Chase Doyle

When it comes to urinary stone disease, it appears that prescribers know what they’re doing. According to a study presented at the World Congress of Endourology and SWL in London, non-adherence to kidney stone medications led to a significant increase in adverse health outcomes.  

	“Adherence to preventative pharmacologic therapy agents in urinary stone disease is associated with decreased rates of emergency department (ED) visits, hospitalizations, and stone-directed surgery,” reported co-author Yooni Yi, MD, urology resident at the University of Michigan, Ann Arbor, who worked on the study with first author Casey Dauw, MD, senior author John Hollingsworth, MD, and colleagues.

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	As Dr. Yi explained, urinary stone disease is best viewed as a chronic condition in which secondary prevention plays an important role. However, the effect of non-adherence to preventive pharmacologic therapy on adverse health outcomes is unknown. For this study, the goal of the authors was to evaluate the rates of stone-related ED visits, hospitalizations, and stone-directed surgery within 2 years of diagnosis between adherent and non-adherent patients with urinary stone disease.

	Using MarketScan data from 2002 to 2006, the authors identified 8,890 patients with a diagnosis of nephrolithiasis who were prescribed preventive pharmacologic therapy with a 2-year follow-up. Dr. Yi and colleagues measured adherence using the proportion of days covered (PDC) formula, with adherent defined as PDC >80%.

	According to Dr. Yi, only 51.1% of patients were found to be adherent to therapy.

	“Adherent patients tended to be older, less healthy, and from the Midwest,” said Dr. Yi. “They also were more likely to be salaried, work part-time, and have comprehensive health insurance.”

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	When compared to non-adherent patients, those who were adherent were also found to have lower odds of ED visits, stone-directed surgery, or hospital admission.

	“Patients adherent to preventative pharmacologic therapy had 27% lower ED visits, 41% lower odds of hospital readmission, and 23% lower odds of stone-directed surgery. This indicates a significant impact that adherence has on health outcomes,” said Dr. Yi.

	While the authors observed common factors among adherent patients, which may influence treatment duration, Dr. Yi acknowledged the difficulty of predicting adherence in advance.

	“It’s truly difficult to assess why or why not these patients were adherent,” she said, “so I think that might be the next thing that we look at. I’d like to determine whether or not patients are adherent because of the frequency of medications or side effects of medications or some other cause. In the meantime, these results at least provide a means of conversation between the physician and the patient that will hopefully incentivize them when it comes to their stone therapy in the future.”

Alpha-blocker may have benefit in larger stones

	Despite the obvious statistical improvement in outcomes related to adherence, one member of the audience expressed surprise that the gap between adherent and non-adherent patients was not more pronounced. When questioned about the relatively small difference in the need for surgery between adherent and non-adherent groups, Dr. Yi said the difference was not unexpected.

	“But one thing that you might consider is that this is only a 2-year follow-up,” she responded. “If you were to extend this study out to a 5-year follow-up, maybe there would be more of an impact.”

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When it comes to urinary stone disease, it appears that prescribers know what they’re doing. According to a study presented at the World Congress of Endourology and SWL in London, non-adherence to kidney stone medications led to a significant increase in adverse health outcomes.

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A novel treatment for the targeted removal of prostate tissue may soon be coming to a hospital near you. According to the results of a phase II study presented at the AUA annual meeting in New Orleans, Aquablation, a minimally invasive water ablation therapy, demonstrated efficient and precise resection of prostate tissue in patients with 

	“Based on what we have seen and experienced, Aquablation is promising, safe, and feasible. This combination of surgical mapping with the high-velocity saline and robotic guidance will considerably shorten ablation time in the operating room,” said lead author Peter Gilling, MD, associate professor of surgery at Grace Prostate Cancer Center, Tauranga, Bay of Plenty, New Zealand.

	According to Dr. Gilling, interventional therapy is an option to alleviate symptoms for men who fail medical management of BPH, but current treatments are a trade-off between improvement of patient symptoms and risk of complications.

	“Aquablation has the potential to standardize BPH surgery, reduce the level of complexity required to deliver safe and effective therapy, and ultimately improve the quality of life for men suffering from BPH,” he said.

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	The Aquablation system uses the still-investigational AquaBeam (PROCEPT BioRobotics Ltd.) to deliver a precise, high-velocity, saline jet at room temperature, allowing precise control, Dr. Gilling explained. The system has three components: a conformal planning station, which plans the depth and area of tissue to be removed; a transrectal ultrasound display; and a robot arm, which attaches to the endpiece.

	The study enrolled 21 patients at two sites in Australia and one site in New Zealand. The authors evaluated the pre-, intra-, and postoperative complication rate, quality of life symptoms, urinary flow rate, and urodynamic obstruction as confirmed by urodynamics. Although Dr. Gilling presented 6-month data, follow-up is planned through 3 years.

	“The procedure had a 100% technical success rate,” Dr. Gilling reported, “and reduced symptoms demonstrated by a 15.9-point decrease in the mean International Prostate Symptom Score (IPSS) at 6 months.”

