HoLEP Vs BPEP for Large Prostatic Adenoma

Prostate Hyperplasia Clinical Trial

— enucleation  

Official title:

Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04275076
• Other study ID #: FWA000017585.
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: June 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.

At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure.

Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy

Description:

Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL).

Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes.

Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy.

EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy.

Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries.

With such scarce information, the investigators aimed through this study to compare these two energy sources in the enucleation procedure of the prostate in terms of safety, efficacy, and cost-effectiveness in the management of BPH in large prostatic adenoma more than 80 ml.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:

1. Bothersome LUTS with an IPSS score over 19

2. Refractory hematuria

3. Upper urinary tract affection

4. Recurrent UTI secondary to prostatic enlargement

5. Maximum uroflow rate (Qmax) below 10 ml/sec.

6. bladder diverticula

7. Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.

Exclusion Criteria:

• Patients with:

1. Neurogenic bladder

2. Previous prostate or urethral surgery

3. Associated urethral stricture

4. Prostate cancer diagnosed by TRUS biopsy

5. Bladder stones,

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Maher Gamil Ahmed Higazy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	form the beginning of endoscopic procedure till catheter insertion	50-120 minutes
Secondary	Enucleation efficacy of HoLEP	Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams	12 months
Secondary	Enucleation efficacy of BEEP	Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams	12 months
Secondary	Mean energy in (HoLEP) in joules	Mean energy in (HoLEP) in joules	intra-operative finding
Secondary	irrigation fluid	Average Irrigation fluid used in each group in liters	intra-operative finding
Secondary	catheter removal time	postoperative time till catheter removal	1-7 days
Secondary	resected volume	resected volume in grams	intra-operative finding
Secondary	hemoglobin drop	blood loss in dl/ml	intra-operative finding
Secondary	conversion to other type of surgery	conversion to other types of surgeries like TURP, open surgery, procedure abortion	intra-operative finding
Secondary	Operative safety:	capsular perforation, Yes/No	intra-operative finding
Secondary	Operative safety:	morcellation injury, Yes/No	intra-operative finding
Secondary	early post operative complication	stress incontinence, Yes/No	1 month
Secondary	early post operative complication	urinary tract infection, Yes/No	1 month
Secondary	early post operative complication	urine retention, Yes/No	1 month
Secondary	Postoperative efficacy:	IPSS: international prostate symptom score	12 months
Secondary	Postoperative efficacy:	QoL: quality of life questionnaire	12 months
Secondary	Postoperative efficacy:	Qmax (m/sec.) : peak flow rate	12 months
Secondary	Postoperative efficacy:	PVRU (ml): post voiding residual urine	12 months
Secondary	Postoperative efficacy:	PSA (ng/ml): prostatic specific antigen	12 months
Secondary	Postoperative efficacy:	postoperative prostate volume assessment in grams	12 months
Secondary	cost effectiveness	Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group	12 months
Secondary	hospital stay	duration of postoperative hospital stay in days	1-7 days
Secondary	Cost analysis	average running cost evaluation in both procedure	1 year