 9.3%.

Mckiernan reported from a review of SEER data that identified 18,000 patients who had small (4 cm or less) localized tumors between 1998 and 2007 that the preference for radical versus nephron-sparing surgery has become even more pronounced among older patients.  The study analyzed trends in the use of radical nephrectomy by age and tumor size.  Two thousand seven hundred and thirty three patients were 27 or older, and 15,312 were younger than 75.

Overall, radical nephrectomy was the treatment of choice for both age groups, but was significantly greater among older patients: 66% of all surgical procedures compared with 59% among younger patients.  Stratification by tumor size showed that the age-related difference in use of radical nephrectomy increased as tumor size decreased. Although use of radical nephrectomy decreased with tumor size in both age groups, the magnitude of the difference between the groups increased.

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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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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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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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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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Post Prostate Surgery Pelvic Floor Exercises Ineffective in Improving Male Incontinence

According to a two randomized trials reported in The Lancet one-to-one pelvic floor exercise therapy for urinary incontinence after prostate surgery is no more effective than standard care.

Cathryn Glazener, PhD, from the University of Aberdeen, United Kingdom, and colleagues, reported that urinary incontinence is common immediately after prostate surgery.  As a result men are often advised to do pelvic floor exercises, but evidence to support this had been inconclusive.  The study sought to establish if formal one-to-one pelvic floor muscle training reduces incontinence.  It was supported by the National Institute of Health and Health Technology Assessment Programme.

The first trial enrolled men in the United Kingdom who had incontinence six weeks after radical prostatectomy, and the second trial enrolled men in the United Kingdom who had incontinence six weeks after transurethral resection of the prostate (TURP).  These trials compared the effect of four one-to-one therapy sessions during a three-month period to standard are and lifestyle advice only.

In trial 1, the rate of urinary incontinence at 12 months in the intervention group was not significantly different from that in the control group. Findings were similar in trial 2. These findings were unchanged by adjustment for minimization factors or by treatment-received analyses.  There were no adverse effects reported in either trial.

The authors conclude that one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be physically effective or cost effective.

Limitations of this study include incomplete blinding and lack of objective measures of incontinence.

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FDA Warns Against Procedure Used to Treat Pelvic Organ Prolapse

The US Food and Drug Administration (FDA) have announced that a mesh device used to support the pelvic organs and help ease incontinence in women seems to be riskier than previously thought.  The surgical placement of this device through the vagina to fix a condition known as pelvic organ prolapse might have increased risks as compared to other surgical methods.  The FDA has asked surgeons to consider other treatment options and to fully inform their patients of the potential complications of the surgical mesh, which is a permanent implant that may not be possible to remove.  Between 2008 and 2010, the FDA received over 1500 “adverse event” reports relating to patients who had undergone the mesh procedure.  This figure was five times as many as was reported between 2005 and 2007.  Common problems cited include pain, infection, bleeding, pain during sexual intercourse, and urinary problems.  Other problems include the protrusion or exposure of the mesh from the vaginal tissue or organ perforation during the surgical implantation of the mesh.

Pelvic organ prolapse is characterized by a weakening or stretching of internal structures that support the bladder, bowel, and uterus, causing these organs to drop below their normal position and bulge (prolapse) into the vagina.  According to the FDA, this can then lead to pelvic pain and disruption of sexual, urinary or defecatory function.

In 2010, over 100,000 mesh procedures were used for the treatment of pelvic organ prolapse, out of which 75,000 were transvaginal, in the United States.

In examining data from 1996 to 2010 comparing mesh surgeries to non-mesh surgeries, the FDA found that mesh surgeries seemed to be riskier but had no greater clinical benefit.  The FDA thus urges health care providers to remember that pelvic organ prolapse can be treated with other methods that result in fewer complications and adverse events and urges patients who have undergone the procedure to check in regularly with their doctors, especially if complications arise.  The American College of Obstetricians & Gynecologists (ACOG), who had discussed concerns about the mesh with the FDA in October 2010, has supported the FDA’s decisions.  In early September, the FDA plans to convene an independent expert panel to meet and discuss this issue.

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Single-Incision Mini-Slings (SIMS) Don’t Perform Well in Stress Urinary Incontinence

Results from the review of Dr. Mohamed Abdel-Fattah of the University of Aberdeen and his colleagues on single-incision mini-slings (SIMS) compared to standard midurethral slings (SMUS) in their short and medium term efficacy shows SIMS don’t perform as well in women with stress urinary incontinence.

The researchers conducted a literature search and a meta-analysis of data from nine randomized trials involving 758 women followed for an average of 9.5 months.

Although SIMS were associated with significantly shorter operative time, lower day 1 pain scores and less postoperative groin pain, there was no significant difference in the quality of life scores between the groups.  But at 6 to 12 months, the patient reported cure rate (risk ratio, 0.83) was significantly lower with SIMS vs SMUS as was the objective cure rate (risk ratio, 0.85).

The SIMS group also had a significantly more repeat continence surgery (risk ratio, 6.72) and de novo urgency incontinence (risk ratio, 2.08).

Dr. Abdel-Fattah said “The results from this review will have a significant impact on surgical practice of urologists and urogynecologists.  We We have shown that the evidence from the current medical literature does not support the use of SIMS in surgical treatment of women with stress urinary incontinence especially that the standards have been set high with the standard mid-urethral slings,”

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