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

Surgery Clinical Trial

Official title:

Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate: A Randomized Prospective Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04699552
• Other study ID #: 2010195334
• Status: Withdrawn
• Phase: N/A
• Start date: December 2020
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Disease
• Prostatic Diseases
• Surgery

Intervention

Device:
• 120W Lumenis Holmium:YAG laser 20J
120W Lumenis Holmium:YAG laser 20J
• 120W Lumenis Holmium:YAG laser 40 J
120W Lumenis Holmium:YAG laser 40J
• 120W Lumenis Holmium:YAG laser 60 J
120W Lumenis Holmium:YAG laser 60J

Locations

Country	Name	City	State
United States	IU Methodist Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Lumenis Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2020 Mar 26. doi: 10.1007/s00345-020-03169-0. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patient reported postoperative UUI	Rate of patient reported postoperative UUI	1 month
Secondary	AE reported via Clavien-Dindo classification	AE reported via Clavien-Dindo classification	24 hours
Secondary	Time from HoLEP to postoperative dysuria resolution	Time from HoLEP to postoperative dysuria resolution	90 days
Secondary	Time from HoLEP to postoperative urgency resolution	Time from HoLEP to postoperative urgency resolution	90 days
Secondary	Enucleation/Operative time	Enucleation/Operative time	24 hours
Secondary	Total laser energy used	Total laser energy used	24 hours
Secondary	Perioperative change in hemoglobin	Perioperative change in hemoglobin	6 months
Secondary	Laser repair/maintenance rates	Laser repair/maintenance rates	1 year
Secondary	New postoperative urgency incontinence rates at 1month, 3months and 6months.	New postoperative urgency incontinence rates at 1month, 3months and 6months.	6 months