Clinical trial NCT04386941: Greenlight Vaporization vs Xpeeda Vaporesection
Official title: Holmium Laser Xpeeda Vaporesection Versus Greenlight XPS Vaporization of the Prostate for Benign Prostatic Obstruction: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Lead sponsor: Thunder Bay Regional Health Research Institute
Sponsor class: OTHER
Collaborators: name: Northern Ontario School of Medicine
name: Thunder Bay Regional Health Sciences Centre
First posted: 2020-05-13
Enrollment: 97
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized clinical study
Primary purpose: DIAGNOSTIC

Brief summary: Bothersome lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is a common problem, which impact patients' quality of life. It may lead to serious outcomes, including urinary tract infection, hematuria, bladder stones, urinary retention, hydronephrosis, and rarely renal insufficiency.

Introduction of the Holmium laser enucleation of the prostate (HoLEP) represented a turning point in minimally invasive laser therapy for BPH as it achieves size-independent prostatic cavities similar to simple open prostatectomy with significantly lower perioperative morbidity.

Recently, Holmium Xpeeda side firing fibre was introduced and it stands apart from other available technologies as a combination of power and efficiency, which minimizes vaporization time. This technology seems to revolutionize utilization of the Holmium power and delivering more energy directly to the tissue, due to its capability of being in contact with the tissue.

To date, no outcomes of the new Xpeeda laser fiber have been reported in the literature, which is striving for trials comparing XPS 180W with other competitors such as Holmium vaporesection with the new fiber Xpeeda. Therefore, this study is planned to compare both procedures in improving bothersome LUTS secondary to BPH, and to evaluate safety and cost effectiveness.

Detailed description: Bothersome lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is a common problem, which impact patients' quality of life. It may lead to serious outcomes, including urinary tract infection, hematuria, bladder stones, urinary retention, hydronephrosis, and rarely renal insufficiency. Symptoms of BPH are due to prostatic enlargement, increased smooth muscle tone from the bladder and prostate, and changes in bladder contractility leading to lower urinary tract obstruction, which may cause permanent kidney damage if left untreated.

Introduction of the Holmium laser enucleation of the prostate (HoLEP) represented a turning point in minimally invasive laser therapy for BPH as it achieves size-independent prostatic cavities similar to simple open prostatectomy with significantly lower perioperative morbidity. It has successfully passed the steps of validation through a growing number of well-designed randomized controlled studies to have a high level of evidence for safety and efficacy. The pulsed nature of holmium laser allows the plane of enucleation to be easier to develop and follow and gives superior visibility than the electro-cauterization with less charring of tissue.

HoLEP proved itself as the only endoscopic procedure with superior efficacy compared to the traditional transurethral resection of the prostate (TURP). Furthermore, it is not only safe, effective, size-independent and durable even in patients with coagulopathy, but also more cost-effective than TURP. Meta-analyses have confirmed how well established HoLEP has now become, with a low long-term retreatment rate and the more pronounced improvement in prostate symptoms score and flow rate than after TURP.

Recently, Holmium Xpeeda side firing fibre was introduced and it stands apart from other available technologies as a combination of power and efficiency, which minimizes vaporization time. This technology seems to revolutionize utilization of the Holmium power and delivering more energy directly to the tissue, due to its capability of being in contact with the tissue. Moreover, hemostasis would be improved by the pulse reshaping technology with a wider pulse width, activated by a dedicated footswitch. Therefore, the Lumenis Pulse™ 100W will make prostate vaporesection procedures more precise, faster and efficient, with excellent hemostasis. Consequently, bleeding is minimal, tissue is easier to remove and patients can have their catheter removed faster.

On the other hand, Greenlight 532nm laser photoselective vaporization of the prostate (PVP) is an appealing treatment modality with hemoglobin as tissue target chromophore and relatively short learning curve. The introduction of the Xcelerated Performance System (XPS) 180W in 2010 with the MoXy fibres represents the highest-powered system currently in use for this type of laser. It encourages the adoption of the enucleation principle, making it a real contender to HoLEP in treating large adenomas. Despite the fact that large prostates often require more energy and longer operative time, the XPS system has reduced the operative time and number of fibres required in these situations.

