Clinical trial NCT04561505: HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia
Official title: Holmium Laser Enucleation of the Prostate Versus Monopolar Transurethral Resection of the Prostate in Management of Benign Prostatic Hyperplasia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hyperplasia
Keywords: prostate
transurethral resection of prostate
HoLEP
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the international prostate symptom score (IPSS)
timeFrame: 1 year
measure: maximum urine flow rate (Qmax)
timeFrame: 1 year
Secondary outcomes:
measure: operative time
timeFrame: immediately postoperative
measure: resected volume
timeFrame: immediately postoperative
measure: postoperative drop in hemaoglobin level
timeFrame: 1 day postoperative
measure: postoperative drop in sodium level
timeFrame: 1 day postoperative
measure: postoperative catheterization time
timeFrame: 4 days postoperative
measure: duration of hospital stay
timeFrame: 3 days postoperative
measure: postvoiding residual urine volume
timeFrame: 1 year
measure: ultrasound assessed prostate volume
timeFrame: 1 year
Other outcomes:
measure: cost analysis
timeFrame: 3 days postoperative
measure: complications
timeFrame: 1 year
Locations:
city: Cairo
country: Egypt
facility: Ainshams university hospital
Study officials:
affiliation: assistant lecturer of urology, Ainshams university hospital, Cairo, Egypt
name: Salah Sayed, master
role: PRINCIPAL_INVESTIGATOR
affiliation: professor of urology, Ainshams university hospital, Cairo, Egypt
name: Amr Elshorbagy, PhD
role: STUDY_CHAIR
affiliation: assistant professor of urology, Ainshams university hospital, Cairo, Egypt
name: Mahmoud A. Mahmoud, PhD
role: STUDY_CHAIR
affiliation: assistant professor of urology, Ainshams university hospital, Cairo, Egypt
name: Diaaeldin Mostafa, PhD
role: STUDY_DIRECTOR
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