NCT04561505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 18, 2020

Last Update Submit

September 18, 2020

Conditions

Prostatic Hyperplasia

Keywords

prostatetransurethral resection of prostateHoLEP

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • operative time

    immediately postoperative

  • resected volume

    immediately postoperative

  • postoperative drop in hemaoglobin level

    1 day postoperative

  • postoperative drop in sodium level

    1 day postoperative

  • postoperative catheterization time

    4 days postoperative

  • +3 more secondary outcomes

Other Outcomes (2)

  • cost analysis

    3 days postoperative

  • complications

    1 year

Study Arms (2)

Holmium laser enucleation of prostate

ACTIVE COMPARATOR

patients that undergo Holmium laser enucleation of prostate (HoLEP) procedure

Procedure: Holmium laser enucleation of prostate

monopolar transurethral resection of prostate

ACTIVE COMPARATOR

patients that undergo monopolar transurethral resection of prostate

Procedure: monopolar transurethral resection of prostate

Interventions

Holmium laser enucleation of prostatePROCEDURE

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

Holmium laser enucleation of prostate
monopolar transurethral resection of prostatePROCEDURE

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

monopolar transurethral resection of prostate

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales only have prostate that will need surgical management of BPH
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams university hospital

Cairo, 11361, Egypt

Location

Related Publications (10)

  • Magoha GA. Medical management of benign prostatic hyperplasia: a review. East Afr Med J. 1996 Jul;73(7):453-6.

    PMID: 8918007BACKGROUND

  • 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.

    PMID: 23541338BACKGROUND

  • 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.

    PMID: 21883855BACKGROUND

  • 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.

    PMID: 22033173BACKGROUND

  • 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.

    PMID: 16469429BACKGROUND

  • 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.

    PMID: 27564287BACKGROUND

  • 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.

    PMID: 18499180BACKGROUND

  • 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.

    PMID: 16314033BACKGROUND

  • 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.

    PMID: 15072628BACKGROUND

  • 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.

    PMID: 16632179BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Salah Sayed, master

    assistant lecturer of urology, Ainshams university hospital, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

  • Diaaeldin Mostafa, PhD

    assistant professor of urology, Ainshams university hospital, Cairo, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 23, 2020

Study Start

February 1, 2018

Primary Completion

February 1, 2020

Study Completion

February 29, 2020

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations

EG(1)