Samuel J. Peretsman, MD, explains how to get started with HIFU for prostate cancer.

Speaking of Urology Podcast

In this interview, Anne M. Suskind, MD, MS, discusses a recent Journal of Urology study in which she and her co-authors compared outcomes for pelvic organ prolapse surgery in nursing home residents and community-dwelling older adults. Suskind is associate professor of urology at the University of California San Francisco.

Effect of an online opioid training course on prescription patterns for urologic surgeries

Sperm parameters maintained in most men taking nasal testosterone gel

What quality registry data reveal about urethral stricture treatment

Videos

Anne M. Suskind, MD, MS, discusses the findings of the recent study, published in Urology.

Prolapse surgery outcomes compared in nursing home residents, community-dwelling adults

Cheryl Guttman Krader is a contributor to Dermatology Times, Ophthalmology Times, and Urology Times.

Findings from analyses of data collected in the multicenter prospective Canary Prostate Cancer Active Surveillance Study are adding to the body of literature regarding the utility and shortcomings of prostate magnetic resonance imaging (MRI) in active surveillance of men with low grade prostate cancer.

Describing their study as the largest cohort data on this topic, the researchers concluded its evidence suggests that a negative MRI in a patient on active surveillance does not ensure a lack of tumor upgrading. Furthermore, based on the findings, they recommended that systematic biopsy be performed in patients with negative MRI and in addition to targeted biopsies in men with a positive MRI.

The follow-up protocol for men enrolled in the Canary study included quarterly PSA testing, semiannual digital rectal examination, and surveillance prostate biopsies at 1 and 2 years after initial diagnosis and biennially thereafter. The performance of prostate MRI was left to the clinician’s discretion as was the technique used for prostate biopsy (cognitive or MRI/ultrasound fusion image guidance and amount of systematic sampling added to targeted biopsy cores). MRI images were graded based on PI-RADS.

To evaluate the diagnostic performance of MRI in active surveillance, the investigators identified men who had Gleason Grade Group less than 2 and a prostate biopsy within 12 months of multiparametric MRI. Their study included a total of 361 men who had 395 MRI studies and a median follow-up of 4.1 years. Of the 395 imaging studies, 284 were classified as positive based on the presence of a PI-RADS 3-5 lesion.

Biopsy reclassification to Gleason Grade Group 2 or greater on post-MRI biopsy was evaluated as the primary outcome, and 108 (27%) of the biopsies met the criterion for reclassification. The evaluation of MRI diagnostic performance showed that it had a positive predictive value of 31% and a negative predictive value of 83%, indicating that a negative MRI would miss a substantial proportion of patients with higher grade cancer. The negative predictive value of MRI was 82% if the definition of a positive MRI was changed to include only PI-RADS 4 or 5 lesions.

The researchers also created multivariable logistic regression models to assess the value of MRI for predicting biopsy reclassification. A base model incorporated only clinical factors (age, body mass index, number of negative biopsies after diagnosis, percent of total biopsy cores containing cancer from the previous biopsy, log-transformed prostate size, and log-transformed serum PSA), and a second model incorporated PI-RADS score.

Although presence of a PI-RADS 5 lesion versus a PI-RADS 1 or 2 lesion was found to be significantly associated with cancer reclassification to Gleason Grade Group 2 or greater, results of receiver operating curve analyses showed that discrimination between patients with and without biopsy reclassification improved only minimally by adding the PI-RADS score to the base model.

Another analysis evaluated the utility of MRI fusion biopsy by comparing the detection of high grade cancer in targeted versus systematic biopsies. It included data from 194 fusion biopsies and showed that the systematic biopsies detected a similar number of unique Gleason Grade Group 2 or higher cancers as the targeted biopsies (25 vs 21).

Commenting on these results, the investigators noted they are consistent with other research showing that targeted biopsies in men undergoing active surveillance may add little for predicting upgrading or reclassification. They stated, “if the goal of surveillance biopsy is to identify higher grade disease, systematic and targeted biopsies should be obtained for men with a region of interest identified on MRI.”

1. Liss MA, Newcomb LF, Zheng Y, et al.Magnetic resonance imaging for the detection of high grade cancer in the canary prostate active surveillance study. 

. 2020;204(4):701-706.doi: 10.1097/JU.0000000000001088

Articles

Based on the findings, investigators recommended that systematic biopsy be performed in patients with negative MRI and in addition to targeted biopsies in men with a positive MRI.

New report adds insight on prostate MRI for monitoring during active surveillance 

For this “Case of the Month” report, 

regarding the usage of renal mass biopsy (RMB) for small renal masses, touching on topics including how to determine the need for an RMB, contraindications to RMB, and how she performs the procedure. Concepcion is chief clinical urologist officer, Integra Connect, West Palm Beach, Florida, and clinical associate professor of urology, Vanderbilt University School of Medicine, Nashville, Tennessee. Scarpato is assistant professor of urology at Vanderbilt University Medical Center, Nashville, Tennessee.

66 y.o. African American male referred for an incidentally discovered solid right renal mass, 2.7 cm, in a work up for back pain. Pre/post contrast 15 HU—> 48 HU. No evidence of fatty attenuation.

PMH: (+) HTN, NIDDM, Atrial Fibrillation, Obesity

Dr Scarpato, this is a scenario we as urologists encounter quite frequently in our everyday practice, the incidentaloma small renal mass (SRM). Would you walk through with us please what is your working definition of a SRM, and what radiographic and clinical factors do you take into account as you are trying to determine the need for a renal mass biopsy (RMB)?

Yes, this is a common scenario in urology clinic, which has coincided with the rise in abdominal cross-sectional imaging. A small renal mass typically refers to growth on the kidney measuring less than 4 cm (T1a),

 and at many centers refers to incidentally detected masses less than 3 cm. The 3-cm cutoff originated in the VHL (von Hippel-Lindau syndrome) literature, which suggests that malignant tumors less than 3 cm have a very low likelihood of metastatic spread. Similarly, data indicate that patients with sporadic tumors less than 3 cm also have a low rate of progression and metastasis.

 When faced with this scenario, it is important to first consider the patient. What is his overall health, and does he have significant cardiac, pulmonary, renal, or other conditions? Does he have risk factors for RCC (renal cell carcinoma) or history of another primary malignancy that may have metastasized? In this patient, his diabetes and renal failure are important considerations when contemplating future renal mass intervention. When considering the mass, it is important to consider tumor location (central vs. peripheral, anterior vs. posterior, medial vs. lateral), endophytic vs. exophytic, size, solid versus cystic consistency, degree of enhancement and vascularity, as well as any significant necrosis. If prior imaging is available, it is helpful to assess growth kinetics over time.

In your opinion, are there any absolute or relative contraindications to RMB?

When counseling the patient, you need to consider the anatomic complexity of the lesion and the implications of the biopsy result on further management. In some patients, it may not be feasible to perform the biopsy due to truncal obesity and significant skin-to-tumor distance. Similarly, in the case of cystic lesions or solid masses in a challenging location, such as those that are medial and upper pole or perihilar, RMB may be relatively contraindicated.

Also, if results are unlikely to change your management plan, I would recommend against biopsy. Although not necessarily a contraindication, it is important to consider patients requiring anticoagulation for periprocedural management if biopsy is being pursued. And finally, historically, tumor seeding was felt to be a contraindication to the procedure. However, this is more of a theoretical risk as tumor seeding of the biopsy tract has not been significantly demonstrated in practice.

Do you differentiate between a solid SRM versus a Bosniak II, III, or IV in your recommendations for RMB?

Yes. This is important when considering RMB. Cystic masses are more challenging to biopsy. For cystic renal masses with higher malignant potential, those that are Bosniak (classification system) III or IV, biopsy is really only feasible if there is a solid component to target. Even then, there is a risk of a non-diagnostic biopsy result, sampling error, or tumor spillage. Generally, when cystic lesions are suspicious for malignancy, we proceed to surgery without attempted biopsy.

At your institution, when you feel a RMB is indicated, are you personally performing the procedure in an office setting or referring these patients to the interventional radiologist (IR) for percutaneous RMB?

