Skip to content

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04561505
Enrollment
60
Registered
2020-09-23
Start date
2018-02-01
Completion date
2020-02-29
Last updated
2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Keywords

prostate, transurethral resection of prostate, HoLEP

Brief summary

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.

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.

Interventions

surgical management of BPH by Holmium laser enucleation using 0.9% saline fluid for irrigation

PROCEDUREmonopolar transurethral resection of prostate

surgical management of BPH by monopolar TURP using distilled water for irrigation

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the international prostate symptom score (IPSS)1 yearassessing the improvement of IPSS
maximum urine flow rate (Qmax)1 yearassessing the improvement of Qmax

Secondary

MeasureTime frameDescription
resected volumeimmediately postoperativemeasuring the resected volume of prostate after each operation
postoperative drop in hemaoglobin level1 day postoperativecomparing postoperative hemoglobin level with preoperative level in both groups
postoperative drop in sodium level1 day postoperativecomparing postoperative sodium level with preoperative level in both groups
duration of hospital stay3 days postoperativeassessing duration of hospital stay in both groups
postvoiding residual urine volume1 yearassessing postvoiding residual urine volume in both groups
ultrasound assessed prostate volume1 yearcomparing ultrasound assessed prostate volume in both groups
postoperative catheterization time4 days postoperativeassessing postoperative catheterization time in both groups
operative timeimmediately postoperativeestimating the operative time in both groups in minutes

Other

MeasureTime frameDescription
cost analysis3 days postoperativecomparing 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.
complications1 yearassessing intraoperative, early postoperative and late postoperative complications in both groups

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026