Minimally invasive treatments grab BPH spotlight

January 30, 2019

Minimally invasive surgical options took front and center in 2018 when the AUA published its revised guideline on the surgical management of male lower urinary tract symptoms secondary to BPH.

Minimally invasive surgical options took front and center in 2018 when the AUA published its revised guideline on the surgical management of male lower urinary tract symptoms secondary to BPH.

The revised guideline includes recommendations for the UroLift and Rezum devices, which received FDA clearance in 2013 and 2015, respectively.

“In patients who have bothersome symptoms and have prostates of 30 to 80 grams, the UroLift and Rezum are reasonable options,” said guideline co-author Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai in New York and director of Mount Sinai’s Benign Urologic Diseases and Men’s Health Program.

Aquablation and prostate artery embolization (PAE) are newer, promising BPH treatments, but the guideline authors suggested there were not enough data at the time of publication to recommend them for clinical practice. Prostate artery embolization should be performed for the time being in a clinical trial rather than in practice, according to Dr. Kaplan.

“Most of the new technologies in BPH occupy a position between drugs and established surgery, such as transurethral resection of the prostate (TURP) and laser treatments,” said urologist Peter Gilling, MD, professor of surgery at the University of Auckland in New Zealand. “Durability is an important issue for each, but antegrade ejaculation is usually preserved.”

Urologists don’t remove as much tissue with the minimally invasive options as with TURP, so there’s a recurrence rate and urologists should discuss that with patients, according to Dr. Kaplan.

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Recognizing minimally invasive options for BPH symptom improvement is a move in the right direction for patients because medical management might not be in patients’ best interest, according to Art R. Rastinehad, DO, associate professor of urology and radiology at the Icahn School of Medicine at Mount Sinai.

“Is giving BPH patients an alpha-blocker the right thing to do? These alpha-blockers can cause side effects: dementia, depression. And other treatments we use can alter men’s hormone levels and cause changes in mood [and] decreased libido,” Dr. Rastinehad said. “With minimally invasive treatments, men can be off their medications and get great results.”

Next: UroLift SystemUroLift System

The prostatic urethral lift (UroLift System) essentially uses a staple that is inserted through a man’s urethra with a cystoscope. It opens the channel of the urethra, pushing the side lobes of the prostate laterally, according to Claus G. Roehrborn, MD, professor and chair of urology at the UT Southwestern Medical Center in Dallas, and an author of the revised AUA guideline.

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“This is accomplished with a special delivery device by which the staple is basically applied through the wall of the urethra and the prostate to the capsule. It’s done with a certain pressure or compressive factor so that the side lobe of the prostate is compressed, as if you literally put a staple through it,” Dr. Roehrborn explained.

The number of staples needed depends on prostate size. For a man with a 40- to 50-gram prostate, UroLift treatment requires between two and six staples-usually three on each side, Dr. Roehrborn said.

“It is expensive as each staple is a separate device and sometimes many are placed,” Dr. Gilling said.

Researchers tested the UroLift device in a randomized trial against placebo, showing relative success in the short term, then followed the cohort of men 5 years. They found UroLift patients had symptom improvement of about 10 points and a flow rate improvement of 3 to 4 mL per second (Can J Urol 2017; 24:8802-13).

“Flow rates are modestly improved but noticeable immediately, and general anesthesia is usually employed,” Dr. Gilling said.

Dr. Roehrborn does the UroLift as an outpatient procedure and said patients usually can resume normal activities within 3 days.

“Eighty percent of patients don’t require a catheter for drainage, and they’re able to urinate fine right after the procedure,” Dr. Roehrborn said. “UroLift treatment with staples preserves ejaculation in about 98% to 100% of patients.”

The FDA approved UroLift for men with prostate enlargement with BPH, both with side lobe enlargement and middle point or intravesical lobe, for which there is a special technique to apply the staples.

Read: TURP duration linked with complication rate

“The AUA guideline recognizes it for treatment of men’s prostates with side lobe enlargement but not for the middle lobe enlargement. The AUA guideline [authors] feel that there is not enough data yet for the indication for the middle lobe,” Dr. Roehrborn said.

Next: Rezum SystemRezum System

Water vapor thermal therapy (Rezum System) is a type of steam therapy used to treat BPH.

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“It injects steam in the prostate, also with the cystoscope through the urethra, through a needle,” Dr. Roehrborn said. Energy generated by the steam destroys prostate tissue.

“It’s pretty simple but it’s actually very effective, and since it’s water or steam there’s no real side effect other than just the injection with the needle,” Dr. Roehrborn said. “This treatment has 3-year data from a randomized controlled trial. It results in a 10-point improvement in the symptom score and in a 4- to 6- mL per second improvement in the urinary flow rate [Urology 2018; 111:1-9].”

Rezum treatment preserves ejaculation in 90% to 95% of patients.