Elmansy et al reported that Greenlight vaporization and Holmium laser ablation of the prostate (HoLAP) are effective surgical treatments for BPH in small to medium prostates. The two techniques have similar functional outcomes and complication rates. Subjective and objective voiding parameters showed significant improvement lasting for up to 3 years, confirming the long lasting, durable effects of each technique.

To date, no outcomes of the new Xpeeda laser fiber have been reported in the literature, which is striving for trials comparing XPS 180W with other competitors such as Holmium vaporesection with the new fiber Xpeeda. Therefore, this study is planned to compare both procedures in improving bothersome LUTS secondary to BPH, and to evaluate safety and cost effectiveness.

Eligibility criteria: Inclusion Criteria:

1. Males over 50 years of age at the time of enrollment
2. Referred to urology for refractory LUTS secondary to BPH
3. Prostate size on preoperative TRUS of 40-80 ml
4. IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec
5. Written informed consent to participate in the study
6. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

1. Previous surgical treatment for BPH
2. Presence of bladder stones
3. History of prostate cancer
4. Prostate size \> 80 mL or \<40 mL
5. History of urethral stenosis or its management
6. Known or suspected neurogenic bladder
7. Participants with active urinary tract infection until appropriately treated
8. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
9. Participants who are uncooperative or cannot follow instructions.
10. Participants who lack the capacity to provide free and informed written consent.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: Baseline
measure: International Prostate Symptom Score (IPSS)
timeFrame: 1 month post-op
measure: International Prostate Symptom Score (IPSS)
timeFrame: 3 months post-op
measure: International Prostate Symptom Score (IPSS)
timeFrame: 6 months post-op
measure: International Prostate Symptom Score (IPSS)
timeFrame: 12 months post-op
measure: Quality of life (QOL) Due to Urinary Symptoms
timeFrame: Baseline
measure: Quality of life (QOL) Due to Urinary Symptoms
timeFrame: 1 month post-op
measure: Quality of life (QOL) Due to Urinary Symptoms
timeFrame: 3 months post-op
measure: Quality of life (QOL) Due to Urinary Symptoms
timeFrame: 6 months post-op
measure: Quality of life (QOL) Due to Urinary Symptoms
timeFrame: 12 months post-op
measure: Peak flow rate (Qmax)
timeFrame: Baseline
measure: Peak flow rate (Qmax)
timeFrame: Immediately post-catheter removal
measure: Peak flow rate (Qmax)
timeFrame: 1 month post-op
measure: Peak flow rate (Qmax)
timeFrame: 3 months post-op
measure: Peak flow rate (Qmax)
timeFrame: 6 months post-op
measure: Peak flow rate (Qmax)
timeFrame: 12 months post-op
measure: Post-void residual urine volume (PVR)
timeFrame: Baseline
measure: Post-void residual urine volume (PVR)
timeFrame: Immediately post-catheter removal
measure: Post-void residual urine volume (PVR)
timeFrame: 1 month post-op
measure: Post-void residual urine volume (PVR)
timeFrame: 3 months post-op
measure: Post-void residual urine volume (PVR)
timeFrame: 6 months post-op
measure: Post-void residual urine volume (PVR)
timeFrame: 12 months post-op
measure: Prostate specific antigen (PSA)
timeFrame: Baseline
measure: Prostate specific antigen (PSA)
timeFrame: 3 months post-op
measure: Prostate specific antigen (PSA)
timeFrame: 12 months post-op
Secondary outcomes:
measure: Rates of intraoperative adverse events
timeFrame: During surgery
measure: Degree of prostatic size change measured by transrectal ultrasound (TRUS)
timeFrame: Surgery and 3-months post-op
measure: International index of erectile function-5 (IIEF-5)
timeFrame: Surgery
measure: International index of erectile function-5 (IIEF-5)
timeFrame: 3 months post-op
measure: International index of erectile function-5 (IIEF-5)
timeFrame: 12 months post-op
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute
state: Ontario
Study officials:
affiliation: Thunder Bay Regional Health Sciences Centre
name: Hazem Elmansy, MD
role: PRINCIPAL_INVESTIGATOR
References: