A prospective randomized comparative analysis of bipolar TURP and high-power Thulium vapoenucleation in the management of benign prostatic hyperplasia.

doi:10.21203/rs.3.rs-5309778/v1

Background:

Benign prostatic hyperplasia is on the rise as the life expectancy has been increased due to medical advancements. TURP once a gold standard is now slowly been replaced by lasers. As patients continue seeking less invasive and more efficient treatment options, they must be provided with evidence-based treatment options. Studies using 200-watt thulium lasers are scant and have a mixed population of small and large prostates. This study focuses mainly on large prostates(>60 cc) avoiding the biases in operating time and hospital stay and intends to to compare efficacy and outcomes of bipolar transurethral resection of the prostate (TURP) vs High power thulium vapoenucleation of the prostate (ThuVEP) in benign enlargement of the prostate.

Methods:

A total of 68 patients were included in our study of which 34 were randomly divided in 2 arms viz Bipolar TURP group V/s ThuVEP with a prostate size of more than 60 ccs..

An analytical between-group comparison was made of preoperative and perioperative data including operation time, intraoperative blood loss by measuring spothemoglobin on postoperative day 1, hospital stay, intra-operative and perioperative complications like capsular perforation, bleeding requiring transfusion, urinary tract infections, etc. Postoperative data was collected at 2 weeks, 6 weeks, and 3 months after surgery on IPSS, uroflowmetry with PVR, and residual prostate size at 3 months. Post-operative complications like SUI, urethral strictures, bladder neck stenosis, and the need for surgery for residual adenoma, were also compared.

Results:

ThuVEP was associated with statistically significant shorter resection time, lesser requirement of irrigation fluid in the postoperative period, less blood loss, & shorter hospital stay. IPSS, PVR, and voiding time were comparable between the 2 groups. The ThuVEP group had better Qmax and Qavg and residual prostate size at all times during follow-up. The two groups were similar in terms of complications.

Conclusion:

Both procedures could be performed with equal safety in larger prostates. However, ThuVEP outperformed Bipolar TURP in terms of blood loss, hospital stay , post-operative uroflow parameters, and residual prostate size.

BPH

ThuVEP

Bipolar TURP

Lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) are expected to place a growing burden on healthcare budgets, primarily due to their high prevalence among the elderly and the aging population¹. Bladder outlet obstruction (BOO) is detected in approximately 52% of asymptomatic and 60% of symptomatic men with BPH².

Monopolar transurethral resection of the prostate (TURP) has been the gold standard since the 1970s, significantly improving maximal flow rate (Qmax), urinary symptoms (measured by the international prostate symptom score, IPSS), and health-related quality of life³.

Despite the substantial symptom improvement achieved through TURP, it has several drawbacks, including fluid absorption leading to transurethral resection syndrome, fluid balance disturbances, blood loss, incontinence, and retrograde ejaculation⁴.

Multiple minimally invasive surgical techniques are being developed to match the outcomes of monopolar TURP but with fewer side effects. One significant advancement is the incorporation of bipolar technology. Bipolar TURP, including plasma kinetic bipolar resection of the prostate, which allows the procedure to be performed in physiological saline, enabling longer resection times and better hemostasis, thus permitting the resection of larger prostates safely^5.6.

Since the 2000s, new energy systems for surgical intervention in BPH, including bipolar energy and various laser systems such as holmium, potassium titanyl phosphate (KTP), thulium, and diode lasers, have gained popularity^7.8. The trend in surgical treatment for BPH has shifted from monopolar TURP to laser treatments and bipolar TURP⁹.

The KTP laser is selectively absorbed by hemoglobin and debulks prostate tissue through vapourization.¹⁰ For Photoselective vaporization of prostate, no tissue specimen is provided for histologic evaluation, and the speed of tissue ablation is significantly slower.

Holmium Laser Enucleation of the Prostate (HoLEP) is particularly noted for its effectiveness in endoscopically removing prostatic adenoma of any size and reducing complications, although it has a steep learning curve and longer operation times¹⁰.