At our institution, all RMB for SRMs concerning for cancer are referred to our interventional radiology colleagues. In the IR suite, the interventionalists provide sedation and local anesthesia unless there is a contraindication in which case an anesthesiologist would be involved.

That said, there are certainly urologists who routinely and successfully perform RMB in the office.

 As a specialty, we are facile with ultrasound and the evolution of ultrasound biopsy platforms makes RMB more accessible for us. It is reasonable for urologists who feel comfortable to offer RMB in the office to appropriately selected candidates, particularly those patients with posterior, subcostal lesions.

Obviously depending on site of service, are these best directed with ultrasound, CT, or MRI guidance?

As with most procedures, it comes down to the comfort and experience of the proceduralist and institution. He or she should perform the biopsy in the manner that is most appropriate for him or her. I don’t think one modality has been shown to be superior to the other. Most commonly RMB is performed with CT or ultrasound guidance. Ultrasound may be advantageous for characterization of some lesions, particularly endophytic renal masses, and it avoids contrast exposure, while perhaps being more convenient and cost-effective.

Would you please walk us through operationally the preferred technique you have adopted?

At our institution, patients are most often given sedation and local anesthesia. We are routinely taking core biopsies rather than FNAs (fine needle aspirations) because of the higher diagnostic yield. FNA is often inadequate unless biopsies are performed in conjunction with a cytopathologist on site who can assess the samples immediately. The number of cores taken depends on the quality of the cores, as assessed by the proceduralist. Often, we see 3 to 5 cores per sample. Following the procedure, patients are observed as an outpatient in the radiology suite with close attention to vital signs including pulse oximetry. Some centers may check urinalysis or renal ultrasound prior to discharge5. For complex patients, an overnight stay may be required for additional monitoring.

What are the major complications that have been reported with RMB?

Fortunately, major complications are rare. The literature indicates about a 2% risk of complication overall, with major complications occurring less than 1% of the time.

 Risks include hematoma, pain, infection, with more significant complications of pseudoaneurysm, pneumothorax, and the one we probably all think of first—bleeding. However, even in the face of anticoagulation or antiplatelet medications, the bleeding risk is still quite low. We can’t forget about the risk of nondiagnostic biopsy either, which can occur in up to 15% of RMBs.

Besides histopathology, do you typically send the tissue for any other type of biomarker/genomic testing?

At this point, we are utilizing RMB histopathology results for distinguishing cancer vs noncancer and 

 sending this tissue for biomarker or genomic testing, although that may be the future state, particularly as we learn more about the genomics of RCC. Recent data highlight the impact of determining histologic subtype at the time of RMB, which may have implications on progression.

 We are practicing in the era of precision medicine and personalized care. We are certainly seeing genomics in management of other urologic cancers, like prostate, and in some cases of advanced RCC. However, even for advanced RCC there is a lack of guidance or consensus about the use of genomic testing given the absence of definitive literature.

In your experience, if a patient undergoes RMB and ultimately proceeds to surgical extirpation, have you found the procedure, whether it be open or minimally invasive, to be more difficult due to the inflammation? If so, do you prefer to wait a set period of time before taking the patient to the operating room in hopes that the inflammation will subside?

I am not aware of any literature demonstrating that renal mass biopsy prevents future partial or radical nephrectomy or that it is associated with a higher complication rate. Generally, I would wait a minimum of 4 to 6 weeks from the time of biopsy to allow the patient time to heal. Anecdotally, if a patient develops a bleed with perinephric hematoma following biopsy, the tissue planes can be distorted and the surgery more challenging. In those patients, I may wait longer—months if possible—before proceeding with surgical extirpation.

For our audience, what would you say are the key take-home messages when contemplating percutaneous biopsy for patients with a SRM?

RMB is an important tool in the management of SRMs and should be utilized for patients in whom the results would impact management decisions, typically not the young and healthy or the old and frail. RMB should be performed following shared decision-making.

RMB may be utilized for differentiating benign from malignant tumors but less readily characterizes low grade from high grade. No biomarker or genomic testing is recommended following biopsy of SRMs, although with advancing technology and increasing knowledge of RCC, this is likely on the near horizon.

