The TUNA Procedure for BPH: Basic Procedure and Clinical Results
http://www.medscape.com/viewarticle/416646?src=search from Infections in Urology ® Muta M. Issa, MD, Samuel E. Myrick, MD, Nikolas P. Symbas, MD
Abstract and Introduction
Abstract With transurethral needle ablation (TUNA), the inner region of the prostate is selectively ablated while the prostatic urothelium is preserved. This minimizes postoperative morbidity while maintaining impressive subjective improvement (satisfied asymptomatic patients). The new TUNA instrumentation has simplified the procedure and is expected to positively impact the procedure performance. The vigorous research and development in the field of prostate thermal therapy is responsible for the fast turnover in instrumentation designs to enhance performance. This is reflected in variations of results reported over a relatively short period of time. Introduction Various forms of minimally invasive thermal therapies have emerged, which include transurethral needle ablation (TUNA) of the prostate,[1-14] transurethral microwave thermotherapy (TUMT),  interstitial laser thermal therapy (ILTT), and high-intensity focus ultrasound (HIFU) thermal therapy.  The TUNA procedure has recently undergone extensive evaluation. It utilizes radio-fre-quency energy for thermal ablation. This second installment of a 2-part series describes the basics of the TUNA procedure and presents an update of the clinical results as they apply to the treatment of benign prostatic hyperplasia (BPH).
The TUNA Procedure
The TUNA procedure is performed with the patient in the lithotomy position, using 2% local lidocaine anesthesia per the urethra. The local anesthesia is supplemented with intravenous sedation when necessary; however, we recently began using transperineal prostatic blocks to achieve total local anesthesia without the need for supplemental sedation. This technique allows the procedure to be performed in an outpatient clinic setting without the need for conscious sedation monitoring. The appropriate length of the needles to be deployed and the number of planes to be treated are calculated based on the sonographic transverse diameter measurement of the prostate and the cystoscopic prostatic urethral length, respectively. The length of needle deployed (L) in millimeters is calculated using the formula L equals 1/2 TD minus 6, where TD equals transverse diameter of the prostate on ultrasound in millimeters. This calculation ensures that the tip of the needle stays within the prostate, approximately 6mm from the prostatic capsule. The shields are deployed for 5mm to 6mm to cover the base of the needles adjacent to the TUNA catheter. The number of treatment planes are calculated based on the length of the prostatic urethra. We recommend 1 treatment plane for every 1cm to 1.5cm of prostatic urethra length, with a minimum of 2 planes, irrespective of the urethral length. The planes are equidistant from each other in each lobe. The TUNA catheter is inserted transurethrally into the prostatic urethra, and its tip is positioned at the desired treatment plane. The needles and shields are then deployed and advanced into the prostatic lobe to their appropriate lengths. A 4-minute "rise time," a 1- to 2-minute "hold time," and a target peripheral rim temperature of 50°C to 55°C (122°F-131°F) are chosen. The radio frequency is delivered by the generator in an automated fashion to ensure a steady temperature rise of 3°C to 4°C (37.4°F-39.2°F)/minute at the peripheral rim of the ablation region in the prostate. Temperature is measured via a thermosensor located at the tip of the shields. There is a tendency for the urethral temperature to rise about 40°C to 43°C (104°F109.4°F) during the treatment session due to heat conduction from the nearby ablation lesion; however, temperature may be quickly restored to baseline with the use of irrigation fluid. The same procedure is repeated at different planes in the prostate according to the initial calculation.
Anesthesia Requirement During TUNA
There continues to be a wide variation in anesthesia used for TUNA among urologists and institutions. This variation may be explained by the variability in urologist preference, the patient pain threshold, and the rules and traditions of various medical institutions. Indeed, it is reasonable to use spinal or general anesthesia for the first few TUNA cases. This facilitates the initial learning process and ensures one less thing about which to worry. With a more experienced urologist, most patients (>90%) can undergo the TUNA treatment under local anesthesia. Local anesthesia includes the topical instillation of lidocaine gel in the urethra combined with regional infiltration of lidocaine/marcaine into the prostate and paraprostatic tissue through various anatomical approaches, such as transperineal, retropubic, or transurethral prostatic blocks. Furthermore, supplemental oral or parenteral sedation/narcotics may be used. At our institution, we favor the transperineal prostatic
10.14] Prostate Size There is no convincing evidence that prostate size is significantly reduced following TUNA.8.14] A statistically significant decrease in the ultrasound size of the prostate has been reported. Its current utility has been surpassed by various other parameters.7. Exclusion of the series with the "least" and "most" improvement (to minimize bias) did not impact the results. 30%  and 33% compared with over 50%. mostly anecdotal on our part. poor patient selection.
The first series of 12 TUNA procedures in the US was performed in 1994.12. and 92% at 3 years. there is an impressive and complete resolution of the irritative voiding symptoms within the first few days. Europe. Intraoperator variability is common and has to be taken into consideration so as not to over-credit volume changes measured by ultrasound.8-14] The overall average improvement is 58% at 1 year (546 patients in 10 series). Therefore.11. Australia. These results were statistically significant when compared with baseline and surpass the expected placebo range of 30%.7-9. making it possible to perform the procedure in the outpatient clinic without elaborate and extensive set-up. Possible explanations for this slow recovery include very small prostates. In the US randomized trial comparing TUNA with TURP.14] Conversely.7. the Food and Drug Administration approved TUNA in the US in October 1996. The procedure was also approved in Africa.[9. These reasons are observations. [2.  Based on the results of this study. There are. This obviates the need for conscious sedation monitoring. less emphasis is currently placed on PVR.[12. Subjective Improvement Significant subjective improvements in the symptom score have been reported in various series (Table I).without the use of supplemental sedation or narcotics -as the primary method. Occasionally.12-14] Nonetheless. With regard to the bother scores and quality-of-life scores. A major clinical trial in the US compared TUNA to TURP in a randomized.block with intraurethral instillation of lidocaine gel -. one has to interpret this finding carefully and question its clinical significance.  This result may simply reflect the low sensitivity and reliability of our current technique of transrectal prostate ultrasound in accurately measuring small changes in prostatic volume. improvements were similar and parallel to the improvements in symptom scores. respectively.  The improvement in the peak flow rate (Qmax) reported in the majority of the worldwide literature falls in the range of 60% to 80% (Table I). it significantly reduces the global cost of the TUNA procedure by omitting operating room and anesthesia charges. Asia. and treatment of enlarged median lobes. improvement is seen fairly early (within 2 weeks) and is usually complete within 6 weeks following TUNA treatment. 66% and 54%. 2 reports of significantly greater improvements of 121% and 280%.13] The interpretation and clinical value of PVR have traditionally been overrated. Furthermore.4. 82% at 2 years. extending to 3 months. (click image to zoom)Cystoscopic appearance of prostate 3 months after TUNA procedure: (A) during "static" phase and (B) during "dynamic" voiding phase.4. As with the results of the symptom score. and North and South America.
. these peak flow rate results are statistically significant when compared with baseline and surpass the expected placebo range of 30%.3. and many series have stopped reporting on this parameter. Conversely. as expected. there are other series with notably lower improvement. [1. and have not been studied specifically. Postvoid Residual Urine The decrease in the postvoid residual (PVR) urine volume ranged from 13% to 80%. Endoscopic Appearance of Prostatic Urethra
Figure 1. controlled way. a few patients experience delayed and slow recovery. thermal ablation bladder necks.[1. suboptimal surgical technique leading to urothelial thermal injury. however. [4.  Following this initial pilot study. A summary of the worldwide literature shows an overall average improvement in the peak flow rate (Qmax) to be 77% at 1 year (546 patients in 10 series). 60% at 2 years. and durability. efficacy. the latter 2 series reported significant improvement in the symptom score. the improvements in all subjective parameters were similar following both procedures. however.3. the procedure underwent vigorous testing through various clinical trials to determine safety.3. In general. and 66% at 3 years.
Erectile Dysfunction The incidence of erectile dysfunction is negligible (0-<2%) following the TUNA procedure in the majority of the world literature.5% of patients and are related to instrumentation of the urethra. Also.11. Morbidity is relatively insignificant. (B) Changes are more prominent in proximal region of left prostatic lobe. such as the prostate. fluoroquinolone antibiotics (500mg ciprofloxacin bid) given preoperatively and continued for 5 days postoperatively have been effective in preventing urinary infection and epididymitis.7. Patients with significant coagulopathy may experience more pronounced hematuria and should be counseled about this preoperatively. this rate improves with more experience.12.14] The 2 largest series indicated that maximum detrusor pressure decreases significantly after TUNA. Urinary manipulation of an infection-susceptible organ. such as aspirin and nonsteroidal antiinflammatory drugs. usually lasting 1 to 7 days and rarely more than 2 to 4 weeks.9. This raises important questions regarding the mechanism responsible for therapeutic improvement following TUNA.1%).13] The remaining 3 studies. (click image to zoom)Cystoscopic appearance of prostate 6 months following TUNA procedure.14] 1 of which had equivocal results.13. Antiplatelet agents. [9.  It is possible that more aggressive TUNA therapy to the region of the bladder neck is responsible for this. [1. [1-4.Figure 2. however.[1-9.3] In 1 series.[1. [1. 13% of TUNA patients noticed some change.13] The risk of postoperative infection is minimized by ensuring urine sterility preoperatively and by the use of antibiotics.14] In 1 series of 38 sexually active patients. suggested that obstruction persists despite the improvement in other subjective. is noted in most patients for a period of 24 hours.9. a puzzling 16%