The Thulium Yttrium Aluminum Garnet (Tm) laser, with a wavelength of 2013 nm, is easily absorbed by water, providing effective hemostasis and precise tissue resection with minimal thermal damage. This laser's continuous wave output ensures better vaporization and hemostasis, reducing the heat applied to tissues¹¹.

Literature comparing ThuVEP (high-performing system) and bipolar TURP, especially in larger prostates is scant. This research evaluates the safety and effectiveness of Thulium laser vapoenucleation (ThuVEP) compared to bipolar TURP for treating enlarged prostates (> 60 grams).

This randomized prospective study was conducted at a tertiary care hospital from November 2022 to April 2024 This study was approved by the Institutional Ethics Committee XXXX (Approval No: TP((DM/Mch/20/2022/IEC/XXXX/1096, Date: 12 November 2022).

The inclusion criteria were patients with prostate volume of more than 60 cc with either of the following: bothersome LUTS with failed drug therapy (Qmax < 15 mL/s), recurrent hematuria of prostatic origin, refractory urinary retention, recurrent urinary tract infections, bladder diverticula secondary to BOO, and obstructive uropathy secondary to BOO. Patients having a concomitant pathology like UB mass, bladder calculi, stricture, Ca prostate, patients with untreated coagulopathy, active urinary tract infection, and neurogenic bladder were excluded from the study.

Randomization was done using a sequentially numbered opaque sealed envelope (SNOSE) technique. Randomization and data collection forms: Subjects who meet the inclusion criteria were randomly divided into 2 arms viz Bipolar TURP group V/s ThuVEP. A proforma including various study parameters was used for data collection and follow-up.

Statistical analysis:

The analysis was conducted using IBM SPSS Statistics Version 25 for Windows software. Descriptive statistics were calculated, including percentages, means, and standard deviations. An unpaired t-test was used to compare two independent groups for quantitative data. For qualitative data, the chi-square test was employed to compare clinical indicators. A significance level of P ≤ 0.05 was established.

Study method and follow-up protocol:

All patients presenting with lower urinary tract symptoms (LUTS) were initially assessed through a comprehensive clinical history and physical examination, including a digital rectal examination (DRE) and a focused neurological exam. The International Prostate Symptom Score (IPSS) was recorded at the presentation. Initial investigations included a complete blood count, blood urea, serum creatinine, random blood sugar, serum electrolytes, coagulation profile, serum prostate-specific antigen (PSA), urine routine and microscopic examination, urine culture and sensitivity, chest X-ray, and electrocardiogram. An ultrasound of the kidney, ureter, and bladder (KUB) was performed to assess prostate size, evaluate the upper urinary tract, detect bladder pressure changes, and check for the presence of calculi. Uroflowmetry was conducted to measure flow rate parameters in patients with LUTS. Urodynamic studies (UDS) were performed in patients with a history of cerebrovascular accidents (CVA) to rule out underactive detrusor or neurogenic bladder. Once a diagnosis of benign prostatic hyperplasia (BPH) was confirmed, patients willing to participate in the study were randomized into two groups, with group 1 and group 2 undergoing TURP and thuvep respectively.

Informed and written consent for the proposed procedure was obtained, and part preparation was completed in the preoperative room just before the procedure. Patients fasted for 6–8 hours prior to surgery. An intravenous antibiotic was administered at the time of anesthesia induction. For ThuVEP, a 200-watt Quanta system laser machine with a 600 µm fiber and a standard 26 Fr resectoscope with the Kuntz working element (Richard–Wolf) or a 23 Fr RZ resectoscope was used, along with a Richard–Wolf Piranha morcellator with a morscelloscope. Settings of 80–120 watts and 40–50 watts were used for vapoenucleation and coagulation, respectively. Bipolar TURP was performed using a 26 Fr Karl Storz resectoscope sheath and a tungsten wire loop. At the end of both procedures, a 22 Fr triple lumen catheter was inserted into the bladder, and continuous flow normal saline irrigation was initiated and titrated as per the color of the urine. Traction was released after 4 hours and the catheter was removed on post-operative day 2 if the irrigation was clear to avoid bias of the surgeon. Patients were discharged after successful voiding.

