Renal Stone
Conditions
Brief summary
This is a prospective randomized controlled trial designed to assess the efficacy and safety of Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser (thulium fiber laser), in dusting of renal stones during ureteroscopy with laser lithotripsy. 310 participants will be enrolled across 5 research sites.
Detailed description
This study will be a randomized clinical trial comparing ureteroscopy with laser lithotripsy with the Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser technology (thulium fiber laser). The primary objective is to compare the stone free rate as determined by computed tomography (CT) scan at two months (6-10 weeks) post operatively. A single urologist will evaluate all CT scans for residual stones and will be blinded to which laser was used during ureteroscopy. The following information will be collected for research purposes as secondary outcomes: (1) stone treatment time (time from the start of lasing to the end of lasing; minutes); (2) total operative time (minutes); (3) lasing time (minutes, time the laser was in use, not including pedal pauses); (4) total energy used (kilojoules, kJ); (5) laser efficiency (mm per minute); (6) number of times the laser pedals are pressed (left, right, and total pedal presses); (7) laser fiber size; (8) stone analysis; (9) complications, and (10) patients' quality of life. The results from the pre- and post-operative quality of life survey (WISQOL short form) will be obtained from the patient's medical record. A total of 3 clinic visits (i.e., the pre-operative visit and the stone surgery, one post-operative visit after 2 months of the surgery) will be needed for this study. All visits are standard of care. Stone parameters (i.e. size, location, Hounsfield units, presence of hydronephrosis, stone volume, and composition), demographic information, co-morbidities, and post-operative parameters will be collected from the medical record in HealthLink. The Thulium laser company is not involved in this research.
Interventions
DEVICEHolmium laser with pulse modulation
The holmium laser with pulse modulation 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.
DEVICEThulium fiber laser
The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A single urologist will evaluate all CT scans for residual stones and will be blinded to which laser was used during ureteroscopy.
Intervention model description
Participants will be randomized (ratio 1:1) to be treated with either the holmium laser with pulse modulation or the thulium fiber laser. Each site will randomize their own participants. Block randomization in block sizes of 4 will be used to assign participants to each laser treatment group. If unable to use the specified laser for any reason, the participant will be considered a withdrawal
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients with renal stones who require endoscopic laser treatment in the outpatient operating room. Patients may have an ureteropelvic junction (UPJ) stone if the treatment of the stone is completed in the kidney. * Patients' stone size in a single renal unit of greater than or equal to 5 millimeters (mm) and less than or equal to 20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT as assessed by the urologist. Patients with multiple stones will be included as long as their largest stone size falls within the above parameters.
Exclusion criteria
* Pregnant patients * Patients with transplant kidneys or other anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture * Patients with irreversible coagulopathy * Patients with known ureteral stricture disease * Patient who do not have a pre-operative CT * Non-English speaking patients and patients in other vulnerable groups such as lacking of decision-making capability, prisoner, or adult unable to consent * Uric acid composition greater than 50 percent on pre operative stone analysis. Patients will be excluded post operatively if stone analysis from the time of surgery is greater than 50 percent uric acid. * Prior ureteroscopy within 6 weeks of current surgery * Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope * Patients with only ureteral stones (ureteropelvic junction stones may be included as long as treated in the kidney) * Patients with renal tubular acidosis or medullary sponge kidney
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Free Rate | Post-operative (up to 10 weeks) | The primary objective of this study is to compare the stone free rate as determined by ultra-low dose limited renal CT at 2 months post operatively between the holmium laser with pulse modulation and the thulium fiber laser. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone Treatment Time in Minutes | day of procedure (up to 3 hours) | Time from the start of lasing to the end of lasing. |
| Procedural Time | day of procedure (up to 3 hours) | Time from the insert to removal of the instrument. |
| Total Energy Used in Kilojoules | day of procedure (up to 3 hours) | The total energy used for the stone surgery is documented by the laser machine. With reported case averages ranging from 0.1 to 42.1 kJ depending on stone size and technique (e.g., dusting vs. fragmentation).This parameter is a measure of the efficiency of stone treatment. |
| Number of Participants With Complications | day of procedure (up to 10 weeks) | All complications are documented during the procedure and the total follow-up time (up to 10 weeks). This outcome measure include the procedural complications and post-operative complications. |
| Participant Quality of Life as Measured by the WISQOL Short Form Score Pre-procedure Assessment | before the procedure (up to 3 hours before procedures) | 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 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes. |
| Participant Quality of Life as Measured by the WISQOL Short Form Score Post-procedure Assessment | Post-operative (up to 10 weeks) | 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 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephen Nakada, MD, FACS, FRCS
University of Wisconsin, Madison
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 170 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 164 Participants |
| Region of Enrollment United States | 178 participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 89 |
| other Total, other adverse events | 0 / 89 | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 | 0 / 89 |
Outcome results
None listed