HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia

Holmium Laser Enucleation of the Prostate Versus Monopolar Transurethral Resection of the Prostate in Management of Benign Prostatic Hyperplasia.

To compare the clinical outcome regarding safety and efficacy between Holmium laser enucleation of the prostate and transurethral resection of the prostate in management of benign prostatic hyperplasia.

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Holmium laser enucleation of prostate; Procedure: monopolar transurethral resection of prostate

Detailed Description

Benign prostatic hyperplasia (BPH) affects 70% of men older than 70 years and is a significant cause of morbidity in this population.

The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.

Lower urinary tract symptoms (LUTS) in elderly men are mainly related to an enlarged prostate, the actual link between an enlarged prostate and the onset of symptoms are multifactorial.

LUTS include both irritative symptoms in the form of urgency, frequency, nocturnal enuresis and urge incontinence as well as obstructive symptoms comprise hesitancy, weak interrupted stream of urine, incomplete voiding which eventually affect the quality of life (QoL), the main goal of treatment is resolve these symptom.

Multiple surgical options are available for management of benign prostatic hyperplasia (BPH) and its associated symptoms. Transurethral resection of the prostate (TURP) and open prostatectomy remain the gold standard surgical management. However, considerable morbidities are associated with both procedures and mainly related to the prostate size.

These complications may be either patient or surgically related. The patient's related complications are cardiac arrhythmia, myocardial infarction, pulmonary embolism, exacerbation of previous respiratory disease, deep venous thrombosis and death. The surgical related complication includes bleeding, capsular perforation, urosepsis, incontinence, conversion to open surgery, bladder neck stenosis, redo surgery and transurethral resection syndrome.

Clearly, a wide gap existed between simple medical therapy on one hand and TURP on the other hand. This wide gap is coupled with the need for a less morbid alternative to TURP that led to the emergence of various less invasive therapy among which Laser based minimally invasive procedure.

Modern laser therapy for BPH has advantages over TURP including decreased blood loss and minimal serum electrolyte changes resulting in fewer cardiovascular complications, decreased catheter time, shorter hospital stay and the ability to treat patients on anticoagulation.

Because of these potential advantages, there has been a shift in practice patterns with laser procedures accounting for 57% of surgical interventions for BPH, compared to traditional TURP which accounted for only 39% of interventions in 2005.

Holmium laser enucleation of the prostate (HoLEP) is the most recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe and effective surgical procedure, which has comparable results to transurethral resection of the prostate (TURP) and open prostatectomy, with low morbidity and short hospital stay.

HoLEP is equally suitable for small, medium, and large prostate glands, with clinical outcomes that are independent of prostate size, and recently it has been proposed as a new gold standard for treatment of symptomatic benign prostatic hyperplasia (BPH). Currently, all BPH guidelines recommend HoLEP as a surgical treatment of BPH.

For a procedure to be considered a gold standard, it must provide effective results, low morbidity, and durable outcomes. HoLEP, as many of the new alternative treatments for symptomatic BPH, has scanty data regarding its role in Egyptian population and if it can replace TURP to be the gold standard.

To our best knowledge, no one estimated cost effectiveness between the two techniques in a developing country.

Our study aimed to compare the efficacy, safety and cost effectiveness of HoLEP versus monopolar TURP in management of benign prostatic hyperplasia in a developing country.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11361
    • AinShams University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• prostate volume less than 80 ml
• high IPSS more than 19 affecting quality of life
• recurrent urinary retention with failure of medical treatment
• recurrent urinary tract infection
• affection of upper urinary tract
• refractory hematuria
• bladder stones
• bladder diverticula

Exclusion Criteria:

• patients with neurogenic bladder
• patients with previous prostate or urethral surgery
• associated urethral stricture
• prostate cancer diagnosed by TRUS biopsy
• prostate volume more than 80 ml