	Improvement in urine flow was also observed, with a 10.1 mL/sec increase in the peak urinary flow rate (from 8.6 to 18.7 mL/sec).

	The mean procedure and resection times were 38 minutes and 5 minutes, respectively. Postoperative dysuria (painful urination) was minimal and adverse events were typically mild and transient. There was no occurrence of urinary incontinence or loss of ejaculatory or erectile function among study patients.

	“Most patients had their catheters removed the morning after surgery and were discharged,” Dr. Gilling noted.

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	Although the cost of the device has yet to be determined, Dr. Gilling suggested that Aquablation might one day be a preferred option of treatment if the price remains low.

	“Economics will come into the equation,” he said, “and will depend on the actual cost of the device and how much the disposable handpieces cost. This should be weighed against the considerably shortened operating room time that is expected and also the quantifiable and precise nature of planning. I think the administrators do like this element.”

	The next step for the technology will be the W.A.T.E.R study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue), a prospective, randomized, blinded controlled clinical trial that will begin later this year and, according to Dr. Gilling, will “provide definitive clinical data to evaluate the efficacy of the procedure.”

	PROCEPT BioRobotics provided funding for the study. Dr. Gilling is a consultant/adviser and investigator for PROCEPT BioRobotics, and his co-authors are investigators for the company.

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A novel treatment for the targeted removal of prostate tissue may soon be coming to a hospital near you. According to the results of a phase II study presented at the AUA annual meeting in New Orleans, Aquablation, a minimally invasive water ablation therapy, demonstrated efficient and precise resection of prostate tissue in patients with BPH.

BPH modality may offer efficient option

The prostatic urethral lift (PUL [UroLift, NeoTract, Inc.]) yields successful 3-year durability and also has a superior rate of improvement of 

 symptoms compared to transurethral resection of the prostate (TURP), according to separate studies presented at the AUA annual meeting in New Orleans.

Dr. Roehrborn“PUL offers a clinically meaningful improvement in lower urinary tract symptoms (LUTS) and urinary flow that can be sustained for 3 years. The procedure is associated with low morbidity and preservation of sexual function,” said Claus G. Roehrborn, MD, professor and chairman of urology at the University of Texas Southwestern Medical Center in Dallas. 

	The UroLift is a permanent implant sized (in situ) to accommodate the prostate. The goal is to widen the urethral channel by lifting or holding enlarged prostate tissue out of the way.

BPH technique efficacious even in severe obstruction 

	One international study, known as the L.I.F.T. study, was conducted in 19 centers (14 U.S., three Australian, two Canadian). The authors randomized 206 subjects 2:1 for PUL versus sham. The sham was single-blinded, and the assessor at each investigator site was also blinded to the actual treatment.

	Patients were over the age of 50 years with an AUA Symptom Index (AUASI) over 13 and maximum urinary flow rate (Qmax) under 12 mL/s. Patients underwent washout of alpha-blockers, 5-alpha-reductase inhibitors, and anticoagulants.

NEXT: AUASI reduction sustained through 3 years

	AUASI reduction sustained through 3 years

	For the 140 patients treated with PUL, AUASI reduction was 44% after 1 month and sustained at 43% through 3 years 

<.0001). Adverse events were typically mild and transient, with the most frequent being hematuria, dysuria, pelvic pain, urgency, and urge incontinence. Sexual function, however, was preserved with no incidence of de novo or sustained erectile or ejaculatory adverse events.

	“At 3 months, the patients had a significant improvement in their symptom score, urinary flow rate, quality of life, and BPH index, compared to the sham group. All sexual questionnaires showed no changes between the active and the sham group,” said Dr. Roehrborn, lead author of the L.I.F.T. study.

	After 3 years, change in symptom score was maintained at 8.9, which represents a 41% improvement and is significant against baseline, he reported. Flow rate also maintained a 53% improvement from baseline over the course of 3 years.

	Dr. Roehrborn noted that 2.1% of the implants had to be removed because they were exposed.

	“This is clearly an issue of experience and teaching the procedure,” he said. “The technique must be properly learned.”

	This study will continue to assess durability out to 5 years.

	“The procedure is well tolerated under local anesthesia, provides rapid and significant symptom relief, improves urinary flow rate, and preserves sexual and ejaculatory function in all patients,” Dr. Roehrborn concluded.

	Results of the L.I.F.T. study were also published in the 

	A separate, randomized controlled study compared the PUL procedure to the current standard of care, TURP.

	“TURP is the gold-standard surgery with regard to effectiveness in treating BPH but is associated with significant morbidity,” said lead author Neil Barber, MD, of Frimley Park Hospital NHS Foundation Trust, Surrey, United Kingdom. “When assessed for overall improvement, including LUTS, sexual function, continence, and safety, PUL subjects responded more consistently than TURP. Patient satisfaction rose more quickly for PUL and was sustained to 1 year.”

	The authors randomized 80 patients 1-to-1 across 10 centers in three countries in Europe. The primary endpoint of the study was to demonstrate non-inferiority of the PUL versus TURP using a composite endpoint that incorporates symptom relief, recovery experience, sexual health, continence preservation, and lack of high-grade adverse event.

	“The vast majority of patients, greater than 77%, returned to normal activity within a month,” said Dr. Barber. “They reported minimal impact upon erectile function, no impact upon ejaculatory function, no impact upon continence, and no levels of complications. It is interesting that the reoperation rate within this first year is higher in the TURP group as well.”

	According to Dr. Barber, patients treated with TURP had better outcomes in terms of International Prostate Symptom Score and maximum flow rate, but improvements in quality-of-life score were not statistically different within a year. However, when all of these endpoints are combined, a significantly better outcome is seen in the PUL group, with more than 50% of patients achieving overall improvement compared to 20% in the TURP group.

	“We see superior improvement in terms of rapid return to normal activity and rate of improvement in symptoms in the PUL group compared to TURP, as well as improvement in terms of preservation of sexual function,” Dr. Barber concluded. “But, clearly, longer term data will be required to understand that more fully.”

	NeoTract provided funding for both studies. Dr. Roehrborn is a consultant/adviser and investigator for NeoTract. Dr. Barber is an investigator for NeoTract. Several co-authors of both studies are consultants/advisers and/or investigators for NeoTract.

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The prostatic urethral lift (PUL [UroLift, NeoTract, Inc.]) yields successful 3-year durability and superior rate of improvement of BPH symptoms compared to transurethral resection of the prostate, according to separate studies presented at the AUA annual meeting in New Orleans.

The three most commonly performed sling procedures exhibit long-term success, according to a recent observational study presented at the AUA annual meeting in New Orleans. 

	In addition, patients treated with mid-urethral or pubovaginal slings for stress urinary incontinence maintained positive outcomes up to 10 years after surgery.

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	“In our complex heterogeneous population, we demonstrated results comparable to those previously reported in large randomized studies. Regardless of sling type, the majority of patients maintained subjective improvement up to 10 years after sling surgery,” said lead author Kevin Gioia, MD, a fellow in female pelvic medicine and reconstructive urologic surgery at Virginia Mason Medical Center in Seattle.

	Despite the importance of this information, according to Dr. Gioia, data on the durability of sling procedures longer than 5 years after surgery are limited.

	“This information is frequently requested by patients during preoperative counseling. We all know it can be very valuable when we’re counseling our patients,” said Dr. Gioia, who worked on the study with Kathleen Kobashi, MD, and colleagues.

Mid-urethral slings demonstrate efficacy, few adverse effects

	A retrospective review of the prospectively collected, longitudinal pelvic floor database identified 901 patients who underwent retropubic mid-urethral sling, transobturator mid-urethral sling, or autologous pubovaginal sling surgery. Patients were also required to have completed at least 1 post-op questionnaire within the 10-year follow-up period.

	“We defined success as either completely dry or our institution’s definition, the VM [Virginia Mason] success, which is the patient’s perception of being at least 70% improved or experiencing no more than one incontinent episode per week,” said Dr. Gioia.

	Satisfaction scores were also recorded on a scale of 0 to 10, with greater than 7 considered satisfied.

	Following retropubic procedures, VM success rates were 97%, 81%, and 70%, at 1, 5, and 9 years, respectively, and completely dry rates were 47%, 29%, and 31%.

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	“Completely dry rates are in the 30%-60% range, which is consistent with that previously reported in literature. VM success is higher as it is less stringent, albeit greater than 75% of patients were successful at 10 years plus. We were pleased to find that, although this is not longitudinal data, at any given time point the success rate and the completely dry rate remain respectable,” Dr. Gioia said.

	Although completely dry rates were lower for transobturator outcomes than retropubic, Dr. Gioia noted that a comparison cannot be made here as this was not a randomized trial.

	“These are two separate patient populations. Additionally, these numbers are similar to other known studies. VM success and satisfaction outcomes are still very robust across the board,” he said.

NEXT: Pubovaginal sling outcomes ‘respectable’

	Pubovaginal sling outcomes ‘respectable’

	Finally, outcomes for pubovaginal slings, despite lower initial leak-point pressures for patients and prior mesh erosions or complications with multiple, prior surgeries, were respectable, he said.

	“Completely dry rates were reasonable, ranging from 20% to 60%. VM success is high at every time point, and what’s most striking here is the very high patient satisfaction, particularly greater than 90% at greater than 10 years. This is a good reference point to keep in mind when counseling our patients because these tend to be our most complex patients.”

	According to Dr. Gioia, these results provide the surgeon with a tool for counseling patients preoperatively based on a target population representative of a high-volume referral center.

	“If patients are completely dry following mid-urethral sling surgery, our data indicate that they will be dry for greater than 5 years after transobturator and greater than 8 years following retropubic surgery,” he said.

	Further studies will allow for more accurate characterization of this population in order to better predict long-term outcomes, he concluded.

	Dr. Kobashi has worked on a scientific study/trial for Cook Myosite and has served as a consultant/adviser and meeting participant/lecturer for Allergan and Medtronic.

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