The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United States are affected by renal stone disease. This has led to an increased demand on Urologists for efficient and safe surgical treatment of stone disease. Over the past two decades, ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and renal stones globally. The holmium laser is considered the gold standard for laser lithotripsy. Holmium laser lithotripsy with Moses and the thulium laser are new technologies meant to improve the efficiency of laser lithotripsy. Both are FDA approved treatment modalities for stone disease. Two in vitro studies have compared Moses versus thulium and shown that thulium has higher ablative volumes then the holmium laser with Moses, but no clinical trials have compared the two treatment modalities. In this study, investigators are going to conduct a prospective, randomized clinical trial to determine whether there is a difference in procedural time, intraoperative parameters or stone free rate between the Holmium laser with Moses and the thulium laser. This is significant as this may lead to shorter overall operative times, which may result in decreased operative costs and complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
The holmium laser with Moses is FDA approved. It emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. The goal is to increase stone ablative volume and decrease retropulsion of the stone.
The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns
University of Wisconsin
Madison, Wisconsin, United States
Procedural Time (Minutes)
Time from the minute the ureteroscope is inserted into the participant to the time the ureteroscope has been removed will be reported as procedural time.
Time frame: up to 6 hours
Stone Free Rate
Stone free rate (SFR) (%) are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the urinary tract which were defined as ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.
Time frame: Baseline(pre-operative) and approximately 8 weeks
Lasing Time (Minutes)
Time the laser was in use, not including pedal pauses
Time frame: up to 6 hours
Total Energy Used (Kilojoules)
The total energy used to fragment the stones into small pieces (≤2 mm)
Time frame: up to 6 hours
Ablation Efficiency (J/mm^3)
It is a ratio of ablated stone volume to the laser pulse energy (J/mm3)
Time frame: up to 6 hours
Number of Participants With Post-operative Complications
Time frame: approximately 8 weeks (1 month post-operative)
Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively
WISQOL short form is a 6 item questionnaire which can be scored from 1(worst outcome) to 5 (best outcome). The raw score range is 5-30. In the study, standardized total score is used. the range of the standardized total score is 0-100.
Time frame: Baseline(pre-operative) and approximately 8 weeks (1 month post-operative)
Score on the Laser Evaluation Instrument
Physician evaluation of the laser will be done by Laser Evaluation Instrument. It consists of 6 items which can be scored from 0(worst outcome) to 5 (best outcome). Cumulative score may range from 0-30.
Time frame: Up to 6 hours
Ablation Speed
The speed to fragment or dust stones
Time frame: 0-6 hours
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