. Urinary Retention The rate of postoperative urinary retention ranges from 13. In the US randomized clinical trial. which does not require specific treatment.13] The relatively small diameter of the TUNA catheter and the short duration of the treatment put the patient at lower risk for development of urethral stricture than after standard TURP. Ramon and colleagues  reported a surprising improvement in sexual function in 42% of patients after the TUNA procedure.5%) than following TURP (7. the rate of urethral stricture was significantly lower following TUNA (1. a marginal decrease in the amount of ejaculatory fluid has been suggested in limited cases (without objective proof). (A) Prostatic urothelium is markedly retracted at site of TUNA treatment in distal region (apex) of left prostatic lobe. parameters. Urinary Infection and Epididymitis Postoperative urinary infection and epididymitis occur rarely (0% to 3.13] The retention is transient (12-48 hours) in the majority of patients. These are mild and transient in nature.6%. in a setting of tissue necrosis requires full antibiotic coverage.3. Irritative Voiding Symptoms Dysuria and increased urinary frequency without urinary infection may develop in approximately 40% of patients during the initial postoperative period.9. Hematuria A mild degree of transient macroscopic hematuria. It is recommended that such coagulopathy be corrected before the surgery. as well as objective.3% to 41.  Retrograde Ejaculation No objective evidence currently exists in the literature that retrograde ejaculation occurs following TUNA.4.
To date. giving appearance of "tunneling. however. [1. [1-4. no mortality has been reported with the TUNA procedure.3%). During the initial learning phase.6. Urethral Strictures Urethral strictures occur in 0% to 1. urinary retention is in the 40% range. patients are advised to discontinue these for 7 to 10 days before TUNA if possible. However. In our experience." Pressure Flow Studies At least 5 studies addressed detrusor pressures before and after TUNA (Table II).12. usually pose no major problems.
(2) patients who have significant and bothersome voiding symptoms. Thermal neural ablation. has been demonstrated by various researchers. yet who are asymptomatic. Traditional thinking indicates that irritative symptoms are a result of obstruction and that they should. AUA Symptoms The symptom score used by the American Urological Association explores 7 symptoms. urgency. Yet the improvement in the voiding symptoms matches that of TURP. this report remains unique. and intermittency) and 3 are irritative (frequency. less bother is generally felt by patients as they watch their intermittent weak stream or take an extra minute to complete voiding once they reach the bathroom. yet whose prostates appear small and nonobstructing on cystoscopy. This theory is supported by the results of anatomical debulking procedures. Anatomic debulking is not significant. urologists have designed procedures to treat BPH -. By design. yet whose prostatic urethras appear nonobstructing on cystoscopy. and improvement in peak flow rates and maximum detrusor pressures is less pronounced than after anatomic debulking procedures such as TURP. Therefore. which alters the physiologic function of voiding (dynamic component of BPH). improve once the obstruction is treated. Zlotta and associates  reported a 79% (30/38) success rate in patients with urinary retention. therefore. laser prostatectomy. There is increasing evidence that the therapeutic effect of TUNA is explained by intraprostatic neuromodulation.19] Millard and others reported an 85% (17/20) initial success rate. the embarrassment of rushing to the bathroom (urgency).
TUNA in Patients With Urinary Retention
Few reports currently exist regarding the efficacy of TUNA in the treatment of urinary retention secondary to BPH. and (5) patients with cystoscopically obstructing prostate. The advent of thermal therapies has brought a new understanding of BPH symptoms. hesitancy. Patients may be satisfactorily treated in a minimally invasive way. An anatomic debulking procedure aims to unblock the prostatic urethra and is likely to improve the obstructive voiding symptoms. one must question the traditional thinking of anatomic debulking in BPH treatment and whether it is essential for the success of the treatment. including surgical alpha-receptor blockade. this thinking may be challenged in the following individuals: (1) patients who experience continued voiding symptoms following TURP. However. and nocturia). approximately 3 are obstructive (weak stream.[14. and inconsistent with the majority of the worldwide literature. Although it is difficult to categorize the various symptoms clearly into obstructive and irritative. (4) patients treated successfully with thermal therapies without decrease in size of their prostates. On the other hand. patients are distressed by their inability to do basic daily activities. which later decreased to 75% (15/20) when 2 patients underwent TURP for persistent voiding symptoms. Bother The amount of bother patients experience is influenced more by their irritative rather than obstructive symptoms. both obstructive and irritative. All of these symptoms are related to the irritative aspect of BPH. in the majority of patients (approximately 70% to 80%). (3) patients who are responding satisfactorily to treatments with alpha-adrenergic blockers without decrease in the size of their prostates. Nonetheless.18.
