Mac Overmyer

Gynecologists derive higher complication rates than urologists during the first 30 days following sling procedures for urinary incontinence, according to a multicenter study presented at the European Association of Urology annual congress in Munich, Germany.

Urologists, GYNs demonstrate slings' safety

	However, the difference was small and most complications were slight-primarily post-procedure urinary tract infections.

	The authors arrived at these findings by delving into data amassed by the American College of Surgeons National Surgical Quality Improvement Program (NSQIP). They reviewed 10,508 sling procedures for stress urinary incontinence conducted between 2006 and 2013.

	Procedures performed by gynecologists (5,970) were associated with a higher rate of UTIs (3.6%) compared to the 2.3% rate seen in 4,538 procedures conducted by urologists (OR: 1.55, 95% CI: 1.23-1.97, 

<.0001). Gynecologists also had a higher rate of overall complications than urologists: 4.1% vs. 2.9% (OR: 1.42, 95% CI: 1.15-1.76, 

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	“Large sample sizes can make small differences statistically significant. The question is whether they are clinically meaningful,” first author Björn Löppenberg, MD, a research fellow at Brigham and Women’s Hospital, Boston, told 

	The overall complication rate was 3.5%, with the majority (84.3%) of complications being UTIs. Thirty-day postoperative outcomes, including cardiovascular, pulmonary, thrombotic, septic, renal, wound, and bleeding complications, did not differ between the two specialties. Reoperation and readmission rates were also similar.

Brain activity in OAB patients characterized in study

	The above rates were similar despite differing patient characteristics. Patients treated by urologists tended to be older with a greater incidence of comorbidity and higher American Society of Anesthesiologist scores (ASA ≥3, 

Dr. LoppenbergIt is possible the complication rates are under-reported, noted Dr. Löppenberg, who worked on the study with Quoc-Dien Trinh, MD, and co-authors.

	“The NSQIP database codes only for complications that occur within 30 days of the procedure. We cannot account for long-term adverse events such as chronic pain and erosion, among others,” said Dr. Löppenberg, who explained that these complications would not be registered in the NSQIP database.

	Some 17.1% of the patients in the dataset underwent an additional procedure. Gynecologists performed twice as many additional procedures as urologists, 22.2% versus 10.5% 

<.0001), despite the higher comorbidity rates seen among patients being treated by urologists.

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	“We are not able to identify the underlying reason for this finding. The majority of these additional procedures were cystoscopies, and the majority were performed by gynecologists. It is possible that these findings simply reflect differences in surgical technique and approach,” Dr. Löppenberg said.

Next: Independent predictors of reoperation, readmission

	Independent predictors of reoperation and readmission rates were ASA scores ≥3 (OR: 1.6%, 95% CI: 1.2-2.0; 

=.001), prolonged operative time in the 75th percentile or higher (OR: 1.9, 95% CI: 1.5-2.3), and a gynecologist-conducted procedure (OR: 1.5, 95% CI: 1.2-1.9; 

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	Dr. Löppenberg said the study was prompted when Dr. Trinh and co-author Christian Meyer, MD, were asked to comment on a December 2015 

 article that examined factors associated with synthetic mesh removal following surgical interventions for stress urinary incontinence 

 That study found that over a 10-year span, complications were not significantly influenced by the specialty of the surgeon conducting the procedure.

	Specialists at the Henry Ford Hospital Health System, Vattikuti Institute of Urology, Center for Outcomes Research, Analytics and Evaluation, Detroit, participated in the study. It will be presented again in a poster session at the AUA annual meeting in San Diego.

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Articles

Does specialty affect  sling complication rate?

Managing stones in pregnant women can be challenging because many of the imaging technologies used to localize the stones, and the primary therapies to remove them or ease symptoms, may carry risks and/or side effects that might be amplified by the pregnancy. 

