Clinical trial NCT06649357: Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate
Official title: Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate. A Prospective Randomized Multicentric Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Hyperplasia
Surgery
Endoscopic Anatomical Enucleation of the Prostate (EEAP)
Keywords: Prostate hyperplasia
Surgery
Endoscopic anatomical enucleation of the prostate (EEAP)
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 130
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who are candidates according to standard medical practice for BPH surgery with a prostate volume ≤ 80 cc measured by urological ultrasound or magnetic resonance imaging (MRI). Surgery will be randomly assigned using MoLEP or Bi-TURP.
Primary purpose: TREATMENT

Brief summary: Introduction: Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP), continuing to be considered by many the gold standard for surgical treatment of BPH.

Sofware and hardware upgrades to the Lumenis Pulse 120H. system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.

Primary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP.

Secondary objectives:

* To compare the surgical time of MoLEP with that of Bi-TURP.
* To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP.
* To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP.
* To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP.

This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice.

The study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment.

* The MoLEP group will receive surgical treatment with MoLEP.
* The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.

Detailed description: Introduction: The evolution of surgery for benign prostatic hyperplasia (BPH) has come a long way since Freyer described his technique of open adenomectomy over 100 years ago. The advancement of instruments and surgical techniques has made surgery increasingly les invasive. Transurethral resection of the prostate (TURP) allowed endoscopic treatment of BPH and it is still regarded by many as the gold-standard for BPH surgical treatment. The application of Holmium laser for endoscopic enucleation of the prostate (HoLEP) in the last 20 years has allowed for the surgical treatment of BPH through an endoscopic approach, practically without limitations in prostate size.

Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP) continuing to be considered by many the gold standard for surgical treatment of BPH.

However, the available studies often have short follow-up periods, most do not report on the surgeon's experience with HoLEP, and were based on early laser and morcellation technology. Sofware and hardware upgrades to the Lumenis Pulse 120H system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP, resulting in shorter enucleation, haemostasis, and total surgical times for similar energy delivered. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.

Hypothesis: MoLEP surgery is superior to Bi-TURP in terms of postoperative stay, bladder catheter duration, blood loss and transfusion rate, without significant functional outcomes, and retreatment rate, with no significant differences in surgical time.

Objectives:

Primary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP.

Secondary objectives:

* To compare the surgical time of MoLEP with that of Bi-TURP.
* To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP.
* To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP.
* To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP.

Study Design: This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice. The CONSORT guidelines for randomized clinical trials will be followed.

Participants: Patients who are candidates according to standard medical practice for BPH surgery with a prostate volume ≤ 80 cc measured by urological ultrasound or magnetic resonance imaging (MRI).

Intervention: The study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment.

* The MoLEP group will receive surgical treatment with MoLEP.
* The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.

Surgery and Follow-up Schedule:

* Surgeries will be conducted between November 2024 and April 2025
* Initial 6-month follow-up. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Completion of the first phase of the study: April 2026.
* Second phase follow-up: 24 months. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Dissemination of results: 2 months. Completion of the second phase of the study: October 2027
* Third phase follow-up: 5 years. Database construction and refinement: 2 months. Statistical analysis: 2 months. Preparation of the final report: 2 months. Dissemination of results: 2 months. Completion of the third phase of the study: October 2030.

Sample size calculation was calculated based on length of hospital stay. Previous studies indicate that the mean days of hospital stay is around 2,5 days in patients with RTU. The length of hospital stay for patients with MoLEP may be at least 1 day less. Around 10% of patients are treated with antiplatelet agents. In order to perform an analysis according to patients with and without this treatment, the sample size will be increased by 10%. Accepting an alpha risk of 5% and a beta risk of 20% in a two-tailed test, a total of 130 patients are needed (65 in each study group). A common standard deviation of 1 day is assumed. A loss to follow-up rate of 12% has been also estimated.

Statistical Analysis: Qualitative variables will be described with absolute frequencies and percentages. The description of quantitative variables will be performed using the mean, standard deviation (SD), median and quartiles. The Kolmogorov-Smirnov test will be used to assess the normality of distributions.

An initial bivariate intention to treat analysis will be performed in order to analyze potential differences according study groups. The relationship between two qualitative variables will be calculated using the chi-squared test or Fisher's exact test (frequency \<5). Quantitative variables will be compared using the Student's t-test (Mann Whitney. For non-normal distributions), analysis of variance \[ANOVA\] (\> 2 categories), linear regression test and Schea's multiple comparisons test. The linear relationship between the quantitative variables will be calculated using Pearson's correlation coefficient or Spearman's rank correlation test (when variable not normally distributed). Changes at the end of follow up in the main outcomes will be analyzed by Wilcoxon nonparametric test in the case of quantitative variables. The McNemar test will be used for the comparison of categorical variables. A backward stepwise linear regression analysis will be performed in order to determine which factors are independently associated to higher length of hospital stay. Study groups and variables with a p value \<0.2 in the univariate analysis will be included as independent variables. The results will be described with beta coefficient , 95% confidence interval (CI) and p-values. For all the tests, p-values \< 0.05 were considered statistically significant. The statistical package R Studio (V2.5.1) was used for the analyses.

Publications will be made with the results of the study, whether they are positive or negative. There will be at least 3 publication scheduled. This will be the results at 6 months, 2 years, and 5 years of follow up.

Eligibility criteria: Inclusion Criteria:

* Patients with maximum flow rate \< 15 ml/sec before obstructive surgery or with maximum flow rate \> 15 ml/sec and urodynamic study showing high-flow obstruction defined as bladder outlet obstruction index \> 40.
* Patients with moderate to severe lower urinary tract symptoms (LUTS) according to the International Prostate Symptom Score (IPSS). Score between 8 and 35.
* Patients with a prostate volume between 40 and 80 cc, measured by urological ultrasound or MRI.

Exclusion Criteria:

* History of prior prostatic obstructive or urethral surgery.
* Diagnosis of prostate neoplasia.
* Diagnosis of urothelial neoplasia.
* Lack of flowmetry or IPSS data before surgery.
* Diagnosis or suspicion of hypo/acontractile detrusor before prostatic obstructive surgery.
* Diagnosis or suspicion of neurogenic bladder or neurological disease.
* History of pelvic radiation therapy.

Primary outcomes:
measure: Postoperative hospital stay
timeFrame: From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month
Secondary outcomes:
measure: SURGICAL TIME
timeFrame: Total time of Surgery procedure
measure: The bladder catheterization time
timeFrame: Total time of bladder catheterization procedure
measure: Perioperative complications
timeFrame: From date of surgery to date of the end of follow-up 5 years
measure: TREATMENT
timeFrame: From date of surgery to date of the end of follow-up 5 years
measure: Urinary symptoms
timeFrame: From date of enrollment to date of the end of follow-up 5 years
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
state: A Coruña
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Univesitari de Bellvitge
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecillas
state: Cantabria
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Valladolid
country: Spain
facility: Hospital Universitario Río Ortega
Study officials:
affiliation: Fundacio Puigvert
name: Ivan Schwartzmann Jochamowitz, MD
role: PRINCIPAL_INVESTIGATOR
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