Research

The objective of our multi-center randomized open-label study is to examine the safety and effect of intra-detrusor onabotulinumtoxinA injections at the time of holmium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence. 

 

Eligibility Criteria

Inclusion Criteria

• Males 18 -100 undergoing HoLEP who have had an inadequate response to anticholinergic medications

• Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence

• Willing to sign the Informed Consent Form

• Able to read, understand, and complete patient questionnaires.

 

Exclusion Criteria

• Allergy or hypersensitivity to OnabotulinumtoxinA injections

• Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP

• Anticipated need for perineal urethrostomy at the time of HoLEP Patients with prior pelvic radiation

• Patients with a history of bladder cancer with or without BCG therapy within the last 12 months

• Patients who lack decisional capacity

• Active urinary tract infection

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Principal Investigator

Krambeck, Amy Elizabeth

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ClinicalTrials.gov IdentifierNCT05878951

IRB numberSTU00218130

The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it will affect time in the operating room, time using the laser, laser energy, and stone free rates.

Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology.

 

The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

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Eligibility Criteria

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nclusion Criteria:

• Undergoing ureteroscopy and laser lithotripsy

• Stone size ≥8 but < 20 mm in the proximal ureter or kidney. Multiple stones ≤4 are allowed. Bilateral surgeries are allowed

• Willing to sign informed consent

 

Exclusion Criteria:

• Staged surgery

• Nephrocalcinosis

• Participant is less than 18 years of age

• Inability to provide informed consent

• Members of vulnerable patient populations

 

Principal Investigator

Krambeck, Amy Elizabeth

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ClinicalTrials.gov IdentifierNCT06346483

IRB numberSTU00218929