Is it time to offer True Minimally Invasive Treatments (TMIST) for BPH?

[madman]

Introduction:​

The options for treating benign prostatic hyperplasia (BPH) beyond medication and traditional transurethral surgery continue to expand. Undesirable side effects to medication and surgeries have driven interest toward minimally invasive surgical therapies (MISTs), including convective water vapor ablation (Rezum) and prostatic urethral lift (UroLift). While these treatments can be performed outside of the operating room, they do require special equipment and the use of rigid cystoscopy. A new class of treatments, which utilize no special equipment beyond a flexible cystoscope are emerging, the first of which, the temporary implantable nitinol device (iTind) is already FDA approved.

Materials and methods:​

A comprehensive review of the literature using PUBMED, EMBASE, Scopus focused on the two commercially available MISTs, Rezum and

UroLift was performed. Additionally, we evaluated the existing literature for the novel iTind.

Results:​

UroLift and Rezum have demonstrated significant improvements in validated questionnaires such as IPSS and IPSS QoL. They generally maintain erectile function (IIEF) and ejaculatory function (MSHQ). The short-term recovery seems to slightly favor UroLift, while re-treatment rates seem to favor Rezum. The iTind also appears to improve subjective and objectives outcomes, though longer-term follow-up is still maturing.

Conclusion:​

The currently available MISTs have changed the way we treat BPH, offering a middle ground for men between oral medial therapy and more invasive transurethral surgery. While these MIST treatments require specialized and costly equipment, the proposed new category, the True Minimally Invasive Surgical Therapy, or TMIST, offers an off-the-shelf, affordable and comfortable solution for men suffering from LUTS secondary to BPH.




The ever-increasing impact of benign prostatic hyperplasia (BPH) is truly a global phenomenon. An aging population and improved access to 21st-century endoscopic care mean more men will be diagnosed and treated for BPH. We are all too familiar with the dogma of watchful waiting, medical therapy, and finally surgical intervention. Depending on where you live in the world, the options are various. Transurethral resection of the prostate (TURP) has been the mainstay of management for nearly a century. TURP and its laser alternative offspring offer durable outcomes with ever-increasing safety profiles. However, the sheer number of men requiring surgical intervention vastly outpaces our operative resources. Medical therapy has alleviated some of the demand for surgery yet many men remain dissatisfied with both long-term medications and current surgical choices. Not to mention, many men managing LUTS with medical therapy may develop, silently, long-term permanent damage to their bladders from chronic bladder outlet obstruction. The burden of taking pills daily for life, along with the sexual (erectile, libido, and ejaculatory) side effects is off-putting to numerous men. Surgery is no better, with the need for general anesthesia, recovery off work to convalesce, and the inherent risks of complications including urinary incontinence, bleeding, and permanent ejaculatory dysfunction.

In light of such BPH treatment shortcomings, we have witnessed the introduction of minimally invasive surgical therapies (MISTs) in the past 5 years. While the interest of an office-based therapy has been sought after with earlier iterations (i.e TUNA, TUMT), we currently have two commercially available, FDA and Health Canada approved and guidelines endorsed options, UroLift (NeoTract/Teleflex Inc., Pleasanton, CA, USA) and Rezum (Boston Scientific Corp., Marlborough, MA, USA). Both technologies alleviate the burden on operating room resources as they can be performed in other settings without the need for general anesthesia.

Prostatic urethral lift (PUL) or UroLift uses intraprostatic implants to retract obstructing prostate tissue inward towards the capsule. Numerous studies have been conducted since 2011, when Woo et al, first described their initial experience.1 In the LIFT study, a prospective, randomized, sham-controlled, double-blinded clinical trial, 140 men underwent UroLift implantation, while 66 had sham rigid cystoscopy. The most recent 5-year follow-up reported improvements in IPSS from 22.3 to 14.5 and improved IPSS QoL from 4.6 to 2.5. Qmax showed modest improvement from 7.9mL/s to 11.1 mL/s. Notably, there were no de novo cases of erectile or ejaculatory dysfunction.2 The surgical retreatment rate at 5 years in this cohort was 13.6% and there were 13 patients who had implants removed from the bladder. The sham group was allowed to cross over and their 2-year outcomes (IPSS, IPSS QoL, Qmax) were similar to the treatment group with 10% requiring retreatment.3 The BPH6 study in 2017 was a randomized clinical trial comparing UroLift to TURP. The TURP group experienced greater improvements in IPSS and Qmax, however, the UroLift group had superior recovery and ejaculatory function preservation. UroLift did not improve post-void residual (PVR), whereas TURP did experience reduced PVR.4 The recent MedLift study examined the application of UroLift in patients with obstructing median lobes, who would have been excluded from the original LIFT study. This modified technique to treat the median lobe resulted in durable improvements in IPSS, IPSS QoL, Qmax, and a retreatment rate of 2% at 1 year.5

Convective water vapor energy (WAVE) ablation or Rezum uses radiofrequency to heat water into steam which is injected transurethrally into the obstructing prostate tissue resulting in cell death and volume reduction. The first prospective study in 2016 of 65 men showed significant improvements lasting up to 2 years with no changes in ejaculatory or erectile function. Retreatment occurred in only one patient.6 The pivotal Rezum II prospective, multi-center, double-blinded randomized controlled trial included 135 treated me and 61 sham controls. The outcomes of the cohort, which has been followed for 4 years, was published in 2019.7 McVary et al showed significant improvements in IPSS (21.4 to 11.4), IPSS QoL (4.3 to 2.3), Qmax (9.5 mL/s to 13.7 mL/s), and a surgical treatment rate of 4.4%. There were no cases of de novo erectile dysfunction and transient anejaculation in 4 patients which resolved after 3 months. A subsequent series by Darson et al reported similar improvements in 131 men with a retreatment rate of 3.1% at 1 year.8 Mollengarden et al reported on 129 men with 6 months follow-up.9 Again, similar consistent improvements were seen with a 2.3% retreatment rate. Ejaculatory and erectile dysfunction were each reported at 3.1%.

Not to be misunderstood or misinterpreted, we believe MISTs are currently excellent alternative BPH options for many urologists and their patients around the world. Thus far, they have treated countless men, allowing them to come off of medications or avoid more invasive surgeries. They play an important and rapidly growing role in the procedural management of BPH, a role that is here to stay. However, we need to rethink what a MIST is and whether we can offer something that changes the paradigm of BPH treatment. Herein, we would propose a novel concept, the TMIST – True Minimally Invasive Surgical Therapy.