Mechanism of Action of TUNA
The insignificant changes in prostate size and the disproportionate improvement of subjective as compared with objective parameters raise important questions regarding the mechanism of TUNA action. or intraprostatic stents.a condition of obstructive and irritative symptoms -.that aim to treat obstruction even though irritative symptoms cause the majority of bother. without necessarily resulting in TURP-like flow rates and detrusor pressures. This allows the TUNA to be cost-effective by eliminating the fees
. such as driving. unexplainable. This issue is controversial and requires closer analysis of BPH symptoms. inability to sleep through the night (nocturia). Similarly. The remaining 1 (feeling of incomplete bladder emptying) falls between the 2 categories.
TUNA is performed as an outpatient clinic procedure under local anesthesia using topical intraurethral lidocaine gel and regional prostatic block. To date. Indeed. and occasional urge incontinence. For many years. this approach does not aim to treat the irritative voiding symptoms specifically.deterioration and 21% both deterioration and improvement in sexual function were reported in the same series. or watching a movie or game without interruption (frequency). improvement in the irritative voiding symptoms follows.
. TUNA holds promise for many patient populations. Symbas is a Resident in Urology at Emory University School of Medicine. Myrick is a Fellow in Urology at Emory University School of Medicine. which is significantly less than the current global cost for TURP. for preparing the illustrations. Katrina Anastasia. Ga. Department of Medical Media. Mass.
As with any new technology. combined research and development efforts will further improve efficacy and durability." [2. computer graphic designer. 1998. the TUNA system underwent improvement in optics. [2.] and $200. Also. Furthermore. In addition. the global fee is approximately $3500 to $4000 in the US. © 1998 Cliggott Publishing.000 for the Prostatron System from EDAP [Technomed. anesthesia team. With the current need for savings in our health care system. At the same time. Ga. Minn. Issa for her editorial assistance. Changes usually have a positive impact on outcome since they tend to be designed to correct problems of previous experience. generators.]). The excitement of dynamic progress is pitted against the sense of uncertainty regarding the final outcome of new therapies. For example. and Ms.23] The current initial set-up cost of the TUNA system (generator and computer) is approximately $40. and Ms. PA. The TUNA system is significantly less expensive than microwave thermal therapies (approximately $500. Dr. it is important to be aware of the changes in instrumentation and technique during clinical trials and how they affect the final outcome. Currently. Atlanta. and Chief of Urology. Atlanta.000 for the Targis System [Urologix. for their contribution to the minimally invasive BPH therapy program at The Atlanta Veterans Affairs Medical Center. MBA. further refinement in instrumentation and technique is expected. Lois Elayne Miller. computer software. These figures translate to approximately $1900 to $2400 in professional and facility fees. and technique continues to fuel various revisions and improvements in the field of minimally invasive therapies.
iInfect Urol 11(5):148-154. Atlanta Veterans Affairs Medical Center. This translates to approximately $500 to $800 per patient. The pressure to improve results by better instrumentation. Finally. Atlanta Veterans Affairs Medical Center. Minneapolis. to pay for this initial investment. The era of prolonged clinical trials of single. Jill T. Dr. but more importantly. particularly elderly individuals with high surgical risk. strict protocols is slowly disappearing for any new technology. Burlington.000 in the US. ground pad.associated with operating room. We also would like to thank Mr. In general. Issa is Assistant Professor of Urology. it is a good policy to review various reports and exclude those with the best and the worst results in order to minimize bias. recovery room. makes this treatment more attractive than TURP for many patients. the economic impact of TUNA is paramount: Cost has been reported to be significantly less (40%-70%) than that of TURP. Acknowledgements We would like to thank Ms. enthusiasm for new approaches must be tempered until convincing results become available. Division of SCP Communications
. cables) is approximately $700 to $800 per case in the US. and conscious sedation monitoring. minimally invasive treatment. the lack of significant risks. Ga.23] The ability to perform TUNA under local anesthesia further augments its role as a "minimally invasive therapy. Therefore. Denis Roy. and technique during the 3-year course of clinical trials (1994-1997). Cost savings benefit the patient as well as the health care industry in general. RN. one should not overlook a good technology on the basis of attitude rather than fact. Dr. The cost of the disposables (catheter. based on the first 50 to 80 patients. Emory University School of Medicine in Atlanta. As with all thermal therapies. urologists should resist pressures and question the wisdom of paying up to 10 times more for an alternative thermal therapy system. additional widespread experience is expected to enhance patient selection criteria for prediction and optimization of outcome.
The rapid pace of research and development in the field of thermal therapy of the prostate continues to be responsible for much of the potential variability in the clinical results. the patient benefits from a convenient. specifically those of incontinence and sexual dysfunction.