RMB can be safely performed in the interventional radiology suite or in the urologist’s office depending on physician comfort and experience and SRM characteristics.

Both CT and ultrasound guidance are effective in RMB, with the benefits of ultrasound being potentially improved characterization of endophytic lesions, more readily accessible technology, and cost savings.

1. Campbell S, Uzzo RG, Allaf ME, et al. Renal mass and localized renal cancer: AUA guideline. 

 2017;198(3):520–529. doi:10.1016/j.juro.2017.04.100

2. Crispen PL, Viterbo R, Boorjian S, et al. Natural history, growth kinetics, and outcomes of untreated clinically localized renal tumors under active surveillance. 

 2009;115(13);2844-2852. doi:10.1002/cncr.24338

3. Frank I, Blute ML, Cheville JC, et al. Solid renal tumors: an analysis of pathological features related to tumor size.

. 2003;170(6 Pt 1):2217-2220. doi:10.1097/01.ju.0000095475.12515.5e

4. Dave CN, Seifman B, Chennamsetty A, et al. Office-based ultrasound-guided renal core biopsy is safe and efficacious in the management of small renal masses. 

 2017;102:26–30. doi:10.1016/j.urology.2016.12.026

5. Dutta R, Okhunov Z, Vernez SL, et al. Cost comparisons between different techniques of percutaneous renal biopsy for small renal masses. 

 2016;30(suppl 1):S28-33. doi:10.1089/end.2016.0015

6. Posielski NM, Bui A, Wells SA, et al. Risk factors for complications and nondiagnostic results following 1,155 consecutive percutaneous core renal mass biopsies.

 2019;201(6):1080-1087. doi:10.1097/JU.0000000000000113

7. Finelli A, Cheung DC, Al-Matar A, et al. Small renal mass surveillance: histology-specific growth rates in a biopsy characterized cohort. 

2020;78(3):460-467. doi:10.1016/j.eururo.2020.06.053

Renal mass biopsy should be used for patients in whom results would impact management decisions.

The small renal mass and in-office biopsy: An overview

Karen Nash is a medical reporter and media consultant based in Monroeville, PA.

Urology Times reached out to 3 urologists (selected randomly) and asked them each the following question: Besides the expansion of telemedicine, how has the coronavirus disease 2019 (COVID-19) pandemic affected your practice?


“For a while, the hospital was not allowing elective surgeries, so we had to cancel procedures considered elective. A lot of patients wanted to stay home, and they canceled their appointments. There were some days we didn’t see a full day of patients, and a couple [of] days when we just closed the office because people wanted to stay home.

I respected that decision, …and worked on other projects so I could make good use of the time. That was probably March and April. By May, we basically had a full load of patients and it’s been very busy in the past few months.

I didn’t have any patients who suffered adverse consequences because of the delays. The urgencies we took care of just as we normally would. Some of the elective follow-up visits we postponed, then they came back a few months later and we’re getting caught up.

We’re taking it in stride. We don’t overbook to the point where we’re overwhelmed, and we’re not exhausting ourselves. We’re catching up.

As I said, none of my patients suffered because of the delays. The people who had true emergencies we took care of, and people who had things that could be electively postponed, we postponed, and now we’re getting back to normal.”

“I’m a transplant surgeon as well as a urologist. We took a big step back when we first had [COVID-19]–positive patients [as] we were concerned about 2 things: Seattle had some of the first documented cases in the US, so we put a moratorium on living-donor transplants which were elective procedures. Then we cut way back on deceased-donor transplants because we [had additional concerns]. First, we worried about immunosuppressing patients who might then be exposed to COVID-19. Second, a lot of our patients come from outside the Seattle area—Montana, Alaska, Idaho. We didn’t want to bring people from low-frequency COVID-19 places into Seattle. That had a pretty significant impact on the transplant side of our practice.

Any time a patient doesn’t get an organ, you can say there’s a detrimental effect, but if you need a kidney, you can live on dialysis. Nobody we’re aware of died because he couldn’t get a transplant.