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Holmium laser enucleation of prostate; patients that undergo Holmium laser enucleation of prostate (HoLEP) procedure	Procedure: Holmium laser enucleation of prostate; surgical management of BPH by Holmium laser enucleation using 0.9% saline fluid for irrigation
Active Comparator: monopolar transurethral resection of prostate; patients that undergo monopolar transurethral resection of prostate	Procedure: monopolar transurethral resection of prostate; surgical management of BPH by monopolar TURP using distilled water for irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the international prostate symptom score (IPSS)	assessing the improvement of IPSS	1 year
maximum urine flow rate (Qmax)	assessing the improvement of Qmax	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	estimating the operative time in both groups in minutes	immediately postoperative
resected volume	measuring the resected volume of prostate after each operation	immediately postoperative
postoperative drop in hemaoglobin level	comparing postoperative hemoglobin level with preoperative level in both groups	1 day postoperative
postoperative drop in sodium level	comparing postoperative sodium level with preoperative level in both groups	1 day postoperative
postoperative catheterization time	assessing postoperative catheterization time in both groups	4 days postoperative
duration of hospital stay	assessing duration of hospital stay in both groups	3 days postoperative
postvoiding residual urine volume	assessing postvoiding residual urine volume in both groups	1 year
ultrasound assessed prostate volume	comparing ultrasound assessed prostate volume in both groups	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
cost analysis	comparing cost analysis for each patient in both groups as regards running cost including laser fiber or monopolar loop, irrigation fluid and cost of hospital stay.	3 days postoperative
complications	assessing intraoperative, early postoperative and late postoperative complications in both groups	1 year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Salah Sayed, master, assistant lecturer of urology, Ainshams university hospital, Cairo, Egypt; Study Chair: Amr Elshorbagy, PhD, professor of urology, Ainshams university hospital, Cairo, Egypt; Study Chair: Mahmoud A. Mahmoud, PhD, assistant professor of urology, Ainshams university hospital, Cairo, Egypt; Study Director: Diaaeldin Mostafa, PhD, assistant professor of urology, Ainshams university hospital, Cairo, Egypt

Publications and helpful links

General Publications

• Magoha GA. Medical management of benign prostatic hyperplasia: a review. East Afr Med J. 1996 Jul;73(7):453-6.
• Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'dow J, Nordling J, de la Rosette JJ; European Association of Urology. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013 Jul;64(1):118-40. doi: 10.1016/j.eururo.2013.03.004. Epub 2013 Mar 13.
• Biester K, Skipka G, Jahn R, Buchberger B, Rohde V, Lange S. Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority). BJU Int. 2012 Mar;109(5):722-30. doi: 10.1111/j.1464-410X.2011.10512.x. Epub 2011 Aug 22.
• Bach T, Muschter R, Sroka R, Gravas S, Skolarikos A, Herrmann TR, Bayer T, Knoll T, Abbou CC, Janetschek G, Bachmann A, Rassweiler JJ. Laser treatment of benign prostatic obstruction: basics and physical differences. Eur Urol. 2012 Feb;61(2):317-25. doi: 10.1016/j.eururo.2011.10.009. Epub 2011 Oct 21.
• Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention. Eur Urol. 2006 Nov;50(5):969-79; discussion 980. doi: 10.1016/j.eururo.2005.12.042. Epub 2006 Jan 30.
• Pearce SM, Pariser JJ, Malik RD, Famakinwa OJ, Chung DE. Outcomes following Thulium vapoenucleation of large prostates. Int Braz J Urol. 2016 Jul-Aug;42(4):757-65. doi: 10.1590/S1677-5538.IBJU.2015.0424.
• Yu X, Elliott SP, Wilt TJ, McBean AM. Practice patterns in benign prostatic hyperplasia surgical therapy: the dramatic increase in minimally invasive technologies. J Urol. 2008 Jul;180(1):241-5; discussion 245. doi: 10.1016/j.juro.2008.03.039. Epub 2008 May 21.
• Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): the endourologic alternative to open prostatectomy. Eur Urol. 2006 Jan;49(1):87-91. doi: 10.1016/j.eururo.2005.08.015. Epub 2005 Nov 2.
• Kuntz RM, Lehrich K, Ahyai S. Does perioperative outcome of transurethral holmium laser enucleation of the prostate depend on prostate size? J Endourol. 2004 Mar;18(2):183-8. doi: 10.1089/089277904322959842.
• Kuntz RM. Current role of lasers in the treatment of benign prostatic hyperplasia (BPH). Eur Urol. 2006 Jun;49(6):961-9. doi: 10.1016/j.eururo.2006.03.028. Epub 2006 Mar 31.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: prostate; transurethral resection of prostate; HoLEP
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: HoLEP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No