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

• ClinicalTrials.gov Identifier: NCT04699552
• Recruitment Status: Withdrawn
• First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Sponsor: Indiana University
• Collaborator: Lumenis Ltd.
• Information provided by (Responsible Party): Marcelino Rivera, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Disease; Surgery	Device: 120W Lumenis Holmium:YAG laser 20J; Device: 120W Lumenis Holmium:YAG laser 40 J; Device: 120W Lumenis Holmium:YAG laser 60 J	Not Applicable

Detailed Description:

Study subjects will be identified by the clinical team or study coordinator either at the time surgery is scheduled or by review of the surgery schedule. Each subject will be screened for inclusion/exclusion criteria by reviewing the chart. If inclusion/exclusion criteria are met, the patient will be approached by a member of the research team for enrollment into the study. The patient must consent to participate by reviewing a study-specific, IRB-approved informed consent form before any study data is collected.

After informed consent has been obtained, a complete medical history including a detailed urologic history will be obtained prior to the HoLEP procedure. Standard pre-operative laboratory tests will be obtained, including a complete blood count, basic metabolic panel and urine culture.

Pre-operative, intra-operative and post-operative management of the patients included in this study will not differ from routine HoLEP treatment options described in the literature and practiced at our center. All laser settings examined are currently utilized. A complete description of the HoLEP procedure at our institution has previously been described15. Briefly, a 550um Lumenis MOSES fiber will be utilized. A 120W Holmium:YAG laser made by Lumenis will be used. Operatively, the time (minutes) for resection of the tissue will be recorded as "enucleation time". Once enucleation of the tissue has been completed, the time (in minutes) for complete removal of the enucleated tissue will be recorded as "morcellation time". Enucleated tissue can be removed by any means determined necessary by the surgeon, i.e. he/she may use the holmium laser or graspers in combination with the morcellator. Enucleation is typically performed in a stepwise fashion with an initial groove at the 5 and 7 o'clock position, followed by enucleation of the median lobe. The enucleation of the lateral lobes occurs in a bottom up approach. At times depending on patient anatomy an intraoperative decision by the treating surgeon may result in an early apical release. The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will differ from 20Hz, 40Hz and 60Hz between the three treatment arms. After enucleation, hemostasis is performed at a setting of 1J and 20 Hz with a widened pulse width for standard HoLEPs. For patients with a high median bar of bladder neck tissue, a single incision at the bladder neck is made at 6 o'clock. Total amount of laser energy utilized for the procedure will also be recorded.

Note will be made of concurrent procedures done at the time of HoLEP including: bladder calculi managed with cystolithopaxy or upper urinary tract calculi management.

Postoperative, patients will be provided with daily Twilio assessments of their postoperative dysuria, urgency and urgency urinary incontinence (as defined above) until it has resolved and remained symptom free x 3 consecutive days. Follow up Twilio assessments at 1month, 3month and 6months will be performed. Patients will concurrently follow up for standard postoperative face-to-face or virtual visit evaluations with their surgical team at 3months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Other
• Official Title: Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate: A Randomized Prospective Trial
• Estimated Study Start Date: December 2020
• Estimated Primary Completion Date: July 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 2J 20 Hz; 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; 120W Lumenis Holmium:YAG laser 20J
Experimental: 2J 40 Hz; 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; 120W Lumenis Holmium:YAG laser 40J
Experimental: 2J 60 Hz; 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; 120W Lumenis Holmium:YAG laser 60J

Outcome Measures

Primary Outcome Measures :

1. Rate of patient reported postoperative UUI [ Time Frame: 1 month ]
   Rate of patient reported postoperative UUI

Secondary Outcome Measures :

1. AE reported via Clavien-Dindo classification [ Time Frame: 24 hours ]
   AE reported via Clavien-Dindo classification
2. Time from HoLEP to postoperative dysuria resolution [ Time Frame: 90 days ]
   Time from HoLEP to postoperative dysuria resolution
3. Time from HoLEP to postoperative urgency resolution [ Time Frame: 90 days ]
   Time from HoLEP to postoperative urgency resolution
4. Enucleation/Operative time [ Time Frame: 24 hours ]
   Enucleation/Operative time
5. Total laser energy used [ Time Frame: 24 hours ]
   Total laser energy used
6. Perioperative change in hemoglobin [ Time Frame: 6 months ]
   Perioperative change in hemoglobin
7. Laser repair/maintenance rates [ Time Frame: 1 year ]
   Laser repair/maintenance rates
8. New postoperative urgency incontinence rates at 1month, 3months and 6months. [ Time Frame: 6 months ]
   New postoperative urgency incontinence rates at 1month, 3months and 6months.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Indiana

IU Methodist Hospital

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Lumenis Ltd.

Investigators

• Principal Investigator: Marcelino Rivera, MD; IU Health Physicians

More Information

Publications:

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.

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.

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.

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. Review.

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.

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.

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.

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.

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.

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.

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. Epub 2016 Oct 24.

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.

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.

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.

Rivera ME, Lingeman JE, Krambeck AE. Holmium Laser Enucleation of the Prostate. J Endourol. 2018 May;32(S1):S7-S9. doi: 10.1089/end.2017.0710.

• Responsible Party: Marcelino Rivera, Assistant Professor of Urology, Indiana University
• ClinicalTrials.gov Identifier: NCT04699552
• Other Study ID Numbers: 2010195334
• First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Marcelino Rivera, Indiana University:

Holmium Laser Enucleation; Prostate

Additional relevant MeSH terms:

Prostatic Diseases