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| ID | Type | Description | Link |
|---|---|---|---|
| A539800 | Other Identifier | UW Madison | |
| SMPH/UROLOGY/UROLOGY | Other Identifier | UW Madison | |
| Protocol ver 11-29-2021 | Other Identifier | HS-IRB UW Madison |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with Holmium laser with the Moses laser | Experimental |
| |
| Participants treated with Holmium laser with the thulium laser | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holmium laser with Moses lasers | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline(pre-operative) and approximately 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Nakada, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients withdrew were not included in the following data collection and analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | minutes | up to 6 hours |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstructing fragments required surgical treatment | Renal and urinary disorders | Non-systematic Assessment | Patients had obstructing fragments which required unplanned surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shuang Li | University of Wisconsin School of Medicine and Public Health | 608.263.8336 | lis@urology.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2021 | May 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2021 | May 11, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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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).
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|
| Holmium laser with thulium lasers | Device | 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 |
|
| Lasing Time (Minutes) | Time the laser was in use, not including pedal pauses | up to 6 hours |
| Total Energy Used (Kilojoules) | The total energy used to fragment the stones into small pieces (≤2 mm) | up to 6 hours |
| Ablation Efficiency (J/mm^3) | It is a ratio of ablated stone volume to the laser pulse energy (J/mm3) | up to 6 hours |
| Number of Participants With Post-operative Complications | 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. | 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. | Up to 6 hours |
| Ablation Speed | The speed to fragment or dust stones | 0-6 hours |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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
|
|
| 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. | patients who did not have post operative image were not able to access stone free rate | Posted | Count of Participants | Participants | Baseline(pre-operative) and approximately 8 weeks |
|
|
|
| Secondary | Lasing Time (Minutes) | Time the laser was in use, not including pedal pauses | Posted | Median | Full Range | minutes | up to 6 hours |
|
|
|
| Secondary | Total Energy Used (Kilojoules) | The total energy used to fragment the stones into small pieces (≤2 mm) | Posted | Median | Full Range | KJ | up to 6 hours |
|
|
|
| Secondary | Ablation Efficiency (J/mm^3) | It is a ratio of ablated stone volume to the laser pulse energy (J/mm3) | Posted | Median | Full Range | J/mm^3 | up to 6 hours |
|
|
|
| Secondary | Number of Participants With Post-operative Complications | Posted | Count of Participants | Participants | approximately 8 weeks (1 month post-operative) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline(pre-operative) and approximately 8 weeks (1 month post-operative) |
|
|
|
| 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. | Evaluation of the efficiency of the two lasers | Posted | Mean | Standard Deviation | score on a scale | Up to 6 hours |
|
|
|
| Secondary | Ablation Speed | The speed to fragment or dust stones | Posted | Median | Full Range | mm^3 per minute | 0-6 hours |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 5 |
| 52 |
| EG001 | 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 | 0 | 56 | 0 | 56 | 6 | 56 |
|
| Obstructing fragments passed | Renal and urinary disorders | Non-systematic Assessment | Obstructing fragments passed successfully |
|
| ER visit and discharge | Renal and urinary disorders | Non-systematic Assessment | Patient ER visit within the follow up period |
|
| UTI treated with outpatient antibiotics | Renal and urinary disorders | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |