Ceju 69 00859
Ceju 69 00859
Ceju 69 00859
Citation: Torz C, Poletajew S, Radziszewski P. A prospective, randomized trial comparing the use of KTP (GreenLight) laser versus electroresection-supplemented
laser in the treatment of benign prostatic hyperplasia, Cent European J Urol. 2016; 69: 391-395.
Article history Introduction Photoselective laser vaporization of the prostate (PVP) is one of the most popular techniques
Submitted: May 23, 2016 of treatment of benign prostatic hyperplasia (BPH). The aim of this study was to assess the risk of thermal
Accepted: Oct. 22, 2016
damage to the external urethral sphincter during PVP at distal part of prostatic urethra.
Published online: Nov. 30,
2016 Material and methods 66 men submitted to PVP with 80-W Green Light Laser were randomly assigned
to receive standard PVP only (group A) or PVP in proximal part followed by transurethral resection in distal
part of prostatic urethra (group B). Primary end-points of the study assessed at baseline, 24 hours and
8 weeks after the surgery were: urinary continence, urinary flow (Qmax), post void urine retention (PVR),
international prostate symptom score (IPSS), quality of life (QoL).
Results Per protocol analysis was eventually performed in 60 patients. Study groups did not differ in age,
Corresponding author
Sawomir Poletajew preoperative continence, values of Qmax, PVR, IPSS, QoL, or the rate of complete urinary retention
Medical University (p >0.05). During the 8-week follow-up no patient reported urinary incontinence, while decrease in IPSS
of Warsaw (16.3 vs. 14.9, p >0.05), QoL improvement (4.7 vs. 4.7, p >0.05), increase in Qmax (18.2 vs. 17.4, p >0.05)
Department of Urology were similar in both study groups. Patients assigned to group B were more likely to have bleeding compli-
4, Lindleya Street cations (85.2% vs. 18.2%), including patients requiring transfusion (14.8% vs. 0%). Moreover, postopera-
02005 Warsaw, Poland
phone: +48 22 502 17 02
tive catheterization time was shorter in group A (29.1 hrs vs. 37.2 hrs, p = 0.04).
slawomir.poletajew@wum. Conclusions Laser vaporization for treatment of BPH is safe and effective, with no significant effect on the
edu.pl risk of urinary incontinence in comparison to traditional methods.
applied primarily in ablation, enucleation and re- of 4080 ml measured by transabdominal ultra-
section of prostatic tissue (including the breakdown sound, the presence of enlarged prostate adenoma at
of deposits in the urinary tract) and Green Laser the level of verumontanum confirmed at urethros-
potassium-titanyl-phosphate (KTP) serving exclu- copy directly before PVP. Exclusion criteria were
sively the vaporization of prostate adenoma. as follows: active urinary tract infection, suspicion
The treatment of BPH using the 80-W potassium- of prostate cancer, urethral stricture, previous ure-
titanyl-phosphate laser (KTP) was first reported thral surgery, neurological disorders, lack of in-
in 1997 [2]. The first procedure in Poland was car- formed consent to participate in the study. Local re-
ried out in 2013 by professor Jeromin in d [3]. view board approved study protocol.
In comparison to previous technology (Nd:YAG la- Among 98 initially screened men, inclusion criterion
ser), the wavelength of the KTP laser (532 nm) has of enlarged prostate adenoma at the level of veru-
been halved, placing it in the green electromagnetic montanum was not met in 32 patients; hence they
spectrum (Greenlight-laser). The result is a com- were excluded from the study. Eventually 66 consec-
pletely different optical and energetic interaction utive patients were assigned into two study groups,
in contrast to other laser types [4]. Combing the based on consecutive patient numbers. Patients
high average power of a quasi-continuous wave laser with even and odd numbers were assigned to the
(80 W) with the high peak power delivery within study group A and the study group B, respectively.
each micro-pulse (up to 280 W) offers efficient vapor- In the group A, patients underwent vaporization
ization of prostate tissue. The short duration of each prostatectomy, seemingly incomplete, with the ter-
laser beam pulse (0.25 s) limits the thermal effect mination of the procedure at the level of the veru-
on deeper-lying tissue. KTP laser energy is selec- montanum. The remaining fragments of the lat-
tively absorbed by hemoglobin (and not by water), eral lobes extending in various degrees beyond the
which, at this wavelength, has a very high absorp- seminal colliculus/veromontanum were left intact.