	A retrospective study of 28 patients conducted by Mayo Clinic researchers suggests that medical expulsive therapy employing tamsulosin (Flomax), an alpha-1-adrenergic receptor antagonist, can benefit pregnant women with minimal risk to either mother or child, as reported at the AUA annual meeting in New Orleans. 

	"Our study suggests that tamsulosin as medical expulsive therapy for symptomatic stones in pregnant patients is safe and may increase stone passage rates," George Bailey, MD, a urology resident at Mayo Clinic, Rochester, MN, told 

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	"Larger cohorts will be helpful in further defining the role of tamsulosin for pregnant stone formers, but our initial experience indicates that the option of tamsulosin medical expulsive therapy should be part of the discussion when physicians counsel symptomatic pregnant stone formers, especially when symptoms are severe enough that they are considering things like stent placement, ureteroscopy, or percutaneous nephrostomy tube," said Dr. Bailey, who worked on the study with Amy Krambeck, MD, and colleagues.

	To arrive at these conclusions, the Mayo team retrospectively identified 28 pregnant women with documented tamsulosin therapy for symptomatic urolithiasis. Of these women, 20 (71%) had urolithiasis documented by imaging and 23 (82%) had documented hydronephrosis. The median treatment period tamsulosin was 3 days (range, 1 to 110). Three patients (11%) were treated in their first trimester, 10 (36%) in their second, and 18 (67%) in their third trimester. Several patients had more than one course of therapy.

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	Dr. Bailey observed that the pattern of symptomatic stone formation in pregnant women seen in the study was somewhat typical.

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	"Pregnant women have the same risk of stone formation as their non-pregnant peers. Most pregnant women who present with symptomatic nephrolithiasis will do so in the second or third trimester. That trend was seen in our patient population," he said.

	He said that one of the challenges in treating stones in pregnant women is that the gold standard for imaging and localizing stones is computed tomography.

	"Obviously, radiation exposure is something we try to avoid in pregnant women. Often pregnant women with flank pain will undergo ultrasound imaging, which, unfortunately, has low sensitivity and specificity for stones. Women in our series were treated with tamsulosin, 0.4 mg/d, until the stone passed or their pain resolved," said Dr. Bailey. The study reported that the median duration of in-utero exposure to the agent was 3 days.

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	Refractory renal colic requiring surgical intervention presented in eight patients (29%). This included one who required ureteral stent placement, one who required ureteroscopy without stent placement, five who required ureteroscopy with stent placement, and one who required a nephrostomy tube.

NEXT: No significant differences seen compared to matched cohort without tamsulosin

	The study matched the treatment cohort 2:1 with a group of pregnant women with symptomatic urolithiasis who did not get tamsulosin and found no significant differences between the two groups. The mean maternal age of the study group was 28.4 (SD, 4.15) years with the mean gestational age of the child being 38.1 weeks. Six infants (22%) were born preterm. All infants were considered appropriate for gestational age, and there were no cases of spontaneous abortion, intrauterine demise, or congenital anomalies.

	Dr. Bailey responded to a question about the size of the study, saying that it was not unusual.

	"Practitioners are understandably hesitant to give medications without a proven safety record to pregnant women, which makes even retrospective studies difficult to conduct,” he said. “Many investigations of medication exposure in pregnant women start with small, retrospective studies. The sample size of this study reflects those challenges and is on par with other initial single institution investigations into medication exposure risk during pregnancy.”

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New study data suggest an answer to the problem of managing stones in pregnant women.

MET found safe, efficacious in pregnant stone patients

The first clinical trial of a novel ultrasound technology shows that it can safely reposition stones in situ to make them more amenable to natural passage and treatment.

Dr. HarperThe approach can also provide useful diagnostic information in distinguishing a larger stone that would not pass from a cluster of much smaller, passable stones, according to the study's authors.  

	"We have completed the first clinical trial of this technology in 15 patients and have met the goals of the study. The primary goal was to demonstrate that we could move stones within the kidney in humans. We did that in 14 of 15 patients. Secondary goals were also achieved in that it was tolerated in the clinic setting without pain, and there were no adverse events related to the procedure," first author Jonathan Harper, MD, associate professor of urology at the University of Washington, Seattle, told 

	"By repositioning stones, we were able to facilitate stone passage in four of the six post-lithotripsy patients," he said.