The procedure can be done in the office in some cases but is painful and requires sedation, according to Dr. Gilling.

Dr. Roehrborn said he often performs Rezum treatment using a prostate block and lidocaine. It can be an insurance issue if patients need general anesthetic because the Rezum procedure is far more cost-effective to do in an office setting, he said.

“Significant improvements in symptoms can take 4 to 6 weeks to achieve. Improvements in urinary flow are modest at best,” Dr. Gilling said.

Nearly all patients require a catheter in the days following the procedure because of edema, according to Dr. Roehrborn.

Read - BPH procedures and med use: Two sides of a coin

The FDA approved Rezum for prostates with side lobe enlargement up to 80 grams and middle lobe enlargement because the steam can also be injected into the middle lobe. The AUA guideline recommends it for treatment of middle and side lobes.

Next: Aquablation/AquaBeam SystemAquablation/AquaBeam System

Aquablation using the AquaBeam System is a robot-assisted technique involving tissue ablation with a waterjet. Tissue removal occurs acutely and rapidly, according to Dr. Gilling.

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Aquablation requires that patients be treated in the operating room with general anesthesia.

“The treatment is done through the urethra with a cystoscope that is then lined up with an ultrasound bulb in the rectum. After the treatment plan has been developed, the machine basically pushes water with very high pressure into the prostate, and that high pressure destroys the prostate tissue in the area that was planned under ultrasound guidance,” Dr. Roehrborn said.

“Aquablation was approved by the FDA on the strength of a study comparing it to TURP. And outcome by outcome it matched or excelled above and beyond the efficacy of TURP, which is after all our standby treatment,” he added.

Researchers compared Aquablation to TURP in patients with prostates between 30 and 80 grams, according to Dr. Roehrborn.

“And even this water ablation treatment preserves ejaculation in a high percent of patients-far more than the TURP,” Dr. Roehrborn said.

Patients require a catheter at least overnight, and hemostasis can be an issue, according to Dr. Gilling.

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Aquablation’s recent data wasn’t ready for review when the AUA panel developed its guideline, so it is not yet recommended, Dr. Roehrborn said.

Next: Prostatic artery embolizationProstatic artery embolization

Researchers have found that PAE has about the same efficacy at 9 months to 2 years post treatment as TURP, although it takes a while for embolization patients’ prostates to shrink. As a result, TURP patients will urinate better in the short term, according to Dr. Rastinehad.

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“We get great results, similar to the Rezum treatment, in these patients. And we are treating a much broader population of men with 40-gram prostates to 750 grams, the largest we’ve ever done,” said Dr. Rastinehad, who is dual fellowship trained in interventional radiology and urologic oncology and has been doing PAE cases and research for almost 17 years.

“Prostate artery embolization hasn’t gotten the attention it deserves because urologists haven’t adopted it,” Dr. Rastinehad said. “The guidelines call it investigational despite significant data on the approach and the FDA’s approval.”

Dr. Rastinehad performs PAE using a trans-radial approach. “So people can come into our angiography suite, we obtain radial access, and they can go home the same day with just a Band-Aid on their wrist,” he said. “We do the entire procedure without a Foley catheter in place. Therefore, a lot of patients don’t have any burning or discomfort after the procedure.”

One catheter option for PAE, the Sniper Balloon Occlusion Microcatheter, is unique in that users can inflate it to occlude the artery and possibly change direction of the blood flow, redirecting it toward the prostate, according to Dr. Rastinehad.

Dr. Rastinehad performs PAE with sedation but said it can also be done using a local anesthetic.

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“It’s a useful technique for patients who are not great candidates for anesthesia,” he said. “And it’s especially good for patients that are out of the normal size limits with respect to UroLift and Rezum-for patients with a prostate that’s bigger than 100 grams. We’re able to do large prostates with ease, without the complications or risks associated with major surgery.”

Next: Additional guideline updatesAdditional guideline updates

Among other updates to the AUA guideline: The panel no longer recommends transurethral needle ablation because of concerns about long-term data. But it gave a higher recommendation to prostate ultrasound prior to treatment with newer minimally invasive therapies to determine prostate size and configuration.

Other devices for BPH symptom treatment are in the pipeline, including stents and radiofrequency options, according to Dr. Gilling.

In the meantime, Dr. Kaplan said he’s confident enough in the newer therapies to have one, himself, if needed.

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“If I were a person who needed such a therapy, I would not even use medical therapy anymore. If I had an enlarged middle lobe, I would have the Rezum. If not, I would have the UroLift,” Dr. Kaplan said.

 

Dr. Roehrborn receives research support from and is a consultant for NeoTract (now Teleflex), NxThera (now Boston Scientific), and PROCEPT BioRobotics. Dr. Gilling is a study investigator for PROCEPT BioRobotics.