tion coefficient and therefore penetrates prostate tis- In the group B, the vaporization procedure was also
sue to a maximal depth of 0.7 mm. This leads to im- discontinued at the level of the verumontanum,
mediate vaporization of prostatic tissue [4, 5, 6, 7]. however, the remaining fragments of the lateral
Though the laser energy penetrates to a tissue depth lobes of the adenoma were resected by means of the
of only 0.8 mm, the thermal effect spreads within standard TURP method (of course after changing
a 510 mm radius from the point of vaporization. endoscopic equipment).
Thermal damage of the external sphincter is a dis- All procedures were performed by the same sur-
tinct risk, especially when the prostate adenoma geon, using a single 80-W Green Light Laser fiber
is considerably enlarged beyond the verumonta- (American Medical Systems), water-cooled, emitting
num, approaching the above-mentioned sphincter. a monochromatic light source, operating at a 532 nm
Numerous authors have suggested that the degree wavelength. The laser fibers were introduced using
and frequency of postoperative urinary incontinence a laser cytoscope (Storz).
is strongly dependent on the age of the patient, but All patients undergone full urological evaluation
also, and perhaps more significantly, on prostate size, before treatment, including transabdominal ultra-
forcing the operator to intervene in the proximity sound (TRUS) measurement of prostate volume per-
of the external sphincter muscle [8]. formed by the same radiologist, accounting for me-
The goal of this study was to assess the risk of ther- dian (III) prostate lobe and retention, determination
mal damage to the external sphincter of the urethra of prostate-specific antigen (PSA), measurement
in men undergoing GreenLight laser vaporization of maximum flow rate Qmax (except in patients with
of BPH. complete urinary retention) and digital rectal exami-
nation (DRE). All patients were also asked to com-
MATERIAL AND METHODS plete the IPSS and QL questionnaire, and gave their
informed consent to participate in the study.
98 consecutive men with lower urinary tract symp- Patients were followed-up for 8 weeks postopera-
toms due to BPH were qualified for photoselective tively. Primary end-points of the study were change
KTP laser vaporization of the prostate (PVP). Mean in continence status, urinary flow (Qmax), post void
age of the cohort was 68.3 years. All patients gave urine retention (PVR), international prostate symp-
written consent to participate in the study. tom score (IPSS), including 7-scale (0-delighted,
Inclusion criteria were as follows: clinical symptoms 6-terrible) quality of life assessment (QoL). Second-
of BOO progressing or refractory to conservative ary study end-points were surgery time, bleeding
treatment, international prostate symptom score rate, catheterization time, storage symptoms in post-
(IPSS) of >10 or urinary retention, prostate volume operative course and surgical complications.
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Central European Journal of Urology
The data, obtained during the course of the study, vised scale: 0 represented no bleeding, 1 bleeding
were analyzed using Statistica 10.0. Normal distri- requiring coagulation during the procedure (with-
bution of all quantitative variables was confirmed out the need for blood transfusion, with no drop
with the use of the Shapiro-Wilk test, while homo- in hemoglobin), 2 persistent bleeding despite coag-
geneity of variance was tested according to Levenes ulation postoperatively (without the need for blood
formula. The students t-test was used to compare transfusion, but with a 12 unit drop in hemoglo-
the results between the groups, when achieving bin) and 3 bleeding requiring either plasma extract
a positive outcome of both afore-mentioned tests. or re-coagulation and blood transfusion (where the
In case of a negative outcome, U-Mann-Whitney drop in the hemoglobin exceeds 2 units). The evalua-
test was considered. The Chi-square test was imple- tion is presented in Table 2. In group A, no bleeding
mented for nonparametric variables. Statistical sig- (0 on the bleeding scale) was clearly encountered
nificance was defined as p <0.05. more frequently, whereas group B was evidently
more frequently characterized by persistent bleed-
RESULTS ing despite coagulation attempts, but without the
need for further intervention (p = 0.00).
