Ureteral Stent Size for Ureteral Stent Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the size of a ureteral stent (a small tube placed in the ureter to aid urine flow from the kidney to the bladder) affects pain and discomfort after surgery. The researchers will compare two stent sizes, 4.8 Fr and 7 Fr, to determine which size causes less discomfort. The trial targets individuals who have undergone kidney stone removal surgery and require a stent afterward. Those who have had this type of surgery and need a stent may be suitable candidates for the trial. As an unphased study, this trial provides a unique opportunity to contribute to medical knowledge and potentially enhance post-surgical comfort for future patients.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have found that smaller ureteral stents, like the 4.8 Fr, are more comfortable for patients, causing fewer symptoms than larger stents. Patients with these smaller stents reported less pain and discomfort in a survey about stent symptoms, suggesting that the 4.8 Fr stents might be gentler on the body.
In contrast, many patients with larger 7 Fr ureteral stents reported discomfort. Over 80% experienced pain that interfered with daily activities, and some faced issues like sexual problems and difficulty working. However, another study found that a different design of the 7 Fr stent was safe.
Overall, the 4.8 Fr stents appear more comfortable, with less pain reported. While the 7 Fr stents might cause more discomfort, some designs have been shown to be safe. Consulting a healthcare provider is important to determine the best option.12345Why are researchers excited about this trial?
Researchers are excited about the use of different ureteral stent sizes—4.8 Fr and 7 Fr—in addressing ureteral stent syndrome because they aim to find out which size offers better patient comfort and fewer side effects. Typically, standard treatments involve the use of ureteral stents to relieve obstructions, but the syndrome often causes discomfort and pain. By comparing these two sizes, researchers hope to determine if a smaller stent size can reduce symptoms while maintaining effectiveness, potentially improving the quality of life for patients.
What evidence suggests that this trial's treatments could be effective for ureteral stent syndrome?
Research has shown that smaller ureteral stents, such as the 4.8 Fr, often cause less pain and discomfort. In this trial, participants in Group A will receive the 4.8 Fr ureteral stents. Studies indicate that patients with these smaller stents report better results on the Ureteral Stent Symptom Questionnaire, experiencing fewer symptoms and a better quality of life compared to those with larger stents. Participants in Group B will receive the 7 Fr ureteral stents. Although 7 Fr stents are generally safe, they may not reduce symptoms as effectively as the smaller ones. Overall, evidence suggests that smaller stents might offer more comfort for patients experiencing ureteral stent syndrome.12367
Who Is on the Research Team?
Meghan A. Cooper, DO
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for individuals who have undergone a lithotripsy procedure, which is used to break up kidney stones. Participants must require a ureteral stent post-operation but cannot be part of the study if they meet certain exclusion criteria not specified here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ureteroscopy and receive either a 4.8 Fr or 7 Fr ureteral stent
Post-operative Monitoring
Participants are contacted daily to assess stent-related pain until stent removal
Follow-up
Participants are monitored for any additional post-operative issues and communication with the medical system
What Are the Treatments Tested in This Trial?
Interventions
- 4.8 Fr Ureteral stents
- 7 Fr Ureteral stents
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor