|Year : 2006 | Volume
| Issue : 3 | Page : 188-193
Minimally invasive treatments for benign prostatic hyperplasia
Brian A VanderBrink, Gopal H Badlani
Department of Urology, Long Island Jewish Medical Center, New Hyde Park, New York, USA
Gopal H Badlani
North Shore-Long Island Jewish Health System, Long Island Jewish Medical Center, 270-05 76th Avenue, New Hyde Park, NY 11040
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Minimally invasive treatment (MIT) options for relief of symptoms attributed to benign prostatic obstruction (BPO) are becoming a more commonly used option for patients failing medical therapy. These MIT utilize an endoscopic approach to either ablate the obstructing prostatic tissue by a variety of techniques or to place a urethral stent to relieve BPO. The uniting factor in all MIT is to decrease or eliminate the current morbidity and complications that accompany the standard surgical therapy such as transurethral resection of prostate (TURP). Clinical trials evaluating the efficacy and morbidity of these MIT modalities, either alone or in comparison to TURP are reviewed. Level I evidence (randomized controlled trials) are present for most of the MITs and provide the strongest support for overall conclusions. Symptomatic improvements and quality of life (QoL) improvements for all of the MIT follow a similar pattern with a more pronounced improvement in outcomes for the more ablative techniques. Uroflowmetry and durability of outcomes, however, seem to demonstrate little differences amongst the therapies. Disparities existed in the morbidity observed with the different techniques. Urinary retention and urinary infections were more common in the ablative technologies. Rates of blood loss, urinary incontinence, sexual dysfunction and urethral strictures were observed at a lower rate in the MIT groups when compared to the rates observed in TURP. The morbidity and durability of TURP is higher and longer than that of MIT, respectively.
Keywords: Benign prostatic hyperplasia, minimally invasive therapy
|How to cite this article:|
VanderBrink BA, Badlani GH. Minimally invasive treatments for benign prostatic hyperplasia. Indian J Urol 2006;22:188-93
| Introduction|| |
Benign prostatic hyperplasia (BPH) is a common histological finding in men with advancing age and the prevalence approaches nearly 90% in men in their eighties. While not all patients with BPH develop symptoms, there are a substantial number that do. BPH related outcomes (i.e., hematuria, urinary retention, infection) and lower urinary tract symptoms (LUTS) secondary to BPH can have a significant impact on patient's quality of life., Medical therapy is the first line therapy in moderately symptomatic patients, however refractory patients may require surgical intervention. Transurethral resection of the prostate (TURP) remains the gold standard for the treatment of benign prostatic obstruction (BPO), however the morbidity associated with the procedure has spurned investigators to develop alternative treatment options in patients with symptomatic BPO.,
Minimally invasive treatment (MIT) options utilize an endoscopic approach to either ablate the obstructing prostatic tissue by a variety of techniques or to place a urethral stent to relieve BPO. The uniting factor in all MIT is to decrease or eliminate the current morbidity and complications that accompany the standard TURP. Using MEDLINE search engine, the number of papers published on MIT has steadily increased within the last five years reflecting their increased usage as a treatment option for BPO. There are limited series describing the long-term results of MIT compared to the abundant papers on long-term efficacy of TURP, which has tempered enthusiasm in some clinicians to implement MIT in the treatment of BPO.
The MEDLINE and Cochrane library was searched to identify studies of 3 months or greater in duration and with at least 10 subjects in each treatment arm. The data was also extracted based on study design, subject and treatment characteristics, adverse events, urinary symptoms and urinary flow. This review will discuss relevant prior clinical papers describing MIT and their results.
| Transurethral Microwave Thermotherapy (TUMT)|| |
Microwave thermotherapy uses high temperatures to produce necrosis of obstructing prostatic tissues attempting to achieve similar results seen with TURP. Heat is transmitted into the prostate via transurethral route which destroys tissue by achieving temperatures that exceed the cytotoxic threshold of 45°C. During the last decade, several clinical studies have been published documenting the outcomes from the application of TUMT for the treatment of LUTS associated with BPO. The studies have used different devices and energy protocols, have had different follow-up periods and responses criteria and differed in patient selection. Many TUMT devices with different technical specifications and treatment protocols were evaluated.
Hoffman et al combined all evidence from randomized controlled trials evaluating the efficacy and safety of microwave thermotherapy in treating men with LUTS and BPO in order to quantify the therapeutic efficacy. Overall 540 patients were randomized including 322 to TUMT and 218 to TURP. ,,,,,,,,, All patients had moderate LUTS with decreased urinary flow and moderately enlarged prostates. Exclusion criteria were men with prostate volumes > 100 grams, prominent median lobes and those in urinary retention. Treatment was stratified by different TUMT devices and software including Prostatron (Prostatsoft 2.0 and 2.5) and ProstaLund Feedback. The mean pretreatment International Prostate Symptom Score (IPSS) score was 19.5 (range 15.7-21.3), maximum urinary flow rate (Qmax) 8.6 ml/sec (range 7.9-10.1) and prostatic volume 44.5 cc (range 33.9-52.7) and did not differ by treatment group. Two studies followed patients for 6 months while the remaining four provided 12-month follow-up. Eighty-five to one hundred percent of patients completed follow-up.
Five out of the six (83%) studies demonstrated significant decreases in IPSS along with significant increases in Qmax between baseline and follow-up for TUMT. TUMT was less effective than TURP in reducing LUTS as assessed with IPSS, with mean IPSS decreasing 65% in 12 months for men undergoing TUMT compared to 77% in men undergoing TURP. TURP also had a greater impact on Qmax relative to TUMT, 119% increase vs. 70%. Three studies evaluated the effect of treatment on quality of life (QoL) and although QoL significantly improved following TUMT and TURP, there were no significant differences between treatments.
While there is ample evidence about the short-term efficacy of TUMT, long term results are not as plentiful. Historically, the low energy TUMT has been abdandoned because of poor durability of its effect. At 5 years after TUMT with the Prostasoft 2.0, 41% of patients had received instrumental retreatment and 17% were being retreated with medication. Conversely, utilizing higher power TUMT software, studies demonstrate results at follow-up of 36 months of Qmax and IPSS of 11.9 ml/sec and 8, respectively., Retreatment rates with these higher power systems have reduced the rates to 19-29 %.,
The morbidity associated with TUMT with regards to catherization time, the incidence of dysuria/urgency and urinary retention were in favor of TURP. However, the incidence of hematuria, clot retention, transfusions, TUR syndrome, erectile dysfunction, retrograde ejaculation and urethral stricture are significantly less for TUMT than for TURP.
While the previous the discussion has focused on comparison of TURP and TUMT, Djavan and colleagues conducted a comparison of medical therapy with alpha-blockade and TUMT for moderately symptomatic BPH patients. In this randomized trial of 103 patients, the authors demonstrated that at 6 months follow-up the clinical outcomes of TUMT were significantly greater than those achieved with terazosin including IPSS, Qmax, QoL and treatment failure. An update at 18 months demonstrated the improvements in outcomes were significantly greater in the microwave group compared to terazosin group.
| Transurethral Needle Ablation|| |
Transurethral needle ablation (TUNA) therapy uses low-level radiofrequency energy that is delivered by needles placed transurethrally into the prostate that produces localized necrotic lesions in the hyperplastic tissue. The tissue is selectively ablated to temperatures approaching 90-100°C while the urothelium of the prostatic urethra is preserved. The advantage of TUNA is that it can be delivered under topical anesthesia to patients with symptomatic BPO and is an attempt to minimize operative risk while optimizing therapeutic benefit.
The initial clinical evaluation of TUNA was conducted in Europe in the early 1990's. Subsequently several clinical studies of TUNA have been reported with significant improvement in symptoms scores, however a minority of these were randomized studies. The number of patients followed long-term is also limited which can make it difficult to draw meaningful conclusions, however two recent publications provided a substantial part of the long term data of TUNA outcomes for the committee and are briefly discussed.
Hill and colleagues reported five-year outcomes in multicenter randomized clinical trial comparing TUNA and TURP. Following treatment significant improvement occurred in symptom score and it was higher in TURP than in TUNA [Hill]. The two groups demonstrated a significant improvement in Qmax which also was greater in TURP patients. TUNA did show a lesser incidence of adverse events when compared to TURP patients. Retrograde ejaculation was reported in 41% of TURP patients while the TUNA group reported none. Retreatment rates at the time of the report were 14 and 2% for the TUNA and TURP group, respectively. The results of these studies demonstrate stable treatment outcomes up to 5 years of follow-up and suggest that TUNA is an attractive treatment option for men with LUTS due to BPO.
Boyle and colleagues conducted a recent meta-analysis of clinical trials of TUNA. The meta-analysis showed that TUNA was an effective and minimally invasive treatment for men with clinical BPH, even with severe LUTS. There was a significant improvement in symptoms and flow rate after 1 year that persisted for at least 5 years. Although there was a tendency for the Qmax to decline slightly over time, the mean Qmax five years after treatment was still 50% improved over the baseline value. The most common complication reported after TUNA therapy is urinary retention, ranging from 13-41%. TUNA therapy would appear to be an alternative to surgery and an attractive option for men who do not wish to undergo long-term medical therapy, are poor candidates for surgery or are concerned about the side-effects of TURP.
| Prostate Injectables|| |
Transurethral ethanol ablation of the prostate (TEAP) is defined as minimally invasive transurethral procedure to effectively treat patients with BPO by injecting anhydrous ethanol into the periurethral prostatic tissue under continuous urethroscopic irrigation. Microscopically the ethanol injection created a uniformly demarcated line of tissue necrosis that did not extend to the capsule of the prostate or to the sphincter. After TEAP, IPSS and QoL score decreased significantly at 1 month and these improvement were sustained at 12 months however, Goya et al followed 17 patients for longer than 3 years (median follow-up 4.3 years) and reported durable improvements in only 59%.
A multi-institutional randomized study comparing two methods of alcohol injection (TEAP) to TURP in men with symptomatic BPH was reported by Badlani et al . Sixty men with significant LUTS were participated in a three-arm randomized study to compare the effects of superficial injection (0.5 cm) of ethanol, deep injection (1.0 - 2.0 cm) of ethanol or TURP. The dose for ethanol injection (superficial and deep) was determined by prostate size and urethral length. Study results reported approximately 60% reduction in IPSS at the one-month evaluation among TEAP deep injection subjects, which were sustained to the 12-month visit. Superficial injection provided varying results, showing 55% reduction in IPSS. TURP results produced 54% and reduction in IPSS at one-month and reported greater than 65% improvements at the 12-month visit. At the 12-month evaluation, TEAP subjects maintained 30% voiding improvements in Qmax, whereas TURP subjects reported more than 97% improvement.
The most common reported adverse events with TEAP were storage symptoms (21%), urinary retention (17%) and hematuria (13%), most of which resolved without intervention by one month post TEAP. Bladder necrosis was reported in three cases including one case where urinary diversion was necessary. The local toxicity in the form of spreading necrosis associated with TEAP warrants further research in establishing the safe injection site before it could be recommended and should be remain investigational.
| Prostatic Stents|| |
Urinary drainage catheters function on the premise of passive bladder drainage whereas urethral stents work on the principle of active drainage, requiring a detrusor contraction. Urethral stents have been used as a bridge before more permanent therapy in those patients who are not presently medically stable or at high surgical risk or after procedures where urinary retention can result temporarily as in microwave thermotherapy or brachytherapy.
The original justification for stents in treating BOO secondary to BPO was in men at high surgical risk. Early reports of the UroLume Wallstent (American Medical System, Minnetonka, MN) outlining success in men with severe LUTS and retention prompted the evaluation of their use in men who were otherwise healthy and good operative risks. These multicenter trials included the North American UroLume Study group and European Multicenter Study., Two-year follow-up in these studies revealed significant and durable changes in the following: decreases in IPSS, post-void residual volume and increases in Qmax in men with and without urinary retention. Voiding symptoms were alleviated best, whereas men with storage symptoms had the most difficulty tolerating the stents. Stent removal was performed in 13 and 15% at two years in both trials, mainly due to detrusor overactivity, stent encrustation, stent migration, recurrent BOO, perineal pain and urinary incontinence. The memotherm stent (Bard, Covington GA, USA) is another permanent stent that is thermosensitive, biocompatible and flexible. 123 patients deemed poor operative candidates but necessitating TURP received the stent. Longest follow-up was 4 years but in only 4 of the 123 patients and mean follow-up was 12 months thus limiting the generalizations that could be made. The authors observed that their complication rate and retreatment rate exceeded that experienced at equal time points from early UroLume data where voiding symptoms were transient and obstruction was absent or mild. Kaplan and colleagues reported on the use of the TITAN Intra-prostatic Stent (Boston Scientific, Watertown, MA, USA) with significant improvements in symptom scores and Qmax after mean follow-up of 17 months.
Prostatic stents are a suitable alternative for patients who are at too high a risk for TURP as the stent can be placed under local or regional anesthesia, yet its use should be avoided in healthy men who can tolerate a TURP or an ablative MIT. The pool of patients who are ideal candidates for prostatic stents will likely decrease given the rise in popularity of heat therapies for BPO in men who are high surgical risks. Based upon the available data, long-term data for safety and efficacy for permanent prostatic stents exists but their clinical use is limited.
| Laser Prostatectomy|| |
Laser prostatectomy has become increasingly widespread form of MIT to treat BPO. It was originally described in 1986 but the advent of the side-firing laser is most likely the reason for its newfound popularity. Four types of laser have been used for the treatment of LUTS secondary to BPO; Neodymium: Yttrium Aluminum Garnet (Nd: YAG), the Holium: YAG (Ho: YAG), the potassium titaynl phosphate (KTP) and the diode laser. The laser techniques evaluated included coagulation, vaporization, resection and dissection.
Cowles et al randomized 115 patients to TURP or visual laser ablation of the prostate (VLAP) and found that the operative and hospitalization times were shorter in the VLAP group. The improvement in symptom score was 48 and 64% in the VLAP and TURP arm, respectively. The Qmax increased by 59 and 73% in the VLAP and TURP group, respectively. The long-term results were reported to durable. Urinary retention was observed in up to 30% of patients requiring catherization for up to several weeks. Sexual dysfunction was reported by up to a third of VLAP treated patients. Contact Nd:YAG laser vaporization was compared to TURP in a randomized trial by Keoghane and colleagues. Symptom score and Qmax improvement were quite comparable between the groups at both initial 3 month evaluation and at 7 years., The authors found that the voiding outcomes and reoperation rates were similar between the TURP and contact prostatectomy.
Interstitial laser coagulation of the prostate (ILC) uses a Nd:YAG, diode or holium laser fiber placed transurethrally into the prostate. Energy is applied, heating the adenomatous tissue resulting in necrosis. The aim of this technique is to preserve the urethra, thus preventing tissue sloughing with less storage symptoms than that seen with other laser techniques. A multicenter randomized trial compared TURP with ILC was published by Kursh et al . At 2 year follow-up, the Qmax improved by 81 and 51% in the TURP and ILC group, respectively. IPSS improvements were observed in 70 and 63% in the TURP and ILC group, respectively. The ILC group had significantly shorter hospital stay and better sexual function score. Floratos et al reported on long-term outcomes (34-53 months) after VLAP (n=107), contact laser (n=30) and ILC (n=53). Retreatment rate was highest in the ILC group compared to other groups (41 vs. 14%).
The KTP laser takes advantage of the efficiency of the laser in vaporizing tissue due to selective absorption of photons by hemoglobin and the consequent release of superficially trapped vaporizing thermal energy. Based on these qualities its name, photoselective vaporization of the prostate (PVP), was coined. Short-term studies showed safety and efficacy in the outpatient setting and at 24 hours the Qmax improved from 8-19 ml/sec and none of the ten patients developed dysuria, hematuria or required recatherization. A recent publication by these same investigators showed persistent significant improvements in IPSS, Qmax, QoL and post void residual urine volumes after 1, 2, 3 and 5 years. However data from only 14/24 patients who were 5 years out from their KTP laser prostatectomy comprised the 5-year data. PVP has been applied to certain subsets of men with BPH such as those with large volume prostates and increased risk of bleeding., Sandhu et al applied KTP laser in men with a mean prostatic volume was 101 cc and reported significant improvements in IPSS, Qmax and post void residual urine volumes at 12 months follow-up. As stated previously, the KTP laser has characteristics that allow unimpeded transmission through aqueous media to its chromophore, hemoglobin. This property makes PVP a highly hemostatic modality. Sandhu and colleagues retrospectively reviewed their experience in 24 men who were and were treated with PVP for symptomatic BPH. Of these men, 8 were on warfarin, 2 on clopidogrel and 14 on aspirin. Men on warfarin discontinued the drug 2 days prior to surgery and restarted it the day after. The other two drugs were not discontinued. The mean operative time was 101 minutes and no transfusions were required. The serum hematocrit did not change significantly and significant improvements in the IPSS and Qmax were noted. The main disadvantage of PVP is the lack of prostatic tissue available for pathologic analysis. The resurgence of vaporization techniques need to be better studied with long-term randomized trials of large number of patients prior to promoting it as having equivalent efficacy as TURP.
The Holium:YAG laser is a multifunction surgical laser that has multiple applications in the field of urology i.e., incision of urothelial strictures, lithotripsy, ablation of superficial urothelial tumors. The excellent hemostatic property of the holium laser results in a mostly bloodless field and decrease or eliminates the need for bladder irrigation. Holium laser ablation of the prostate (HoLAP) is a simple procedure and suitable for small to moderate sized prostates but is not efficient and is tedious for treating larger prostate glands. Like the KTP laser it also generates no tissue specimen for histopathological analysis. Tan et al reported a 7-year follow-up of 34 patients who underwent HoLAP. There was an 83% improvement in Qmax and 43% decrease in IPSS with reoperation rate of 15% and recatherization in 9% of patients. HoLAP is an easy technique with a short learning curve but the procedure is rather slow.
The holium laser resection of the prostate (HoLRP) is achieved using the end firing Ho:YAG laser fiber and is similar to the standard TURP. The prostatic lobe is incised and peeled off the surgical capsule. The lobe is then cut into small pieces to facilitate their removal with a modified resectoscope or Ellik evacuator. Westenberg et al published their results of HoLRP versus TURP in patients with BPO. Of 120 patients 73 completed the 48-month assessment. HoLRP and TURP resulted in significant improvements in all parameters. There was no difference between the 2 techniques in terms of urodynamic parameters, potency, continence and symptom scores at the 48-month assessment. HoLRP took significantly longer to perform but perioperative morbidity, catheter time, nursing contact time and hospital stay were significantly less for HoLRP compared to TURP. The two major critiques of the HoLRP procedure are the longer operative time than TURP (mean 16 minutes) and the resulting difficulties with pathological interpretation of the resected small pieces of adenoma that may be affected by thermal damage.
Holium laser enucleation of the prostate (HoLEP) is the most recent step in the evolution of holium laser prostatectomy. Randomized comparitive trials (level 1 evidence) have shown similar results for HoLEP and traditional surgery used to treat BPO. Tan et al randomized 61 patients to either HoLEP or TURP and found that HoLEP was superior to TURP for relieving BOO in terms of reducing maximum detrusor pressure at maximal flow. HoLEP and TURP led to significant improvements in peak flow rates, symptom scores and quality of life scores compared with baseline and there was no significant difference between the 2 procedures with respect to these parameters at 12 months. Fewer adverse events were reported in the HoLEP group compared to the TURP group. The morbidity of HoLEP was described by Kuo et al in 206 patients undergoing HoLEP. The transfusion rate was 1%, capsular perforation observed in 1.5% and bladder mucosal injuries in 1.9%. The recatheterization rate was 7.8%, bladder neck contracture and urethral stricture occurred in 3.9 and 2.4%, respectively. The substantial improvements in objective and subjective parameters used to measure LUTS secondary to BPO combined with the significantly reduced incidence of adverse events, has HoLEP being promoted as the new gold standard for the treatment of BPO.
| Conclusions|| |
Level I evidence (randomized controlled trials) are present for most of the MITs and provide the strongest support for overall conclusions. Symptomatic improvements and QoL improvements for all of the MIT follow a similar pattern with a more pronounced improvement in outcomes for the more ablative techniques. Uroflowmetry and durability of outcomes, however, seem to demonstrate little differences amongst the therapies. Disparities existed in the morbidity observed with the different techniques. Urinary retention and urinary infections were more common in the ablative technologies. Rates of blood loss, urinary incontinence, sexual dysfunction and urethral strictures were observed at a lower rate in the MIT groups when compared to the rates observed in TURP. The morbidity and durability of TURP is higher and longer than that of MIT, respectively. Surgical therapy for the symptomatic patient with BPO should be selected on an evidence-based approach and the urologist should maintain a healthy skepticism of newer MIT lacking long-term results to avoid falling for the "flash-in-the-pan."
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