Per protocol analysis was eventually performed After surgery, an 18 Ch Foley catheter was inserted
in 60 patients, including 32 and 28 patients in group and left for 24 hours. In 4 patients from group B,
A and B, respectively. From the group of 66 random- a three-way Dufour 20 Ch catheter was left due
ized men 5 patients were lost in follow-up (1 patient to bleeding. One of these patients required ex-
from group A and 4 patients from group B) and one traction for a few hours. The average holding
patient from group B died from cardiac insufficien- time, of the catheter after surgery, in group A was
cy not related to urological procedure. The general
characteristics of patients in study groups are pre-
sented in Table 1. Urinary tract infection was ex- Table 1. General characteristics of patients in groups A and B
cluded in all patients before inclusion into the study.
Group A Group B P value
Mean PSA was 2.47 ng/ml and 2.68 ng/ml in group
Number of patients 32 28
A and B, respectively. In the single case of elevated
PSA (25 ng/ml), two series of TRUS-guided pros- Age 67.2 8.4 years 69.5 9.0 years 0.29
tate biopsies were performed to rule out prostate Rate of patients with
21.9% (n = 7) 35.7% (n = 10) 0.24
cancer. Prior to the procedure, attention was paid complete urinary retention
to the presence of an median (III) lobe protruding Prostate volume 53.7 8.3 ml 52.3 8.7 ml 0.55
into the bladder, posing further difficulties in per- PSA 2.51 4.3 ng/ml 2.65 1.8 ng/ml 0.87
forming vaporization and thus prolonging the op- IPSS 22.3 3.5 20.8 2.9 0.16
eration time. This was observed in a total of 18 pa- IPSS quality of life score 5.1 0.8 5.2 0.7 0.55
tients (29%) across both groups. Statistical analysis
Qmax 6.7 4.1 ml/sec 5.0 4.0 ml/sec 0.14
failed to yield significant differences between the
two groups of patients. Presence of third lobe (n = 12) (n = 6) 0.17
During the 8-week follow-up no patient reported PSA prostate specific antigen; IPSS international prostate symptom score; QoL
quality of life; Qmax maximal urinary flow rate
urinary incontinence. Results in primary end-points
of the study are presented in Table 2. In postop-
erative studies of both 24 hours and 68 weeks af- Table 2. Postoperative results
ter treatment, there was a significant symptomatic
Postoperative
decline in accordance to the questionnaire results, correction
Group A Group B p p
and a significant increase in urinary flow. A B
Surgery time was 80.3 min (60120) in group A
IPSS 6-8 weeks
and 101.3 min (85150) in group B. The difference postop.
6.0 3.4 5.9 2.6 0.73 -16.3 -14.9 0.58
in operation times was observable both clinically
IPSS quality of
and statistically (p = 0.00), attributable to the nec- life score 68 0.4 0.9 0.5 0.6 0.42 -4.7 -4.7 0.89
essary variation of technique in group B (apparatus weeks postop.
and irrigation fluid change). The majority of the Q max 24h 15.4 4.1 14.0 3.7
0.25 230% 280% 0.26
procedures were carried out under spinal anesthe- postop. ml/sec ml/sec
sia. Only a few patients required general anesthesia, Q max 6-8 weeks 24.9 10.3 22.4 6.8
0.29 370% 450% 0.99
as a result of the presence of concurrent illness. postop. ml/sec ml/sec
Assessment of bleeding during the procedure was IPSS international prostate symptom score; QoL quality of life; Qmax maximal
carried out by the operator, according to a self-de- urinary flow rate
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Central European Journal of Urology
Table 3. Assessment of bleeding in operated patients to be much deeper than visible during endoscopy,
what makes injury to the urethral external sphinc-
Number
Bleeding
0 1 2 3 of bleeding ter possible [6, 7].