NEXT: Acoustic radiation force of ultrasound waves transcutaneously moves stones within the kidney

	Dr. Harper described the technology developed by the Washington team as a new application of ultrasound that uses the acoustic radiation force of ultrasound waves to transcutaneously move stones within the kidney. The trial, which was presented at the AUA annual meeting in New Orleans, initially involved 13 awake, non-anesthetized patients selected without restriction of body habitus, stone size, or stone location. An additional two patients were incorporated in the study to gain more knowledge of stone repositioning by direct visualization of stone movement during ureteroscopy. This has led the group toward more optimized treatment parameters.

	The majority (11) of the 15 patients were men, average age 56 (+/–11) years, and average body mass index was 29.3 kg/m

 (+/–3.1). Stone sizes ranged from 1 mm to 14 mm and were located in the lower pole (24), interpolar (10), upper pole (four), and renal pelvis/ureteropelvic junction (four).

Alpha-blocker found safe in pregnant stone formers

	Stones were successfully relocated in all six post-lithotripsy patients, four of whom passed more than 30 fragments in the days following the procedure. One subject passed two 2-mm fragments before leaving the clinic.

	One finding that was unanticipated was that in four patients, a stone that appeared to be greater than 5 mm on imaging was visually confirmed to be a composite of smaller, passable stones with repositioning.

	The technology described by Dr. Harper is innovative.

	"The probe we used in the trial is a standard, off-the-shelf ultrasound transducer in terms of imaging capabilities, but the ultrasonic propulsion technology is completely new and innovative. There is no published data outside our work describing this technology or its application,” said Dr. Harper, who noted that it was developed in conjunction with the University of Washington's Applied Physics Laboratory.

	"The imaging and ultrasonic propulsion are incorporated into the device for real-time feedback. The probe is used for imaging at one setting, and a different setting allows for propulsion or repositioning. The way the ultrasound is delivered is completely different than standard imaging. We have a clinical prototype, and we have had success with our first 15 patients.

	“Given the results of the clinical trial, there is a role for this technology in its current state, but we think we can make it better. Some of the new (probe) designs that have been developed over the past few weeks suggest it may have broader applications, whether these are moving a clump of fragments, detaching a small stone, or repositioning a larger obstructing stone," he said.

	Moving stones using the technology is not as simple as shooting pool.

	"There is a learning curve to this technology. You have to be able to use renal ultrasound and visualize the path you want to move the stone. If you are aiming into a wall, the stone is not going to go anywhere. It can take some trial and error to move the stones," Dr. Harper said.

	The finding that a larger stone was actually a collection of smaller stones or fragments turned out to be a diagnostic advantage that was unanticipated. Such findings can lead to revisions of clinical management, Dr. Harper said.

	The study was funded by the National Space Biomedical Research Institute, a division of NASA, and the National Institutes of Health.

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Advances in the diagnosis and treatment of 

 are among the great medical accomplishments of the latter part of the 20th century and beginning of the 21st. Five-year survival rates for newly diagnosed loco-regional cancer advanced from 68% in 1975-’77 to 83% in 1987-’89 to nearly 100% in 2003-’09, according to the American Cancer Society. This victory, however impressive, is incomplete.

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	In recent years, a number of leaders in the field of 

 have identified a significant cohort of men who would likely benefit from aggressive treatment of their disease but are not getting it for a variety of reasons. Peter Carroll, MD, MPH, co-director of urologic cancer at the Helen Diller Comprehensive Cancer Center and chair of the department of urology at the University of California, San Francisco, is one of these specialists.