An analytical between-group comparison was made of preoperative and peri-operative data including operation time, intraoperative blood loss by measuring spot hemoglobin on post-operative day 1, the requirement of post-op irrigation fluid volume, days of hospitalization, intra-operative and peri-operative complications with postoperative data (collected at 2 weeks, 6 weeks and 3 months after surgery) on IPSS, uroflowmetry with PVR, residual prostate size at 3 months. Post-operative complications like SUI, urinary tract infections urethral strictures, bladder neck stenosis, need for surgery for residual adenoma, were also compared.

A total of 68 patients were included in the study and randomized to 34 in each group.

Variables like age, serum PSA, serum creatinine, hemoglobin, catheterization history, comorbidities, prostate size and S. PSA, h/o prostatic biopsy, and any previous surgery were noted to be comparable between the two groups (table no.1 ).

Table 1: Preoperative characteristics in study groups.

(IPSS-International prostate symptom score, S.PSA: serum prostate specific antigen,Qmax; Peak flow rate,Qavg: Average flow rate,PVR: post void residual volume)

The mode of presentation among the study population included refractory acute urinary retention in 17 (25%) patients, LUTS unresponsive to medication in 46 (67.64 %) patients, and obstructive uropathy in 5 (7.35 %) patients.

Perioperative parameters:

The mean resection time was shorter in the ThuVEP group by 10 minutes. The intraoperative irrigation fluid requirement was comparable between the two groups.

The post-op irrigation fluid requirement was higher for Bipolar TURP compared to the ThuVEP group. The mean Post op hemoglobin decrease was more in the Bipolar TURP group than in the ThuVEP group. Post op Hospital stay was significantly higher in group bipolar than in group ThuVEP ( Table no.2)

Table 2: Perioperative parameters

Variable	B-TURP	S.D	ThuVEP	S.D	P-VALUE
Resection time (min)	90.15	14.64	80.59	15.26	0.01

Intraop volume of irrigation fluid (ltr)	29.21	4.51	27.53	3.91	0.10

Post op irrigation volume (ltr)	19.24	4.73	12.09	2.71	0.001

Post op hemoglobin decrease (gm%)	0.87	-	0.35	-	0.001

Hospital stay(hours)	61.06	15.80	49.15	11.38	0.001

S.D : Standard deviation

The occurrence of complications was similar between the two groups. (Table no.3)

Table 3 : Distribution of surgical complications across the two treatment groups.

Complications	Bipolar (34)	ThuLEP(34)	P -Value
1. Capsular/sinus perforation	1(2.9%)	3(8.8%)	0.61
2. Readmission	1(2.9%)	1(2.9%)	1
3. Re-Catheterization	1(2.9%)	1(2.9%)	1
4. SUI- Grade 1	4(11.76%)	3(8.82%)	1
5. SUI – Grade 2	1(2.9%)	1(2.9%)	1
6. SUI – Grade 3	0	0
7.Urinary tract infections	1(2.9)	3(8.8)	0.61
7. Urethral Stricture	0	0
8. Bladder Neck Stenosis	0	0

(SUI- stress urinary incontinence)

On follow up ThuVEP outperformed TURP in terms of peak flow rate, average flow rate, and residual prostate size (Table no.4), however, IPSS and PVR were comparable between the two groups.

Table 4 : Changes in uroflowmetry parameters on follow up

parameters	baseline	2 weeks	6 weeks	3 months
ipss- turp	23	8.64	5.62	3.94
Thuvep	24.3	7.58	4.82	2.79
P-VALUE	0.66	0.11	0.13	0.005

Qmax- turp	8.25	13.34	16.77	19.30
thuvep	8.51	15.67	19.08	25.41
P-VALUE	0.52	0.007	0.001	0.001

qavg- turp	3.91	6.96	8.45	10.07
THUVEP	3.94	8.05	9.39	12.17
P-VALUE	0.51	0.001	0.001	0.001

