Silicone (Coloplast Imajin Hydro) ureteral stent for Kidney Stones

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Henry Ford Hospital, Wyandotte, MI
Kidney Stones+5 More
Silicone (Coloplast Imajin Hydro) ureteral stent - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a silicone stent is better than a non-silicone stent.

See full description

Eligible Conditions

  • Kidney Stones
  • Ureteral Stones

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Silicone (Coloplast Imajin Hydro) ureteral stent will improve 2 primary outcomes and 7 secondary outcomes in patients with Kidney Stones. Measurement will happen over the course of up to 30 days.

Week 6
Change in NIH LURN SI-10 scores at 4 to 6 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 4 to 6 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 4 to 6 weeks
Day 10
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-intensity at 7 to 10 days
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) scores of pain-interference at 7 to 10 days
baseline, 7 to10 days
Change in National Institutes of Health (NIH) Lower Urinary Tract Dysfunction Research Network (LURN) Symptoms Index (SI)-10 scores at 7 to 10 days
up to 30 days
Composite healthcare utilization metric within 30 days
up to 60 days
Abnormal imaging findings within 60 days
Stone-free rates within 60 days

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).
1 of 2
Silicone (Coloplast Imajin Hydro) ureteral stent
1 of 2
Experimental Treatment

This trial requires 224 total participants across 2 different treatment groups

This trial involves 2 different treatments. Silicone (Coloplast Imajin Hydro) Ureteral Stent is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer).
Device
Silicone (Coloplast Imajin Hydro) ureteral stent
Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 to 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 4 to 6 weeks for reporting.

Who is running the study

Principal Investigator
K. G.
Prof. Khurshid Ghani, Associate Professor of Urology
University of Michigan

Closest Location

Henry Ford Hospital - Wyandotte, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
of the abdomen The person has a kidney or ureter stone that is less than or equal to 2.0 cm on an abdominal x-ray, ultrasound, or computerized tomography scan. show original
A ureteral stone is a stone that is located in the ureter show original
Ability to swallow medication. show original
The ability and willingness to complete and adhere to survey questions and responses throughout the study duration is necessary. show original
A renal stone is a stone that is located in the kidneys. show original
I am willing to comply with all study procedures and am available for the duration of the study. show original
A planned unilateral ureteroscopy will be performed with a stent placed without a stent string. show original

Patient Q&A Section

Does silicone (coloplast imajin hydro) ureteral stent improve quality of life for those with ureteral calculi?

"We found stent-based treatment significantly improved the patient's QOL in urinary symptoms. Results from a recent paper suggest that stent implantation may have the same favorable effect on urinary symptoms as open ureteral stenting is." - Anonymous Online Contributor

Unverified Answer

What is ureteral calculi?

"Ureteral calculi are formed in the kidneys during the time when a child is starting to urinate. As a child is learning to hold urine by themselves it is important that the ureters are clear. If the patient has a kidney stone then there is a very high chance that they will have two stones. Any pain would be caused by passing the stones out. If pain persists then a doctor should be contacted. Stones are not always dangerous. In those with small stones that are not causing any pain, some people with stones may be able to keep a small stone in their bladder. If they want to take back the stone it doesn’t have to be painless." - Anonymous Online Contributor

Unverified Answer

What causes ureteral calculi?

"It is likely that a ureteral stone is precipitated by a physiological malfunction, i.e. abnormally formed proteins that are difficult to eliminate, or abnormal metabolic processes that produce excess salts." - Anonymous Online Contributor

Unverified Answer

What are the signs of ureteral calculi?

"The most frequently encountered sign of ureteral calculi is pain; however, these are often nonspecific. Other commonly reported signs include decreased appetite, blood in the urine, nausea, and fever. Painless ureteral calculi may present with other clinical signs. Urinary frequency and straining often are the first signs of ureteral calculi. They are followed by frequency of urination of > 2 h before waking, a sudden decrease in urine volumes after waking, and/or a volume of <100 mL per voiding. A flank mass may be palpable, or the presence of pyuria may be appreciated." - Anonymous Online Contributor

Unverified Answer

What are common treatments for ureteral calculi?

"For most patients, nonsurgical approaches are normally used. A combination of antibiotics and urine prophylactic measures are effective in prevention of urinary tract infections due to the large incidence of stasis." - Anonymous Online Contributor

Unverified Answer

How many people get ureteral calculi a year in the United States?

"Between 1990 and 1995, the number of patients who had a stone for more than 1 year of the study period fell by 50% in the USA. We believe this represents a significant reduction in the number of patients getting ureteral calculi annually in the USA." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving silicone (coloplast imajin hydro) ureteral stent?

"Based on the information obtained, it was found that it was a safe procedure with no complications. We believe that, in cases with chronic obstruction of the ureter, the use of this biomaterial is a suitable alternative for conservative or surgical treatments." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of silicone (coloplast imajin hydro) ureteral stent?

"In the case of ureteral stent due to ureteral obstruction, the side effects of silicone stent is a major issue when compared to other kinds of ureteral stent; however, its side effects in the case of nephrostomy is not a major issue. Silicone stent in nephrostomy tube is a good choice in case of ureteral obstruction due to malignancy or kidney transplantation." - Anonymous Online Contributor

Unverified Answer

How does silicone (coloplast imajin hydro) ureteral stent work?

"Coloplast Imajin stent was used in our case series for treatment of ureteral obstruction. Coloplast Imajin has good efficacy in treatment of ureteral obstruction. Nevertheless, caution is needed since its efficacy in patients with urologic malformation should be assessed because silicone can be found in the urinary system of patients." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets ureteral calculi?

"Age is one of the major factors of ureteral calculi formation. The higher the year of birth, the higher the risk of having calculus ureter." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for ureteral calculi?

"Nephrolithiasis is a common problem that is common to all races and socioeconomic levels. Considering the risk of complications and costs of surgery, patients may want to have an alternative treatment regimen that reduces the size of the stones and decreases the possibility of recurrence. Using clinical trials to determine the most preferred treatment regimen, is the first and most important step in determining the best approach to ureteral calculi." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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