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

Benjamin P. Saylor

The BlueWind RENOVA iStim System demonstrated safety in a cohort of 151 patients undergoing treatment for refractory overactive bladder.

Results from the OASIS trial, a prospective, interventional, multicenter, single-arm, open-label study were presented by senior author John Heesakkers, MD, PhD, of Radboud University Medical Centre in Njimegen, the Netherlands.

The study enrolled women with urgency incontinence. Patients had to have at least 1 urinary urgency incontinent episode per day for 5 days. Mean age was 58.9 years.

“The device is implanted in the lower leg during a minimally invasive procedure in which it is secured superficial to the tibial neurovascular bundle, just below the fascia. The implant is activated [approximately] 4 weeks after implantation,” wrote the authors. Patients are instructed to apply the wearable unit and then preform daily stimulation treatments at home for a period of 30 to 120 minutes per day. The investigators collected voiding diary data, quality of life questionnaires, and patient satisfaction questionnaires at 6, 12, 24, and 36 months after device activation and compared these data with baseline. Primary end points were efficacy, which was defined as patients having at least a 505% reduction in urgency urinary incontinence episodes at 6 months, and safety, characterized as incidence of device and procedure-related adverse events at 12 months post activation.

A total of 151 subjects have undergone implantation in 9 centers in Europe and 14 in the US. Mean baseline of 4.72 UUI per day and 10 voids per day were reported. Of the cohort, 151 patients have 6 months’ follow-up and 76 have 12 months’ follow-up. The investigators report that no device or procedure-related serious adverse events have occurred. A total of 144 patients had adverse events that were adjudicated, of which 7 (4.8%) had mild and 4 (2.8%) had moderate device or procedure AEs.

In his concluding remarks, Heesakkers said the RENOVA iStim offers single-stage therapy and a battery- and recharge-free implantable component.

1. Sutherland S, Padron O, Benson K, et al. OASIS pivotal trial to evaluate the safety and efficacy of the RENOVA iStim system for the treatment of women with OAB. 

2022;207(5S):e1043.doi:10.1097/JU.0000000000002670.05

Articles

The investigators report that no device or procedure-related serious adverse events have occurred.

RENOVA iStim System shows safety in refractory overactive bladder

A more aggressive collagenase clostridium histolyticum (CCH, Xiaflex) injection/traction protocol is associated with improved penile curvature in men with Peyronie disease.

The research was presented during a podium presentation at the 2022 American Urological Association Annual Meeting in New Orleans, Louisiana.

The investigators’ injection protocol has evolved over time and comprises injection of 0.9 mg of CCH in 0.7 mL of saline into approximately 15-20 sites around the point of maximal curvature. These injections are performed on subsequent days, and very aggressive modeling encompassing 10-15 lbs of force is performed with the second injection. At 24 to 48 hours after the second injection, patients are counseled to begin RestoreX traction for 30 to 60 minutes daily. The investigators advised aggressive manual modeling to continue for at least the first week after injection. They performed a descriptive analysis to review outcomes.

The study cohort consisted of 438 men who underwent at least 1 series of CCH and had baseline and follow-up curve assessment data available. The patients had a mean age of 55.8 years, mean Peyronie disease duration of 32 months, and 64-degree median baseline composite curvature. The investigators reported that, using the definition of most recent curve assessment, mean composite curve improvements were 27.1 degrees (41%) with the more aggressive technique vs 17.8 degrees (24.6%, 

<. 001). In men who completed all 8 injections or who stopped early due to satisfaction, mean improvement seen was 36.4 degrees (59%) vs 19.8 degrees (30.5%, 

<. 001). Erection function, as assessed by the International Index of Erectile Function-Erectile Function Domain, was similar to baseline.

Discussing the findings, study co-author Landon Trost, MD, said, “The study wasn't real surprising, but it was more so when we started implementing it that you notice it right away in clinic, because we'd have patients who would send us pictures after the fact. And we had some that would get a single injection and were fully straight, which we'd never had before. And so we immediately knew that there was something to this.” Trost is the director of the Male Fertility and Peyronie’s Clinic in Orem, Utah.

Trost commented that although the aggressive technique has become the standard of care in his own practice, it should not be considered so elsewhere yet.

“We’re a real high-volume Peyronie [disease] center, and so we can get numbers a little bit more rapidly. But really, you need that external validation before you start having everybody do it,” Trost said.

Trost said his group is currently conducting a randomized trial of the technique in patients who had prior treatment failure with CCH.

“The preliminary data…is looking very similar to men who've never had any treatment before. It just emphasizes how technique is 1 important aspect of successful treatment with the drug,” Trost said.

Both Trost and first author Alissa Tyler, RN, emphasized the importance of technique in administering CCH.

“With proper training and proper technique, there really can be drastic changes that can be made without having to do a surgical intervention,” commented Tyler, a registered nurse at the Male Fertility and Peyronie’s Clinic.

1. Tyler A, Green B, Savage J, et al. Improved Peyronie's disease curvature outcomes using a more aggressive collagenase technique. 