Scale
patients The early results of prostate vaporization in our
Group A 27 6 0 0 6 group of patients are very promising. Vaporiza-
Group B 4 7 12 4 23 tion of prostatic adenoma is characterized foremost
by its efficacy and safety. The main problem consid-
ered by our study, urinary incontinence, following
significantly shorter in comparison to group B (29.1 80W KTP laser vaporization of the prostate, was
hours vs. 37.2 hours, p = 0.04). not observed in any patient. Overall, 100% patients
All patients in group A had their catheters removed were found to be continent postoperatively, regard-
24 hours after treatment. However, 4 men required less of the methodology used. We are aware that
reinsertion of a catheter for another 24 hours due our patients were selected on the basis of prostate
to urine retention. Two patients, although urinat- volume, though all satisfied the criteria of our trial
ing independently, required catheter reinsertion due prostate adenoma reaching or slightly exceeding
to significant urine retention. A catheter was main- the level of the verumontanum. Some authors high-
tained maximally for 72 hours. light the fact that a significantly enlarged prostate,
2 patients from group B required re-coagulation due along with the patients advanced age, are predis-
to bleeding within the first 24 hours after surgery. posing factors for developing postoperative compli-
16 patients had a catheter maintained for a longer cations, such as urinary incontinence [8], associat-
period: due to bleeding 9 patients, repeated/signifi- ed with the thermal margins accompanying laser
cant urine retention 7 patients. vaporization.
All patients who underwent surgery, had urinary In group B patients, the significantly prolonged op-
flow and retention tests performed before leaving eration time is attributable to the necessary endo-
the hospital. All patients were asked to return to the scopic apparatus and irrigation fluid change. Fol-
clinic 68 weeks after surgery. Maximal urinary flow lowing classic TURP, even partial, problems with
and retention tests were performed once again, and hemostasis are more frequently observed. The aver-
patients were asked to complete an IPSS and QL age holding time of the catheter after surgery in this
questionnaire. Table 3 depicts these results. group was consequently longer. The supplementary
The major patient complaints encountered at follow- electroresection had no impact on either urinary
up (in some even earlier voluntarily) were sudden flow (though worse 24 hours postoperatively than
urge to urinate, groin and urethral pain. 12 patients in group A, these may be due to greater tissue swell-
from group A (36%) and 9 (31%) from group B report- ing) or IPSS and QoL parameters.
ed the above-mentioned complaints. Urine cultures Approximately 30% of patients had various types
were negative for infection. Patients were prescribed of complaints after surgery urgency, groin and ure-
alpha-blockers with or without anti-inflammatory thral pain. Nearly all authors of similar publications
medication, as well as cholinolytics. The medications refer to such transient symptoms in their patients.
were discontinued after approximately 6 weeks. These are most likely associated with tissue reac-
4 patients (6.5%) (both groups under further obser- tions after laser light exposure and a significant de-
vation) were re-admitted to the ward due to urinary gree of neurological receptor irritation [9, 10].
bladder neck and/or urethra narrowing. One patient Late complications occurred in 5 patients (8%), re-
(from group A) was reoperated after 14 months, per- sulting in further surgical intervention. Similar re-
forming TURP. None of the patients, from either sults were presented in patients after classic surgery
of the groups, complained of problems with uri- TURP [1, 9]. In other trials, this percentage was
nary incontinence. The frequency of reporting any slightly higher, reaching even 14%, but it should
of these symptoms did not differ between groups be noted that we are well aware of the number and
(p> 0.05). specificity of our patients [10].
DISCUSSION CONCLUSIONS
We performed a prospective randomized trial as- Where the prostate lobes of a large BPH extend be-
sessing the risk of functional complications related yond the verumontanum, the procedure may be in-
to PVP in the region of urethral external sphincter. terrupted at the level of the verumontanum without
This issue was never addressed before, despite clini- compromising urodynamic parameters or patients
cal relevance. The depth of tissue injury is proven well being. Additional resection of the lateral lobes
395
Central European Journal of Urology
of the prostatic hyperplasia using traditional meth- vaporization for treatment of BPH is safe and effec-
ods is only associated with an elevated risk of bleed- tive, with no significant effect on the risk of urinary
ing during and after the procedure, prolongation incontinence in comparison to traditional methods.
of operation time, increased urinary catheterization
times postoperatively, without affecting patients Conflicts of interest
urodynamic and IPPS and QL parameters. Laser The authors declare no conflicts of interest.
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