VOIDING TIMe- turp	43.72	18.38	16.29	14.76
THUVEP	42.91	18.06	16.68	15.18
P-VALUE	0.70	0.70	0.55	0.52

PVR TURP	127.59	48.88	29.36	28.76
THUVEP	104.16	41.55	28.00	24.14
P-VALUE	0.02	0.12	0.59	0.06

(IPSS-International prostate symptom score,Qmax(ml/sec); Peak flow rate,Qavg(ml/sec): Average flow rate,PVR(ml): post void residual volume)

The mean resection time is significantly lesser in the ThuVEP group(90.15 ± 14.64 minutes in the TURP group as compared to 80.59 ± 15.26 minutes in the ThuVEP group, P value < 0.05).A study done by Wei et al ¹² in 2013, showed no difference in operative time between the Thulium laser and Bipolar group. The shorter resection time can be attributed to simultaneous hemostasis and resection and high laser settings leading to simultaneous vaporisation and enucleation during ThuVEP, and the need to cauterize the prostatic bed for hemostasis is eliminated as in TURP.The post-operative traction time and catheterization time were equal in both groups as we fixed traction time to 4 hour and catheter removal on post-operative day 2 if the irrigation was clear. This was to avoid the bias of operating surgeons.

Hospital stay in our study was 61.06 ± 15.80 in the Bipolar TURP group and 49.85 ± 11.38 hour in the ThuVEP group (p < 0.001). Our results follow the results of the meta-analysis conducted by Yu Lan et al. 2016 ¹³, which showed shorter hospital stay

The post-op irrigation fluid requirement was higher for Bipolar TURP compared to the ThuVEP group. Post-op hemoglobin decrease was 0.87 gm% in bipolar TURP than group ThuVEP(0.47gm%). A statistically significant difference was found between the study groups, favoring the ThuVEP (p < 0.001). None of our study population required blood transfusion or developed TUR syndrome in the perioperative period.

The laser techniques and bipolar TURP have virtually eliminated TUR syndrome as a complication of endoscopic resection of large prostates because of use of saline as an irrigant solution along with reduced absorption due to simultaneous robust coagulation underneath while cutting or vaporizing. Multiple studies and meta-analyses supported the result of our study¹³. This finding could be explained by the excellent coagulation and hemostasis effect in thulium laser Vapoenucleation.

Over all stress urinary incontinence occurred in 5(14.70%) patients in the TURP group and in 4(11.76%) patients in the ThuVEP group (p-value − 1). Grade 1 SUI occurred in 4(11.76%) patients in the Bipolar TURP Group and 3(8.82%) in the ThuVEP group with no statistically significant difference between them. Gd II SUI occurred in 1 (2.9%) patients in both the Bipolar TURP and ThuVEP group. No patient had Gd III SUI. Incontinence was transient and disappeared completely at one month.In a meta-analysis conducted by Kun Tang et al¹⁴ in 2014, there was no statistically significant difference between Thulium laser and Bipolar TURP in catheterization, transitory urge incontinence, stress incontinence, UTI, and retrograde ejaculation.

Higher UTI infection was found in group ThuVEP (8.8%) than in group Bipolar (2.9%) which was statistically insignificant. (Table No.5) In a study by Gross et al¹⁵ (2012),6.9% of patients had uncomplicated urinary tract infections. Capsular perforation was found at 2.9% in group bipolar and 8.82% in group ThuVEP. The results were statistically insignificant. Readmission was required in one patient (2.9%) in each group, for redo surgery in the ThuVEP group and for hematuria needing clot evacuation in the bipolar group.

Table 5

Thulium laser noncomparative observational studies
Author Sample size Prostate size Median resection time Follow-up Complications
Gross et al. [2012]	1080 51	56		1	UTI-8.4% Transfusion-1.7%
Netsch et al [2013]	56 50		61.5	24	Transfusion-7.1%
Iacono et al. [2012]	148 108	70.03		12	UTI-12.8% Bladder injury-2.7% Transfusion-2.7%
Fu et al	72 65.8	56		12	Mild-moderate dysuria (8%)
Our Study [2024]	68 76.55	80.59		3	UTI-8.8% Transfusion-None Bladder injury-None

[Prostate size- cc, Resection time -minutes,Follow up-months]

In a study done by Sun et al in 20116¹⁶ showed reoperation as a result of BPH recurrence was required in 1.2% of patients over up to 8 years. Gross et al 2012¹⁵ showed a reoperation rate of 2.7% for residual prostate tissue. This finding was comparable to our study in which one patient (1.47%) from the ThuVEP group underwent reoperation. None of our patients developed urethral stricture or bladder neck stenosis which can be attributed to shorter follow-up in our study.

