An interventional study of 120W Lumenis Holmium:YAG laser 20J and 120W Lumenis Holmium:YAG laser 40 J in Prostate Disease and Surgery, sponsored by Indiana University. Withdrawn at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by Indiana University · Not applicable, Interventional, and Other
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.
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.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 20J
120W Lumenis Holmium:YAG laser 40J
120W Lumenis Holmium:YAG laser 60J
Rate of patient reported postoperative UUI
Rate of patient reported postoperative UUI
Time frame: 1 month
AE reported via Clavien-Dindo classification
AE reported via Clavien-Dindo classification
Time frame: 24 hours
Time from HoLEP to postoperative dysuria resolution
Time from HoLEP to postoperative dysuria resolution
Time frame: 90 days
Time from HoLEP to postoperative urgency resolution
Time from HoLEP to postoperative urgency resolution
Time frame: 90 days
Enucleation/Operative time
Enucleation/Operative time
Time frame: 24 hours
Total laser energy used
Total laser energy used
Time frame: 24 hours
Perioperative change in hemoglobin
Perioperative change in hemoglobin
Time frame: 6 months
Laser repair/maintenance rates
Laser repair/maintenance rates
Time frame: 1 year
New postoperative urgency incontinence rates at 1month, 3months and 6months.
New postoperative urgency incontinence rates at 1month, 3months and 6months.
Time frame: 6 months
Plan to share: No
Start is estimated for Dec 2020; primary completion for Jul 2021, 7 months later.
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This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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