We’ve restarted both programs. Now that we know more about COVID-19, we realize most transmission is not hospital-acquired; people are getting it in the community. So we feel safe having people come in and stay 3 to 5 days.

We’ve been fortunate; just 1 transplant patient died of COVID-19. She was 6 months out from transplant; she and her mom both contracted it in the community. They came into the hospital and succumbed to the disease. Most of our transplant patients have comorbidities—diabetes, hypertension, [or] they’re elderly––we’ve had no new transplant patients develop it.

We still did cancer surgery. There wasn’t a day I didn’t do something in the operating room, but my clinical practice was down by 50% to 60% for a couple months. We’ve gone back to close to our normal practice now. Volumes are just down about 20%.”

“The most obvious impact is that we all had a shutdown. I practice at the Minneapolis VA hospital. We’re continuing at reduced capacity. So that’s a major thing.

We have a more finite capacity and fixed resources at the VA. The government doesn’t just allow people to work overtime. Work stops at a certain time of day. We’re more restricted than the private sector, so there’s a backlog of cases. Surgery dates we can offer are somewhat in the distant future, making the backlog longer than is already usual at the VA.

I don’t think any patients were actually harmed. I think it’s more psychological. I’m talking mainly about prostate cancer. Once you’re diagnosed with any cancer and have chosen a certain path, it’s hard to understand that you have to wait another couple months to have it taken care of. Patients who were really urgent, however, [were taken care of]. It’s just the additional burden to waiting. We care for many older patients with comorbidities and they’re certainly worried about getting COVID-19.

We’ve had a few patients who had to cancel surgery because they developed COVID-19. Patients of mine developed [it] through community spread, not within the hospital, and they’ve all done OK.

We are catching up. Nobody I’m aware of is overwhelmed; we always have lots of work and stress, but it’s what we’re here for, isn’t it? It’s part of our social contract as physicians.”

"We’re taking it in stride. We don’t overbook to the point where we’re overwhelmed, and we’re not exhausting ourselves," says one urologist.

Besides the expansion of telemedicine, how has COVID-19 affected your practice?

Wayne Kuznar is a contributor to Urology Times.

Comprehensive genomic profiling shows that more than one-third of patients with upper tract and bladder urothelial cancer have tier 1-2 genomic alterations, defined as those that potentially can benefit from approved or investigational targeted therapies.

Using a modified European Society for Medical Oncology Scale for Clinical Actionability of molecular Targets, of 2463 patients with urothelial cancer who underwent comprehensive genomic profiling, 39% harbored ≥1 tier 1-2 genomic alterations, and 29% had a tier 3 genomic alteration “that provides a strong rationale for clinical trial consideration,” according to researchers led by Andrea Necchi, from Fondazione IRCCS-Istituto Nazionale dei Tumori, Milan, Italy.

, tumor tissue samples for comprehensive genomic profiling were obtained from 479 patients with upper tract urothelial cancer and 1984 with bladder urothelial cancer. The distribution of genomic alterations was as follows:

The most frequently altered genes in both groups were 

 = .04) alterations were significantly more common in bladder cancer, while 

 = .4) was more common in upper tract urothelial cancer.

 alterations were more significantly frequent in bladder cancer versus upper tract (21% vs 8%; 

 = .006) alterations were more common in upper tract urothelial cancer versus bladder cancer. 

 mutations were more common in upper tract urothelial cancer (21% vs 14%; 

 amplifications (0.4% vs 0.5%), rearrangements (3.3% vs 3.9%), and cases with multiple 

 alterations (1.3% vs 1.0%), occurred at similar rates between patients with upper tract urothelial and bladder cancer.

 alterations in upper tract urothelial cancer arose from a greater frequency of alteration in renal pelvis tumors versus urothelial tumors (9.5% vs 1.8%; 

 kinase fusions were observed in only 1% of patients, including 

 mutations and/or fusions were found in 2% of cases and were mutually exclusive with 

No significant differences in genomic alterations were observed between samples from the primary tumor and metastatic sites, except for the enrichment in primary site tumors of 

There were no differences in tumor mutational burden–high (≥20 mut/Mb) or microsatellite instability–high (MSI-H) status between primary tumor and metastatic sites, but upper tract urothelial cancer was enriched for MSI-H relative to bladder urothelial cancer (3.4% vs 0.8%; 

Genomic profiling of cell-free circulating tumor (ct)-DNA was performed for 126 patients. Overall, there was a 69% positive percent agreement between ctDNA and tumor tissue, and 71% of cases shared at least 1 mutation. This concordance decreased with greater time lapse between acquisition of the 2 specimens.

