В этой статье вы узнаете:
New methods for the treatment of prostate adenoma are minimally invasive surgical methods for the treatment of prostatic hyperplasia in Germany, which in recent years have become the undisputed “gold standard”. Their common use is due, on the one hand, to the general tendency in medicine to reduce invasiveness and surgical trauma due to technological development, and on the other hand, to the desire of patients and doctors to shorten hospital stays and postoperative periods, and to minimize retrograde ejaculation.
The development and application of minimally invasive treatments is a dynamic area in experimental and clinical medicine, leading to the emergence of methods with varying degrees of effectiveness and safety. The purpose of this review article is to present and compare both proven and not yet fully proven methods, as well as those whose use and application are known only in certain centers or countries around the world.
Several literature reviews on minimally invasive treatments for benign prostatic hyperplasia (BPH) have been published over the past few years, driven by interest and technological advances in surgical systems and devices. Transurethral resection of the prostate (TURP) and classical adenomectomy have historically been well-established techniques with significant improvements in functional outcomes, but are also associated with known intraoperative complications and risks. Various methods have been described, some of which are still in clinical trials, including on animal models, with tools and equipment already available on the market. Some of these techniques are performed in just a few minutes as outpatient procedures with local anesthesia or oral sedation.
Transurethral resection of the prostate (TUR)
The presentation of the method, although well known and proven effective for the treatment of BPH, is intended to provide a basis for comparison with other innovative minimally invasive techniques in BPH surgery.
Mechanism of action: TUR removes prostate tissue from the transition area of the prostate gland.
Efficacy: In results reported from 20 retrospective clinical cases with 5-year follow-up, TURP resulted in a significant improvement in uroflowmetry peak flow rate — Qmax (+162%), significant improvement in International Prostate Symptom Index (IPEI) score ( -70%), improved quality of life (QoL) (-69%) and reduced residual urine (-77%) . TUR provides long-lasting results without comparable longevity data from any other minimally invasive technique.
Long-term failure is associated with the development of detrusive underactivity rather than re-development of benign prostatic obstruction .
Tolerance and safety: analysis of the results of complications, summarized on the basis of randomized clinical observations, showed: bleeding requiring blood transfusion — 2% (0-9%), TUR syndrome — 0.8% (0-5%), acute urinary retention — 4.5% (0-13.3%), clot retention 4.9% (0-39%) and urinary tract infections 4.1% (0-22%) .
Long-term complications include: urinary incontinence (2.2%), urinary retention and urinary tract infections, bladder neck contracture (4.7%), urethral stricture (3.8%), retrograde ejaculation (65.4%) and erectile dysfunction (6.5%).
The cost of transurethral resection of the prostate (TUR) in Germany is from 8800 Euro with a specialist included in the TOP-3 in Germany.
Urethral prostate lift (PUL), UroLift
This method is not suitable for the treatment of malignant tumors (cancer) of the prostate!
PUL is the transurethral placement of small, permanent intraprostatic implants (consisting of nitinol, polypropylene, and stainless steel) to remove obstructive lateral lobes of the prostate from the urethral lumen.
This is a way to treat benign prostate obstruction without blocking the tissue. Case-reported clinical trials reported improvements in International Prostatic Symptom Index (IPCC) scores of more than 52%, with a mean improvement of 9.22–11.82.
The procedure has been proven to achieve long-lasting results: up to 3 years .
One of UroLift’s most preferred strengths is its ability to respond to lower urinary tract (STD) symptoms of BPH while preserving sexual function — both erectile and ejaculatory. This is an attractive treatment option for men who want to avoid the side effects and complications of long-term drug therapy (α-blockers or 5α-reductase inhibitors) and standard BPH surgery .
Patients recover quickly after surgery and can return to normal physical activity.
In September 2013, the US Food and Drug Administration approved UroLift. In September 2015, the UK National Institute for Clinical and Health Excellence also approved UroLift as an effective, safe and cost-effective treatment for use in the UK healthcare system for routine use.
A limitation of the clinical use of UroLift is that it was originally recommended for the treatment of lateral lobe obstruction only.
However, a study is currently underway to evaluate the safety and effectiveness of UroLift in patients with enlarged mid-prostate lobes.
The cost of a urethral prostate lift in Germany is 4500 Euro
Treatment by convection evaporation of water: Rezum system
This method is not suitable for the treatment of malignant tumors (cancer) of the prostate!
The Rezum system uses convection energy from water vapor to ablate prostate tissue. This is a minimally invasive surgical treatment that can be performed on an outpatient basis or in a hospital using oral pain medications and is applicable to all areas of the prostate gland, including the middle lobe.
Results from a pilot study of 65 men showing safety and efficacy of the Rezum system showed statistically significant clinical improvements at 1, 3, 6 and 12 months for ISPS (6.8, 13.4, 13.1 and 12.5 reductions, respectively) and Qmax (increases from 2.0, 4.7, 4.3 and 4.6 ml/s, respectively). At month 12, there was a 56% improvement in IPSI (p < 0.001), a 61% improvement in quality of life, and an 87% improvement in Qmax (p < 0.001). The procedure is safe, with an acceptable side effect profile. Sexual function is preserved, and most side effects are short-lived and related to the endoscopic equipment.
Nuclear magnetic resonance research has shown that convection evaporation technology creates thermal damage in prostate tissue, which then completely recovers within 3-6 months after treatment. The result of this treatment is a 30% reduction in the total volume of the prostate and the transition area.
Implantation of a temporary nitinol device (TIND)
This method is not suitable for the treatment of malignant tumors (cancer) of the prostate! And also, it has not collected a sufficient number of positive statistics and, therefore, is rarely used in Germany.