. 2022;207(5S):e409. doi:10.1097/JU.0000000000002565.01

“With proper training and proper technique, there really can be drastic changes that can be made without having to do a surgical intervention,” commented first author Alissa Tyler, RN.

Aggressive CCH technique is linked to improved curvature in Peyronie disease

Researchers from the University of British Columbia, Vancouver have developed an open source, non-invasive, and inexpensive device for automatic hematuria monitoring in continuous bladder irrigation (CBI).

The hematuria monitor (HM) was discussed in a late-breaking abstract at the 2022 American Urological Association Annual Meeting in New Orleans, Louisiana.

In discussing the background for the study, co-author Alireza Habibi, a medical student at the University of British Columbia, explained that although CBI is a common intervention following endourologic surgery, it is reliant upon subjective assessment and adjustments and is labor intensive. In addition, assessment of grade of hematuria is user dependent.

The investigators reported that the HM utilizes the Arduino open-hardware platform. Full hardware specifications for all components can be found online, and the instructions are available at www.github.com/malyalar/CBI-monitor. They include CAD files, files for enclosures, circuit schematics and layouts, source code, and data from validity analysis.

“The spectral sensing device is a 3D printed shroud where a white LED is mounted opposite to a AS7262 spectrophotometer module (AMS). Incident light is passed through a CBI catheter outflow tube clipped inside the shroud, resulting in a reading at the photodiode proportional to the hematuria in the tube,” wrote the authors.

The HM measures flow rate via rate-of-change calculation at a load cell. The catheter outflow bag is mounted at the load cell. A small TFT screen delivers telemetry. The investigators conducted testing using 5 serial dilutions of pigs’ blood in normal saline that encompassed a full range of hematuria grades and sealed within portions of catheter outflow bag tubing.

The investigators reported that the HM continuously monitors flow rate, estimates blood concentrations, and outputs alarms in the event of obstruction in laboratory settings. It can also display an alarm based on estimates of hematuria grade and flow rate adequacy. A limitation of the system is that in its current form, it does not adjust the flow rate of CBI automatically. The system costs $35 CAD in its most basic form, and no special skills or tools are required to build it.

“In testing, the HM achieved a correlation coefficient of 0.97, 

 = .006 for its estimations of hematuria against 5 known serial dilutions (in triplicate) of pig’s blood ranging from 0.05 mL to 0.3 mL in 10 mL saline,” wrote the authors.

In his closing remarks, Habibi said his group plans to conduct a study looking at agreement between measurements, with the goal of improved patient outcomes and CBI management standardization.

1. Malyala R, Habibi A, Phillips D, et al. An open source, non-invasive, and inexpensive assembly for automatic hematuria monitoring in continuous bladder irrigation. 2022;207(5S):e1043. doi:10.1097/JU.0000000000002670.06

Open source device monitors hematuria during continuous bladder irrigation

A combination of extracorporeal shock wave lithotripsy (ESWL) and extracorporeal physical vibration lithotripsy was found to be safe and efficacious in patients with ureteral stones, according to a study presented at the 2022 American Urological Association Annual Meeting in New Orleans, Louisiana.

Using the random number table method, the investigators, led by Han Yang, divided 60 patients with ureteral stones who visited the investigators’ institution between June 2019 and November 2020 into a test group and a control group. Each group included 50 cases. Patients in the control group underwent extracorporeal shock wave lithotripsy, whereas the test group received ESWL combined with extracorporeal physical vibration lithotripsy. The investigators compared lithotripsy rate, completion time, pain relief time, hospitalization time and complications between the 2 groups.

At 2, 3, and 5 weeks after surgery, the stone removal rate was higher in the test group vs the control group (

< .05). In addition, stone removal time, pain relief time, and hospitalization time were shorter in the test group compared with the control group (

< .05). Finally, patients in the test group had a lower incidence of complications compared with the control group (

“The combination of extracorporeal shock wave lithotripsy and extracorporeal physical vibration lithotripsy can promote stone expulsion, shorten stone evacuation, pain and hospitalization time, and has high safety,” the authors wrote in their conclusion.

Discussing the abstract in a video interview with Urology Times, Amy E. Krambeck, MD, said the study was “interesting, mainly because this concept has been around for an extremely long time… They found that the stone free rates at 2, 3, and 5 weeks after surgery were significantly higher in the vibration therapy group vs shockwave alone. They also found fewer complications in the vibration therapy group versus shockwave or loan,” said Krambeck, professor of urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

1. Yang H, Li X, Wang K. Effect of extracorporeal shock wave lithotripsy combined with extracorporeal physical vibration lithotripsy in the treatment of patients with ureteral calculi. 

. 2022;207(5S):e1042-1043. doi:10.1097/JU.0000000000002670.04

At 2, 3, and 5 weeks after surgery, the stone removal rate was higher in the test group vs the control group (P < .05).

Benjamin P. Saylor

Articles

RENOVA iStim System shows safety in refractory overactive bladder

Aggressive CCH technique is linked to improved curvature in Peyronie disease

Open source device monitors hematuria during continuous bladder irrigation

Combination ESWL and extracorporeal physical vibration lithotripsy found safe, efficacious