According to the authors, “This study provides an additional rationale for the routine incorporation of ctDNA assays in clinical trials and possibly in clinical practice, especially when a recently obtained tumor tissue sample is not available and/or to complement tumor tissue analysis.”

They continued, “Outside of clinical trials, our study findings have potential implications for the selection of erdafitinib [Balversa], a pan-

 inhibitor, which currently has accelerated approval by the US Food and Drug Administration for the treatment of platinum-treated advanced urothelial carcinoma. The potential roles of ctDNA as a putative prognostic biomarker and its ability to detect actionable genomic alterations in patients with and without available tumor tissue are experiencing growing interest among investigators.”

1. Necchi A, Madison R, Pal SK, et al. Comprehensive genomic profiling of upper-tract and bladder urothelial carcinoma [published online August 26, 2020]. 

Of 2463 patients with urothelial cancer who underwent comprehensive genomic profiling, 39% harbored ≥1 tier 1-2 genomic alterations.

Genomic profiling of urothelial cancers finds many with actionable alterations

Women with pelvic organ prolapse are more likely to have persistent overactive bladder (OAB) symptoms after transvaginal mesh surgery if they have a high versus low preoperative Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score (IPSS).

In a retrospective study of 102 patients who underwent transvaginal mesh surgery by a single surgeon, a preoperative IPSS storage subscore ≥10 was the most useful predictive factor for the persistence of preoperative OAB symptoms after surgery, reported Atsushi Otsuka, from Hamamatsu University, Hamamatsu, Japan, and colleagues in the journal 

“Interestingly, the present study demonstrated that the preoperative IPSS voiding subscore was also a useful predictive factor for the persistence of preoperative OAB symptoms after surgery although the predictive power did not exceed the preoperative IPSS storage subscore,” the authors wrote. “Although IPSS may not be familiar to gynecologists and urogynecologists, this minimally invasive self-reported questionnaire is useful in counseling preoperative pelvic organ prolapse patients with OAB symptoms.”

The investigators found that among the 54 women in the study with OAB, 20 (37%) had persistent symptoms after surgery, while 34 (63.0%) saw their symptoms disappear.

Among the 20 patients with persistent OAB symptoms postoperatively, 15 had an improvement in their OAB symptoms, while the remaining 5 had unchanged or worsened symptoms.

Total OABSS was significantly higher in patients with persistent preoperative OAB symptoms than in patients without persistent symptoms. On the IPSS, the total score, voiding and storage subscores, and individual component scores were significantly higher in patients with persistent preoperative OAB symptoms than in patients without them.

According to the receiver operating characteristics (ROC) analysis, the area under the curve (AUC) was 0.768 (95% CI, 0.640-0.896; 

 = .001) for total IPSS; 0.819 (95% CI, 0.694-0.944; 

 <.001) for IPSS storage subscore; 0.735 (95% CI, 0.596-0.873; 

 = .004) for IPSS voiding subscore; and 0.693 (95% CI, 0.550-0.835; 

The cutoff value for the IPSS storage subscore that indicated nearly equivalent sensitivity and specificity and that retained the greatest efficiency was 9.5.

The sensitivity of the IPSS storage subscore was 68.4% (95% CI, 43.5-87.4), the specificity was 91.2% (95% CI, 76.3-98.1), the positive predictive value was 81.3% (95% CI, 54.4-96.0), and the negative predictive value was 83.8% (95% CI, 68.0-93.8).

The sensitivity and specificity at the of the preoperative IPSS voiding subscore at the cutoff value of 7.5 was 60.0% and 70.6%, respectively.

“In contrast, several preoperative parameters (age, body mass index, parity, pelvic organ prolapse stage) had no significant impact on the persistence of preoperative OAB symptoms,” Otsuka et al wrote.

