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| ID | Type | Description | Link |
|---|---|---|---|
| Urology | Other Identifier | UW Madison | |
| Protocol Version 10/28/2024 | Other Identifier | UW Madison |
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This is a prospective randomized controlled trial designed to assess the differences in postoperative symptoms related to placement of a 6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents, 4.8Fr Percuflex ureteral stents, and 4.8Fr Tria ureteral stents after ureteroscopy with laser lithotripsy for treatment of upper tract urinary stones. 272 participants will be enrolled and will be on study for up to approximately 10 weeks.
The investigators will compare Ureteral Stent Symptom Questionnaire (USSQ) scores with each ureteral stent. Laser lithotripsy is a surgical procedure performed during stone surgeries. The Percuflex ureteral stent and Tria ureteral stent are FDA approved and clinically used in the United States.
A total of 3 clinic visits (i.e., pre-operative visit, the stent removal 1-2 weeks after surgery, and one post-operative visit 3-6 weeks after surgery) in addition to the surgery will be needed for this study. The patient's demographic information and medical background data will be collected from the medical record.
The USSQ will be administered twice:
The following information will be collected as secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6Fr Percuflex ureteral stents | Active Comparator |
| |
| 6Fr Tria ureteral stents | Active Comparator |
| |
| 4.8Fr Tria ureteral stents | Active Comparator |
| |
| 4.8Fr Percuflex ureteral stents | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6Fr Percuflex ureteral stents | Device | The Percuflex stent is a 6Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The urinary subscale score range from 11-54. | at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain Index | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-37. | at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The General Health subscale score range from 6-28. | at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Work Performance subscale score range from 3-15. | at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual matters |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life measured by WISQOL Scores | 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. | pre-operative visit (baseline), the stent removal 1-2 weeks after surgery (up to 4 weeks on study), and one post-operative visit 3-6 weeks after surgery (up to 10 weeks on study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuang Li | Contact | 608.263.8336 | lis@urology.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ali Antar, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53792 | United States |
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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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| 6Fr Tria ureteral stents | Device | The Tria stent is a new stent that is designed to soften at body temperature after placement, with an additional coating that prevents calcium and magnesium build up. This is intended to increase patient tolerability of the stent. 6 Fr is the diameter. |
|
| 4.8Fr Tria ureteral stents | Device | The Tria stent is a new stent that is designed to soften at body temperature after placement, with an additional coating that prevents calcium and magnesium build up. This is intended to increase patient tolerability of the stent. 4.8 Fr is the diameter. |
|
| 4.8Fr Percuflex ureteral stents | Device | The Percuflex stent is a 4.8Fr polymeric, hydrophilic coated stent that is routinely used post ureteroscopy with laser lithotripsy. |
|
USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Sexual Matters subscale score range from 2-10.
| at time of stent removal 1-2 weeks after surgery (up to 4 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-Urinary symptoms | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The urinary subscale score range from 11-54. | at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-Pain index | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-37. | at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-General Health | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Pain subscale score range from 6-28. | at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-Work Performance | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Work Performance subscale score range from 3-15. | at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) |
| Ureteral Stent Symptom Questionnaire (USSQ) scores-Sexual Matters | USSQ is a 38-item questionnaire to evaluate symptoms and impact on quality of life of ureteral stents. The high scores indicate worse outcomes. It has 5 sections, urinary symptoms, pain, general health, work performance, and sexual matters. The Sexual Matters subscale score range from 2-10. | at time of stent removal 3-6 weeks after surgery (up to 10 weeks on study) |
| Number of Emergency Room Visits | Data collected from medical record. | up to 10 weeks |
| Number of Unscheduled Clinic Follow-Ups | Data collected from medical record. | up to 10 weeks |
| Summary of Additional Prescriptions for Stent-Related Symptoms | Data collected from medical record. | up to 10 weeks |
| Summary of Stent Complications | up to 10 weeks |
| Physician Evaluation of Stent: Survey Scores | Physicians will complete a one page survey at the end of the case evaluating the stent. Scores are from 0-5 where higher scores indicate a more positive evaluation. | up to 10 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |