Prostate DiseaseNCT04699552
Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate
A study testing 120W Lumenis Holmium:YAG laser 20J, 120W Lumenis Holmium:YAG laser 40 J and 120W Lumenis Holmium:YAG laser 60 J in people with Prostate Disease and Surgery, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Disease, Surgery
- What is being tested?
- 120W Lumenis Holmium:YAG laser 20J, 120W Lumenis Holmium:YAG laser 40 J and 120W Lumenis Holmium:YAG laser 60 J
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
- Able to give informed consent.
- Age 18 years or older.
Who cannot join
- Inability to give informed consent.
- Age less than 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate: A Randomized Prospective Trial
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.
Read the 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.
- Conditions
- Prostate Disease, Surgery
- Being tested
- 120W Lumenis Holmium:YAG laser 20J, 120W Lumenis Holmium:YAG laser 40 J, 120W Lumenis Holmium:YAG laser 60 J
- Keywords
- Holmium Laser Enucleation, Prostate
- Medical subject headings
- Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
120W Lumenis Holmium:YAG laser 20JDevice
120W Lumenis Holmium:YAG laser 20J
120W Lumenis Holmium:YAG laser 40 JDevice
120W Lumenis Holmium:YAG laser 40J
120W Lumenis Holmium:YAG laser 60 JDevice
120W Lumenis Holmium:YAG laser 60J
| Study group | Role | What they receive |
|---|---|---|
| 2J 20 Hz | Experimental | The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 20Hz Receives: 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 Receives: 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 Receives: Device: 120W Lumenis Holmium:YAG laser 60 J |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patient reported postoperative UUI
Rate of patient reported postoperative UUI
Measured: 1 month
Secondary outcomes (8)
AE reported via Clavien-Dindo classification
AE reported via Clavien-Dindo classification
Measured: 24 hours
Time from HoLEP to postoperative dysuria resolution
Time from HoLEP to postoperative dysuria resolution
Measured: 90 days
Time from HoLEP to postoperative urgency resolution
Time from HoLEP to postoperative urgency resolution
Measured: 90 days
Enucleation/Operative time
Enucleation/Operative time
Measured: 24 hours
Total laser energy used
Total laser energy used
Measured: 24 hours
Perioperative change in hemoglobin
Perioperative change in hemoglobin
Measured: 6 months
Laser repair/maintenance rates
Laser repair/maintenance rates
Measured: 1 year
New postoperative urgency incontinence rates at 1month, 3months and 6months.
New postoperative urgency incontinence rates at 1month, 3months and 6months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study startDec 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: PI does not wish to move forward with the Study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Prostate DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Lumenis Be Ltd.
- Responsible party
- Principal investigator, Marcelino Rivera, Indiana University
- Investigators
- Marcelino Rivera, MD, Principal investigator, IU Health Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699552
- Sponsor's protocol ID
- 2010195334
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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. doi: 10.1016/s0022-5347(17)49698-4.
PubMed 6206240Gilling 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.
PubMed 9847070Tan 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.
PubMed 14501739Tan 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.
PubMed 17729384McVary 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.
PubMed 21420124Salonia 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.
PubMed 16904441Elhilali 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.
PubMed 28340540Large 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.
PubMed 31790785Houssin 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.
PubMed 32219512Kobayashi 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.
PubMed 27564285Hur 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.
PubMed 27847917Becker 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.
PubMed 29275506Elshal 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.
PubMed 30031005Stern 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.
PubMed 28017884Rivera 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.
PubMed 29774816
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT04699552
- Acronym / sponsor ID
- 2010195334
- Conditions
- Prostate Disease, Surgery
- Keywords
- Holmium Laser Enucleation, Prostate
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI does not wish to move forward with the Study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Lumenis Be Ltd.
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2J 20 Hz | Experimental | Device: 120W Lumenis Holmium:YAG laser 20JThe power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 20Hz |
| 2J 40 Hz | Experimental | Device: 120W Lumenis Holmium:YAG laser 40 JThe power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 40Hz |
| 2J 60 Hz | Experimental | Device: 120W Lumenis Holmium:YAG laser 60 JThe power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 60Hz |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
- Able to give informed consent.
- Age 18 years or older.
Key exclusion criteria (2 listed)
- Inability to give informed consent.
- Age less than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 120W Lumenis Holmium:YAG laser 20J120W Lumenis Holmium:YAG laser 20J | Device | 2J 20 Hz |
| 120W Lumenis Holmium:YAG laser 40 J120W Lumenis Holmium:YAG laser 40J | Device | 2J 40 Hz |
| 120W Lumenis Holmium:YAG laser 60 J120W Lumenis Holmium:YAG laser 60J | Device | 2J 60 Hz |
Primary outcome
Rate of patient reported postoperative UUI
Time frame: 1 month
Rate of patient reported postoperative UUI
8 secondary outcomes
AE reported via Clavien-Dindo classification
Time frame: 24 hours
Time from HoLEP to postoperative dysuria resolution
Time frame: 90 days
Time from HoLEP to postoperative urgency resolution
Time frame: 90 days
Enucleation/Operative time
Time frame: 24 hours
Total laser energy used
Time frame: 24 hours
Perioperative change in hemoglobin
Time frame: 6 months
Laser repair/maintenance rates
Time frame: 1 year
New postoperative urgency incontinence rates at 1month, 3months and 6months.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Background: PubMed 6206240Berry 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.
- Background: PubMed 9847070Gilling 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.
- Background: PubMed 14501739Tan 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.
- Background: PubMed 17729384Tan 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.
- Background: PubMed 21420124McVary 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.
- Background: PubMed 16904441Salonia 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.
- Background: PubMed 28340540Elhilali 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.
- Background: PubMed 31790785Large 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.
- Background: PubMed 32219512Houssin 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.
- Background: PubMed 27564285Kobayashi 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.
- Background: PubMed 27847917Hur 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.
- Background: PubMed 29275506Becker 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.
- Individual participant dataSharing planned: No
Related trials for Prostate Disease
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelino Rivera, MD principal investigator
IU Health Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 120W Lumenis Holmium:YAG laser 20J, 120W Lumenis Holmium:YAG laser 40 J and 120W Lumenis Holmium:YAG laser 60 J in people with Prostate Disease and Surgery, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patient reported postoperative UUI (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699552, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.