They continued, “An advantage of the present study is that minimally invasive self-reported questionnaires were used to determine predictive factors for persistence of preoperative OAB symptoms after pelvic organ prolapse surgery. Further, all patients underwent the same surgical procedure using transvaginal mesh by a single surgeon, reducing bias engendered by the type of vaginal surgery.”

Limitations of the research included the retrospective design and the absence of urodynamic study to evaluate detrusor overactivity and bladder outlet obstruction.

The percentages of patients who had relief of symptoms and persistent symptoms postoperatively “are in line with those generally reported for OAB symptom resolution following surgery for significant prolapse,” Alan J. Wein, MD, PhD (hon), co-director of the Voiding Function and Dysfunction Program at Penn Medicine, Philadelphia, wrote in an editorial comment on the research published in the 

. “It is generally agreed that parity and body mass index are not predictive for OAB symptoms after prolapse surgery,” added Wein.

1. Otsuka A, Watanabe K, Matsushita Y, et al. Predictive factors for persistence of preoperative overactive bladder symptoms after transvaginal mesh surgery in women with pelvic organ prolapse. 

. 2020;12:167-172. doi: 10.1111/luts.12299

. 2020;204(3):623-624. doi: 10.1097/JU.0000000000001180

“Although IPSS may not be familiar to gynecologists and urogynecologists, this minimally invasive self-reported questionnaire is useful in counseling preoperative pelvic organ prolapse patients with OAB symptoms," researchers write.

Preoperative bladder symptom score best predictor of transvaginal mesh surgery success 

A supervised 3-week test phase improves the success rate of sacral neuromodulation in patients refractory to first-line conservative treatment for urinary dysfunction.

In a prospective study of 90 patients with either overactive bladder (OAB) wet or dry or nonobstructive urinary retention (NOUR) who underwent the supervised 3-week test phase, 45 (82%) of 55 patients with a successful test phase and 1 year of follow-up achieved the primary measure of success at 1 year.

Success after 12 months was defined as 50% improvement in a key voiding diary variable combined with ≥80% satisfaction on visual analogue scale from 0 to 100% and no wish to receive alternate or add-on treatment.

 by investigators led by Sam Tilborghs, MD, PhD, from the Department of Urology at Antwerp University Hospital, Belgium.

The authors noted that sacral neuromodulation is currently offered as a staged procedure involving a test phase to evaluate its benefits, after which an internal pulse generator is implanted if early success is achieved. The optimal duration of the test phase is uncertain, as is how to guide and follow-up patients during the test phase.

Limiting the duration of the test phase may fail to identify patients who are considered to be slow responders, they added. According to the International Continence Society best practice statement, the duration of the test period varies from 7 to 21 days, with a low level of evidence.

“The present study clearly shows that test duration and reprogramming during the test phase increases the number of patients that benefit in the long term from sacral neuromodulation,” wrote Tilborghs et al. “Although chances of responding to sacral neuromodulation are inversely related to duration and reprogramming, our findings have clinical important implications for the test phase of sacral neuromodulation. During this supervised 3-week test phase, 42% (24 of 57) of the initial nonresponders after the first week of testing became successful candidates with proven durable success after 1-year follow-up. This method clearly allows more patients to benefit from sacral neuromodulation.”

The study included 48 patients treated primarily for OAB wet, 8 for OAB dry, and 34 for NOUR. To be eligible, patients had to be refractory to at least two different antimuscarinics and/or onabotulinum toxin A, and patients with NOUR had to have been on clean intermittent catheterization.

The supervised test included weekly patient contacts and reprogramming in case of insufficient clinical benefit. Voiding diaries were evaluated after the first week of stimulation, and if a 50% improvement from baseline was not achieved, electrode settings were retested and another configuration was programmed. This procedure could be repeated after the second test week. Patients with >50% improvement after 3 weeks proceeded to the second stage and IPG implant. Troubleshooting and reprogramming was possible at 1, 3, 6, and 12 months postoperatively.

After the 3-week test phase, 56 (62%) patients (49 women and 7 men) met the criteria for success and were implanted.

