Urinary Tract Stone
Conditions
Keywords
Lithotripsy, Holmium laser
Brief summary
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.
Interventions
DEVICEHolmium laser with Moses lasers
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.
DEVICEHolmium laser with thulium lasers
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
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants will be randomized (ratio 1:1) at the time of enrollment to be treated with either the holmium laser with Moses or the thulium laser. Investigators will use Permuted Block Randomization (stratified by stone size 3 - 10 mm or 11-20 mm) (block size 4).
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Participants with renal or ureteral urinary stones who require endoscopic treatment in the outpatient operating room * Participant's stone size in a single renal unit of 3-10 mm and 11-20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT. Participants with multiple stones will be included as long as their largest stone size falls within the above parameters.
Exclusion criteria
* Participants under 18 years of age and over 89 years old. * Pregnant participants * Participants with transplant kidneys * Participants with irreversible coagulopathy * Participants with known ureteral stricture disease * Participants who do not have a pre-operative CT. * Non-English speaking, vulnerable participants such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Time (Minutes) | up to 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lasing Time (Minutes) | up to 6 hours | Time the laser was in use, not including pedal pauses |
| Total Energy Used (Kilojoules) | up to 6 hours | The total energy used to fragment the stones into small pieces (≤2 mm) |
| Ablation Efficiency (J/mm^3) | up to 6 hours | It is a ratio of ablated stone volume to the laser pulse energy (J/mm3) |
| Stone Free Rate | Baseline(pre-operative) and approximately 8 weeks | 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. |
| Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively | Baseline(pre-operative) and approximately 8 weeks (1 month post-operative) | 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. |
| Score on the Laser Evaluation Instrument | Up to 6 hours | 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. |
| Ablation Speed | 0-6 hours | The speed to fragment or dust stones |
| Number of Participants With Post-operative Complications | approximately 8 weeks (1 month post-operative) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Treated With Holmium Laser With the Moses Laser Holmium laser with Moses lasers: 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. | 52 |
| Participants Treated With Holmium Laser With the Thulium Laser Holmium laser with thulium lasers: 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 | 56 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | withdrew by the study team | 4 | 2 |
Baseline characteristics
| Characteristic | Participants Treated With Holmium Laser With the Moses Laser | Participants Treated With Holmium Laser With the Thulium Laser | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 20 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 36 Participants | 69 Participants |
| Age, Continuous | 61.1 years STANDARD_DEVIATION 12.8 | 59.6 years STANDARD_DEVIATION 11.3 | 60.3 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 56 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 55 Participants | 107 Participants |
| Sex: Female, Male Female | 21 Participants | 29 Participants | 50 Participants |
| Sex: Female, Male Male | 31 Participants | 27 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 56 |
| other Total, other adverse events | 5 / 52 | 6 / 56 |
| serious Total, serious adverse events | 0 / 52 | 0 / 56 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Procedural Time (Minutes) | 20 minutes |
| Participants Treated With Holmium Laser With the Thulium Laser | Procedural Time (Minutes) | 17 minutes |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Ablation Efficiency (J/mm^3) | 1.5 J/mm^3 |
| Participants Treated With Holmium Laser With the Thulium Laser | Ablation Efficiency (J/mm^3) | 1.8 J/mm^3 |
Secondary
Ablation Speed
The speed to fragment or dust stones
Time frame: 0-6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Ablation Speed | 482 mm^3 per minute |
| Participants Treated With Holmium Laser With the Thulium Laser | Ablation Speed | 413 mm^3 per minute |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively | 51.5 score on a scale | Standard Deviation 32.6 |
| Participants Treated With Holmium Laser With the Thulium Laser | Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively | 49 score on a scale | Standard Deviation 33.1 |
| Participants Treated With Holmium Laser With the Moses Laser Post Operative Score | Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively | 75.3 score on a scale | Standard Deviation 33.1 |
| Participants Treated With Holmium Laser With the Thulium Laser Post Operative Score | Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively | 84.3 score on a scale | Standard Deviation 19.1 |
Secondary
Lasing Time (Minutes)
Time the laser was in use, not including pedal pauses
Time frame: up to 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Lasing Time (Minutes) | 2.7 minutes |
| Participants Treated With Holmium Laser With the Thulium Laser | Lasing Time (Minutes) | 3.6 minutes |
Secondary
Number of Participants With Post-operative Complications
Time frame: approximately 8 weeks (1 month post-operative)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Number of Participants With Post-operative Complications | 5 Participants |
| Participants Treated With Holmium Laser With the Thulium Laser | Number of Participants With Post-operative Complications | 6 Participants |
Secondary
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
Population: Evaluation of the efficiency of the two lasers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Score on the Laser Evaluation Instrument | 4.3 score on a scale | Standard Deviation 0.5 |
| Participants Treated With Holmium Laser With the Thulium Laser | Score on the Laser Evaluation Instrument | 4.5 score on a scale | Standard Deviation 0.5 |
Secondary
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
Population: patients who did not have post operative image were not able to access stone free rate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Stone Free Rate | 40 Participants |
| Participants Treated With Holmium Laser With the Thulium Laser | Stone Free Rate | 40 Participants |
Secondary
Total Energy Used (Kilojoules)
The total energy used to fragment the stones into small pieces (≤2 mm)
Time frame: up to 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Treated With Holmium Laser With the Moses Laser | Total Energy Used (Kilojoules) | 1.2 KJ |
| Participants Treated With Holmium Laser With the Thulium Laser | Total Energy Used (Kilojoules) | 2.5 KJ |