Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate

NCT04699552 | Withdrawn FDA Device

• 1 other identifier: 2010195334
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and outcomes, such as postoperative dysuria (pain during urination), urgency (frequent need to urinate) and urinary incontinence (leaking urine or inability to hold urine), of 3 different HoLEP laser settings.

Conditions

Prostate Disease; Surgery

Keywords

Holmium Laser Enucleation; Prostate

Outcome Measures

Primary Outcomes (1)

• Rate of patient reported postoperative UUI

  Rate of patient reported postoperative UUI

  1 month

Secondary Outcomes (8)

• AE reported via Clavien-Dindo classification

  24 hours

• Time from HoLEP to postoperative dysuria resolution

  90 days

• Time from HoLEP to postoperative urgency resolution

  90 days

• Enucleation/Operative time

  24 hours

• Total laser energy used

  24 hours

Study Arms (3)

2J 20 Hz

EXPERIMENTAL

The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 20Hz

Device: 120W Lumenis Holmium:YAG laser 20J

2J 40 Hz

EXPERIMENTAL

The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 40Hz

Device: 120W Lumenis Holmium:YAG laser 40 J

2J 60 Hz

EXPERIMENTAL

The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 60Hz

Device: 120W Lumenis Holmium:YAG laser 60 J

Interventions

120W Lumenis Holmium:YAG laser 20J DEVICE

120W Lumenis Holmium:YAG laser 20J

2J 20 Hz

120W Lumenis Holmium:YAG laser 40 J DEVICE

120W Lumenis Holmium:YAG laser 40J

2J 40 Hz

120W Lumenis Holmium:YAG laser 60 J DEVICE

120W Lumenis Holmium:YAG laser 60J

2J 60 Hz

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
• Able to give informed consent.
• Age 18 years or older.

You may not qualify if:

• Inability to give informed consent.
• Age less than 18 years.

Sponsors & Collaborators

• Indiana University: lead
• Lumenis Be Ltd.: collaborator

Study Sites (1)

IU Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (15)

• Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.

  PMID: 6206240 BACKGROUND

• Gilling PJ, Kennett K, Das AK, Thompson D, Fraundorfer MR. Holmium laser enucleation of the prostate (HoLEP) combined with transurethral tissue morcellation: an update on the early clinical experience. J Endourol. 1998 Oct;12(5):457-9. doi: 10.1089/end.1998.12.457.

  PMID: 9847070 BACKGROUND

• Tan AH, Gilling PJ, Kennett KM, Frampton C, Westenberg AM, Fraundorfer MR. A randomized trial comparing holmium laser enucleation of the prostate with transurethral resection of the prostate for the treatment of bladder outlet obstruction secondary to benign prostatic hyperplasia in large glands (40 to 200 grams). J Urol. 2003 Oct;170(4 Pt 1):1270-4. doi: 10.1097/01.ju.0000086948.55973.00.

  PMID: 14501739 BACKGROUND

• Tan A, Liao C, Mo Z, Cao Y. Meta-analysis of holmium laser enucleation versus transurethral resection of the prostate for symptomatic prostatic obstruction. Br J Surg. 2007 Oct;94(10):1201-8. doi: 10.1002/bjs.5916.

  PMID: 17729384 BACKGROUND

• McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.

  PMID: 21420124 BACKGROUND

• Salonia A, Suardi N, Naspro R, Mazzoccoli B, Zanni G, Gallina A, Bua L, Scattoni V, Rigatti P, Montorsi F. Holmium laser enucleation versus open prostatectomy for benign prostatic hyperplasia: an inpatient cost analysis. Urology. 2006 Aug;68(2):302-6. doi: 10.1016/j.urology.2006.02.007.

  PMID: 16904441 BACKGROUND

• Elhilali MM, Badaan S, Ibrahim A, Andonian S. Use of the Moses Technology to Improve Holmium Laser Lithotripsy Outcomes: A Preclinical Study. J Endourol. 2017 Jun;31(6):598-604. doi: 10.1089/end.2017.0050. Epub 2017 Apr 25.

  PMID: 28340540 BACKGROUND

• Large T, Nottingham C, Stoughton C, Williams J Jr, Krambeck A. Comparative Study of Holmium Laser Enucleation of the Prostate With MOSES Enabled Pulsed Laser Modulation. Urology. 2020 Feb;136:196-201. doi: 10.1016/j.urology.2019.11.029. Epub 2019 Nov 30.

  PMID: 31790785 BACKGROUND

• Houssin V, Olivier J, Brenier M, Pierache A, Laniado M, Mouton M, Theveniaud PE, Baumert H, Mallet R, Marquette T, Villers A, Robert G, Rizk J. Predictive factors of urinary incontinence after holmium laser enucleation of the prostate: a multicentric evaluation. World J Urol. 2021 Jan;39(1):143-148. doi: 10.1007/s00345-020-03169-0. Epub 2020 Mar 26.

  PMID: 32219512 BACKGROUND

• Kobayashi S, Yano M, Nakayama T, Kitahara S. Predictive risk factors of postoperative urinary incontinence following holmium laser enucleation of the prostate during the initial learning period. Int Braz J Urol. 2016 Jul-Aug;42(4):740-6. doi: 10.1590/S1677-5538.IBJU.2015.0477.

  PMID: 27564285 BACKGROUND

• Hur WS, Kim JC, Kim HS, Koh JS, Kim SH, Kim HW, Cho SY, Cho KJ. Predictors of urgency improvement after Holmium laser enucleation of the prostate in men with benign prostatic hyperplasia. Investig Clin Urol. 2016 Nov;57(6):431-436. doi: 10.4111/icu.2016.57.6.431. Epub 2016 Oct 24.

  PMID: 27847917 BACKGROUND

• Becker B, Gross AJ, Netsch C. Safety and efficacy using a low-powered holmium laser for enucleation of the prostate (HoLEP): 12-month results from a prospective low-power HoLEP series. World J Urol. 2018 Mar;36(3):441-447. doi: 10.1007/s00345-017-2159-5. Epub 2017 Dec 23.

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• Elshal AM, El-Nahas AR, Ghazy M, Nabeeh H, Laymon M, Soltan M, Ghobrial FK, El-Kappany HA. Low-Power Vs High-Power Holmium Laser Enucleation of the Prostate: Critical Assessment through Randomized Trial. Urology. 2018 Nov;121:58-65. doi: 10.1016/j.urology.2018.07.010. Epub 2018 Jul 19.

  PMID: 30031005 BACKGROUND

• Stern KL, McAdams SB, Cha SS, Abdul-Muhsin HM, Humphreys MR. A New Laser Platform for Holmium Laser Enucleation of the Prostate: Does the Lumenis Pulse 120H Laser Platform Improve Enucleation Efficiency? Urology. 2017 Apr;102:198-201. doi: 10.1016/j.urology.2016.12.022. Epub 2016 Dec 23.

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  PMID: 29774816 BACKGROUND

MeSH Terms

Conditions

Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marcelino Rivera, MD

  IU Health Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Treating surgeons will know the randomization at the time of the operation however the postoperative data analysis and results will be performed by the research team in a blinded fashion when examining clinical outcomes and adverse events
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: December 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)