After the first week, 57 patients failed to reach the success criteria, after which another electrode configuration was tried. After the second test week, 29 were successful and therefore did not require reprogramming. Fourteen patients failed to achieve success after 3 weeks, leaving 15 (52%) of the 29 for definitive implant. The 28 patients considered nonresponders after the first and second weeks were reprogrammed for a second time, nine (32%) of whom met success criteria at the end of the 3-week test phase 3 and received a definitive implant.

Overall, 24 (43%) of the 56 patients who were considered successful at the final analysis needed 1 or 2 reprogrammings during the test phase, before reaching the 50% success criteria.

1. Tilborghs S, Borne SVd, Vaganée D, Win GD, Wachter SD. A supervised three weeks test phase in sacral neuromodulation with a one-year follow-up [published online July 27, 2020]. 

“The present study clearly shows that test duration and reprogramming during the test phase increases the number of patients that benefit in the long term from sacral neuromodulation,” researchers wrote.

Three-week test phase improves odds of success for sacral neuromodulation

Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

The FDA has granted fast track designation to EPI-7386, an oral, highly selective N-terminal domain inhibitor of the androgen receptor (AR), for treatment of metastatic castration-resistant prostate cancer (mCRPC) resistant to standard-of-care treatment, ESSA Pharma Inc announced.

ESSA Pharma is conducting a phase 1 trial (NCT04421222)

 trial of EPI-7386 that will evaluate the safety and tolerability of the agent and also examine its pharmacokinetic, biological, and anti-tumor effects.

"We are pleased with the FDA's decision to grant Fast Track designation for development of EPI-7386 to treat mCRPC patients resistant to standard-of-care treatments. This designation signifies recognition of the unmet medical need for new and effective treatments for this patient population. EPI-7386 may represent a promising novel treatment option for these patients and the designation offers the opportunity to interact more closely with the FDA during the development of EPI-7386,” David R. Parkinson, MD, Chief Executive Officer of ESSA Pharma, said in a press release.

®, J. Brantley Thrasher, MD, explained that EPI-7386 is part of a new class of AR-targeting compounds known as anitens.

“These compounds differ from currently available AR-blocking compounds because they bind to the N-terminal domain of the AR instead of the ligand binding domain. Due to its novel binding and mechanism of blocking the AR, it appears to work well in those patients who are progressing on current standard of care treatments,” said Thrasher, executive director of the American Board of Urology in Charlottesville, Virginia.

Added Thrasher, “I think this therapy will provide another agent in the armamentarium for mCRPC and will likely be used at first for those recalcitrant to standard therapies like enzalutamide [Xtandi] or abiraterone [Zytiga] but will quickly be tested to find out whether it works best in combination with one of these agents and what the best sequence of delivery will be.”

1. ESSA Pharma announces fast track designation granted by the FDA to EPI-7386 for the treatment of metastatic castration-resistant prostate cancer. Press release. Essa Pharma. September 14, 2020. Accessed Sept. 16, 2020. 

2. Oral EPI-7386 in patients With metastatic castration-resistant prostate cancer (EPI-7386). Updated September 16, 2020. Accessed September 16, 2020. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 

https://clinicaltrials.gov/ct2/show/NCT04421222

The FDA has granted fast track designation to EPI-7386, an oral, highly selective N-terminal domain inhibitor of the androgen receptor for treatment of mCRPC resistant to standard-of-care treatment.

FDA grants fast track designation for oral mCRPC agent

Fresh Perspective in Overactive Bladder

 discuss a recent Urology Practice study, “Impact of Mandated Opioid Online Training Course: Does It Impact Opioid Prescription Patterns for Outpatient Endoscopic Urologic Surgeries,” for which they served as study authors. Davuluri is a health care outcomes and research fellow at Weill Cornell Medicine Urology and clinical instructor of urology at NewYork Presbyterian Brooklyn Methodist Hospital, and Watts is assistant professor of urology at Montefiore Medical Center.


Meena Davuluri, MD, MPH, and Kara L. Watts, MD, discuss findings from a study published in Urology Practice.