TIND is a nickel-titanium alloy or nitinol device that is inserted transurethrally into the prostatic urethra to apply external pressure to the obstructing prostate lobes for 5 days and then removed. Its purpose is to alleviate PSD due to BPH.
The results of the first prospective clinical trial in humans were described by Porpiglia et al. . Thirty-two patients (age >50 years) with PDS due to BPH, MPSI >10, ≤12 mL/s, and prostate volume <60 mL received TIND. Implantation is carried out with light sedation into the bladder neck and into the prostate urethra using a rigid cystoscope for 5 days.
The reported mean operative time was 5.8 minutes, and the mean postoperative stay was 1–2 days. All devices were removed 5 days after outpatient implantation. Four (12.5%) complications were noted: one (3.1%) urinary retention, one (3.1%) temporary incontinence due to device migration, one (3.1%) prostate abscess, and one (3.1%) %) urinary tract infection. At 12 months, the median MPSI was 9 (range 7–13), the median quality of life was 1 (IQR 1–2), and the median Qmax was 12 mL/s. The average IMEI improvement over baseline is 45% and Qmax is 67%. No patients requiring medical therapy or surgery for BPH were enrolled in the study at 12 months. In conclusion, TIND implantation was found to be a feasible and safe minimally invasive treatment option for STDs due to BPH. Functional results are encouraging and the treatment significantly improves patients’ quality of life . However, further studies are needed to confirm these results and evaluate the duration of the procedure beyond 12 months.
Aqua ablation, AquaBeam system
Aqua ablation is a new minimally invasive therapy for the treatment of BPH. Under real-time ultrasound guidance, AQUABEAM technology allows surgical planning and mapping to achieve safe prostate resection with high-speed water flow.
Aquablation is a relatively automated procedure with few side effects, but requires general anesthesia. The purpose of high-velocity saline is to selectively stimulate ablation of prostate tissue while preserving collagen structures — blood vessels and capsule. The extent and depth of ablation were previously determined using endoscopic and transrectal ultrasound. Histological evaluation at week 6 reveals normal cellular architecture and complete re-epithelialization of the resulting cavity. Preliminary results indicate that prostate aquablation is technically feasible with a high safety profile comparable to other technologies for the treatment of BPH. Advantages of this technique include reduced resection time compared to other endoscopic techniques, as well as the ability to maintain sexual function .
The cost of Aqua ablation in Germany is 6500 Euro
This method is not suitable for the treatment of malignant tumors (cancer) of the prostate!
Histotripsy is a non-thermal, non-invasive, pulsed ultrasound technology that results in ablation of tissue within a target volume.
It has been studied in several animal studies and clinical trials are currently underway in humans. Darnell and others reported histological changes in the prostate gland after treatment with histotripsy in eight dogs. In vivo, histotripsy in dogs resulted in a 31% reduction in prostate volume and the development of a limited inflammatory and fibrotic response.
Although this technology had many difficulties in animal models, it has undergone technical improvements. The results of the first human studies are awaited.
Intraprostatic injections
Prostate injections with various agents are an attractive and challenging treatment due to the possibility of local anesthesia.
Injection with NX-1207
NX1207 (Nymox Corporation, Quebec, Canada) is a drug that is administered by ultrasound-assisted transrectal intraprostatic injection. The substance leads to a decrease in the volume of the prostate gland and an improvement in symptoms. However, the number of patients is small and the NX1207 treatment is currently still experimental. In November 2014, further development of NX1207 as an effective treatment for BPH was discontinued.
Botulinum toxin injections
Botulinum toxin is a neurotoxin produced by the bacterium Clostridium botulinum. It inhibits the release of acetylcholine and other neurotransmitters from nerve endings. Botulinum toxin, particularly botulinum toxin type A (BoNT-A), has been used since the 1970s to reduce hypercontractive muscle disorders. Since the prostate gland as well as the bladder are influenced by autonomic innervation, theoretically, administration of BoNT-A into the prostate gland will cause denervation and modulation of prostate function, thereby reducing SDS. Additionally, BoNT-A has been shown to induce prostate apoptosis, regulate alpha-1A receptors, and reduce prostate contractile function in animal studies. . A systematic review and meta-analysis evaluating BoNT-A injection for the treatment of BPH found no differences in efficacy or procedure-related adverse events compared with placebo. There is insufficient evidence of clinical benefit and therefore no clear recommendations for its use can be made.
Conclusion
Minimally invasive treatment of benign prostatic hyperplasia is an area of intensive development and clinical application of new methods that have proven their effectiveness. Most of these techniques involve a short hospital stay, and some can be performed on an outpatient basis. Complications reported have a low frequency and a low Clavien-Dindo intraoperative complication score.
Prostate injections have not lived up to expectations and their use is not recommended.
Histotripsy, as a non-invasive method, needs to be further evaluated in clinical trials with larger groups of people.
The results of the initial prospective experience with TIND treatment for PSD due to BPH are promising but require further validation.
The AQUABEAM system has favorable results, but results comparing it with TURP have not yet been presented.
The UroLift System procedure demonstrates consistently good functional results similar to TURP for up to 3 years, with the benefit of improved PSD while maintaining erectile and ejaculatory function (unlike TURP).
Convective water ablation (Rezum System) is promising in terms of functional symptomatic improvement of symptoms of benign prostatic hyperplasia, while maintaining erectile and ejaculatory function (unlike TURP), and minimizing the risks of retrograde ejaculation (ejaculation).
Important! The basis of a correctly chosen treatment method for benign prostatic hyperplasia is timely examination and correct diagnosis. The accuracy of the diagnosis depends on the qualifications of the doctor. The result of the operation is determined by the doctor’s experience and level of competence.