	“There are two issues. There are patients who are being over-treated. That issue is being recognized and addressed. And then there are those who are undertreated. Few seem cognizant that there is under-treatment of high-risk disease,” Dr. Carroll told 

	“There is indeed under-treatment of high-risk disease,” said Laurence Klotz, MD, chief of the division of urology at Sunnybrook Health Sciences Center in Toronto, another specialist who is addressing this issue.

 readers tend to agree with Dr. Carroll and Dr. Klotz. A December 2014 reader poll on the 

 website asked, “Are men with higher risk prostate cancer being treated aggressively enough?” More than half (57%) said no, while 43% said yes.

	Epidemiologists are beginning to get a handle on the problem. Despite being able to diagnose and definitively treat prostate cancer in its early stages, the disease remains a leading killer, second only to skin cancer in American men. The American Cancer Society estimates that there are perhaps 3 million men living with the disease in the United States. The ACS further estimates that prostate cancer will have claimed 29,480 lives last year. Of the 233,000 men estimated to have presented with the disease in 2014, approximately 15% (or 34,950) will likely have high-risk disease, according to the ACS and findings published in 

	“If you look at the numbers, you will see that the majority of cancers are localized cancers. These constitute about 81% of the diagnoses. Regional disease constitutes about 11% and distant disease, about 4%,” Ahmedin Jemal, DVM, PhD, vice president of surveillance research at the American Cancer Society, told 

	One of the key findings of the 2014 ACS 

“Cancer Treatment & Survivorship” report

 is that a majority of men aged 75 years or older receive neither prostatectomy nor radiation for their disease.

	“Older patients are more likely to be undertreated than younger patients,” said Dr. Carroll. “They are more likely to receive palliative rather than definitive treatment. We have found that older patients receiving palliative treatment such as hormonal therapy have twice the risk of dying of the disease as younger men treated with radiation or ­surgery.”

Dr. Klotz“I think radiation may be both under- and overused,” Dr. Klotz said. “My view, which is not universally accepted, is that the really high-risk young patient should be treated with surgery followed by radiation and hormones. It may be a form of under-treatment to treat a high-risk patient with radiation alone and deny him the benefit of surgical resection.

	“It breaks down along specialty lines,” Dr. Klotz added. “The radiation oncologists think that these patients should get radiation and the urologists think they should get surgery. For most of my career, I viewed radiation and surgery as more or less equivalent, but I don’t hold that view anymore. There are now nine propensity studies that have been published. All show that mortality in patients treated with radiation alone is higher than in patients treated with surgery as the first modality. These findings are particularly applicable to high-risk patients.”

Next: Multi-modality therapies beneficial

	There is a growing body of evidence that multi-modality therapies benefit high-risk patients.

	“We found that patients who receive radiation therapy with androgen deprivation therapy have a better overall 5-year survival than those who received only ADT,” said Chun Chieh Anna Lin, PhD, MBA, senior epidemiologist, surveillance and health services research at the American Cancer Society.

	Dr. Lin cited a study that she and colleagues presented at the American Society for Radiation Oncology’s 2014 annual meeting in San Francisco. The authors looked at 3,682 patients with lymph node-positive disease but no distant disease. One-third (1,204) received androgen deprivation therapy alone, while half (1,852) received combined ADT and radiation. Patients receiving combined therapy evidenced a 58% decreased risk of 5-year mortality compared to those who received hormonal therapy alone.

	The study authors made another observation that has troubled prostate cancer experts for many years without resolution. Non-clinical factors can have significant impact on therapy selection and outcomes.

	Dr. Lin, Dr. Jemal, and collaborators at Massachusetts General Hospital in Boston reported that, “Prior to propensity score matching, patients who were aged 65 or younger, those with private insurance, lower comorbidity scores, higher Gleason scores, lower PSA values, and higher clinical T-stage were significantly more likely to receive combined therapy” 

	“Treatment varies a lot. I would say that variations in approach, particularly among radiation oncologists, is greater for high-risk patients than for any other aspect of this field,” Dr. Klotz said.