ThuVEP group had better Qmax, and Qavg at follow-up. The significant improvement in uroflowmetry parameters can be attributed to better vision due to simultaneous hemostasis leading to complete enucleation of the prostate and lesser residual prostate volume.In a study by Joon et al¹⁷ the increase in Qmax was much greater (8.9 ± 6.3 mL/s compared with 4.1 ± 2.9 mL/s, p<0.001) in the ThuVaRP group compared to the TURP group.

The baseline mean prostate size was 78.83 ± 15.98cc and 79.78 ± 13.45cc in the Bipolar TURP and ThuVEP group respectively. Ultrasound at 3 months assessed the prostate volume across both groups. The mean residual prostate volume at 3 months was significantly higher in group bipolar (32.91 ± 8.34) than in group ThuVEP (25.32 ± 6.13) which was found to be statistically significant with a p- p-value of 0.001, favoring the ThuVEP technique. In a study done by Joon Woo Kim et al in 2014, a comparable reduction in prostate volume was found ¹⁷.

We followed the patients for 3 months at the time of publication of results, late complications like stricture and bladder neck contracture will be assessed as continuation. Comparative studies with many patients and longer follow-ups are warranted to substantially validate the results and set a new gold standard.

To conclude, both Bipolar TURP and ThuVEP can be safely and efficiently used in larger prostates. However, ThuVEP outperforms Bipolar TURP in terms of blood loss, hospital stay, post-operative uroflow parameters, and residual prostate size. Both procedures are comparable in symptomatic relief and complications in peri and post-operative periods (IPSS was similar between the two groups).

Strengths:

Data regarding the comparison of these two modalities in low-income countries is scarce. Our study includes only larger prostates (> 60 cc). The results of this study could pave the way for further research on personalized treatment strategies for BPH, catering specifically to the unique healthcare challenges in low-income countries.

Establishing guidelines based on this comparative analysis could help standardize the management of BPH in low-income countries, ensuring that patients receive evidence-based treatments.

Limitations:

A larger sample size is needed to externally validate this study to general population.

Cost factor is not calculated in our study which has many implications in a developing countries.

BPH

Benign prostatic hypertrophy

TURP

transurethral resection of the prostate

ThuVEP

Thulium laser vapoenucleation of the prostate

IPSS

International prostate symptom score

PVR

Post void residual urine volume

SUI

stress urinary incontinence

Ethics approval and consent to participate:

This study was approved by the Institutional Ethics Committee ABVIMS & Dr. R.M.L. Hospital, New Delhi, India (Approval No: TP((DM/Mch/20/2022/IEC/ABVIMS/RMLH/1096, Date: 12 November 2022).

Consent for publication:

Informed consent was obtained from the patient for his/her anonymized information to be published in this article.

Competing interests:

None

Funding:

The authors declare that this study received no financial support.

Author Contribution

Author contributions:Study concept and design: HGData acquisition: NP , ASData analysis*: NP, SADrafting of manuscript*: HG, NP,AMCritical revision of the manuscript*: HG, AMCorresponding author: NP

Data Availability

The datasets generated and/or analysed during the current study are not publicly available due to informed consent about anonymity but are available from the corresponding author on reasonable request.

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No competing interests reported.

A prospective randomized comparative analysis of bipolar TURP and high-power Thulium vapoenucleation in the management of benign prostatic hyperplasia.

Status:

Version 1

Abstract

Background

Materials and Methods

Statistical analysis:

Study method and follow-up protocol:

Results

Discussion

[Prostate size- cc, Resection time -minutes,Follow up-months]

Conclusion

Strengths:

Limitations:

Abbreviations

Declarations