	“We have also shown that there is a great deal of variability in the treatment of prostate cancer, variability that is not related to patient demographics such as age, comorbidity, or disease characteristics such as PSA, tumor stage, or grade,” said Dr. Carroll. “About a third of variance in treatment appears to be related to practice site. That is a higher degree of variability than you would see with hip fracture treatment or coronary bypass procedures. And I see no reason not to think there isn’t variability among academic medical centers.”

	Dr. Carroll co-authored a 2010 paper with colleagues Matthew Cooperberg, MD, MPH, and Jeanette M. Broering, PhD, that looked at factors influencing clinical decisions 

 Although the study was not powered to identify these factors definitively, the authors stated that, “Explanations for the observed variations are speculative, but presumably reflect variable physician training, experience, and personal outcomes; payor mix, reimbursement patterns, and other financial incentives; the local medicolegal environment; uneven penetrance of novel technologies; impact of local culture on patient beliefs and preferences; and many other factors.”

	Comorbidities appear as one of the primary factors weighed in treatment decisions. Timothy Daskivich, MD, and colleagues at the David Geffen School of Medicine at UCLA looked at treatments in men with multiple comorbidities and early-stage prostate cancer in a study recently published in 

 In comparing 516 men with low-risk disease, 475 men with intermediate-risk, and 432 men with high-risk disease, they found that men with high-risk disease had a lower probability of aggressive treatment regardless of comorbidity.

	The researchers also found that aggressive treatment was not associated with a survival benefit in men with low- and intermediate-risk disease, but a trend toward benefit was seen in men with high-risk disease. They concluded that in men with significant comorbidities, aggressive treatment was poorly matched with tumor risk, and that while conservative management may be applicable in men with low- and intermediate-risk disease, aggressive treatment may benefit men with high-risk disease.

Dr. CarrollDr. Carroll said that identifying risk accurately is one path toward effective treatment of men with high-risk prostate cancer.

	“Those who assess risk most accurately have a better understanding of the disease and treat more appropriately. In other words, those who evaluate a patient more precisely and in greater detail get it right more often than not,” he said.

	One of the aspects of the issue seldom mentioned is the range of definitions used to identify high-risk patients. There are at least five, including those from the AUA, European Association of Urology, Radiation Therapy Oncology Group, National Comprehensive Cancer Network, and the University of California, San Francisco, which developed the Cancer of the Prostate Risk Assessment. While the differences are subtle, they can influence studies of outcomes, handicap comparisons of treatments, and have profound influence on decisions being made with individual patients.

	Questions surrounding the diagnosis and treatment of high-risk disease are likely to persist, at least into the near future.

	“There are no randomized trials comparing surgery to radiation, and that is the problem. It then becomes a question of which data you choose to believe. To my mind, it is a little bit like the Middle East where Israelis and Palestinians both have their own narratives. It sounds as if they are talking about two different situations, but in fact it is the same situation,” said Dr. Klotz.

	Dr. Carroll finds parallels between the evolution of active surveillance, which is reducing overtreatment of low-risk disease, and the current status of under-treatment of high-risk disease.

	“There has probably been a tripling of the utilization of surveillance in the last few years,” Dr. Carroll said. “It was put front and center before urologists and they responded by changing practice patterns. We are not where we need to be, but there has been a remarkable uptake. That is what happens when you call attention to an issue. Things fall into place.

	“What we are seeing now is a migration toward the more appropriate treatment of low-risk disease and a more aggressive approach to high-risk disease.”

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Advances in the diagnosis and treatment of prostate cancer are among the great medical accomplishments of the latter part of the 20th century and beginning of the 21st. Five-year survival rates for newly diagnosed loco-regional cancer advanced from 68% in 1975-’77 to 83% in 1987-’89 to nearly 100% in 2003-’09, according to the American Cancer Society. This victory, however impressive, is incomplete.

Author | Mac Overmyer

Articles

Does specialty affect sling complication rate?

MET found safe, efficacious in pregnant stone patients

Ultrasound stone repositioning facilitates passage

High-risk prostate cancer brings new challenge