retrograde nephrostomy for Kidney Stones

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Kidney Stones+1 More
retrograde nephrostomy - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a particular approach to percutaneous nephrostomy is better than another.

See full description

Eligible Conditions

  • Kidney Stones

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Kidney Stones

Study Objectives

This trial is evaluating whether retrograde nephrostomy will improve 11 primary outcomes and 5 secondary outcomes in patients with Kidney Stones. Measurement will happen over the course of (end of procedure)about 3 hours after start of procedure.

Hour 3
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy
24 hours after procedure
Number of patients with normal laboratory values
Treatment efficacy as measured by length of post-operative hospital stay
6-12 weeks after procedure
Number of patients that are stone free
Number of patients that require pain medication (defined as discharge with an opioid prescription).
Number of patients with an infection rate which is defined as a positive culture within the study time period
Number of patients with symptom free survival as defined as lack of flank pain
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.
Number of patients with symptom free survival as defined as lack of limitations to work
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms
Week 8
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access
end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of access operation fluoroscopy
Treatment efficacy as measured by total time of access operation.
Hour 3
Number of patients with nephrostomy access adequate for stone treatment
Number of patients with normal vital signs
Hour 3
Treatment efficacy as measured by total time of lithotomy operation

Trial Safety

Safety Progress

1 of 3

Other trials for Kidney Stones

Trial Design

2 Treatment Groups

Control Group ( antegrade nephrostomy)
1 of 2
Treatment (retrograde nephrostomy)
1 of 2
Active Control
Experimental Treatment

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Retrograde Nephrostomy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment (retrograde nephrostomy)
Device
Control Group ( antegrade nephrostomy)
Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: end of procedure( about 90 minutes after start of procedure)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly end of procedure( about 90 minutes after start of procedure) for reporting.

Who is running the study

Principal Investigator
N. N. D.
Prof. Nadeem N Dhanani, Assistant Professor
The University of Texas Health Science Center, Houston

Closest Location

The University of Texas Health Science Center at Houston - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
-Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography

Patient Q&A Section

What is kidney calculi?

"Kidney calculi is an obstruction of the renal pelvis and calyx due to crystalline deposition of calcium-based oxalate and struvite on the outer or central area of the kidney. They arise due to a combination of genetic, dietary, lifestyle or other factors and can take different forms of presentation in relation to the age of the patient. Symptoms include renal colic due to the calculus obstruction and can also lead to renal function deterioration due to calcium oxalate urolithiasis, which is often mistaken for stone disease." - Anonymous Online Contributor

Unverified Answer

What causes kidney calculi?

"Kidney stones are a common problem worldwide. The urinary tract obstruction due to stones can cause kidney damage, but most of time is related to infection." - Anonymous Online Contributor

Unverified Answer

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

"In the United States, kidney diseases account for about 2% of all hospitalizations. Nephrocalcinosis patients accounted for about 7% of all patients admitted to U.S. hospitals with a diagnosis of chronic kidney disease or chronic kidney disease without a known cause. On average about 38,000 persons were hospitalized with nephrocalcinosis annually." - Anonymous Online Contributor

Unverified Answer

What are common treatments for kidney calculi?

"The two most common treatments that have been observed in the clinical literature are non-operative (surgical) and surgical. Both of these approaches are highly successful in selected patients, and most kidney stone patients will eventually require treatment. However, many patients with symptomatic kidney stone disease will be left with long-term morbidity, which is a major public health issue." - Anonymous Online Contributor

Unverified Answer

Can kidney calculi be cured?

"There are many reasons why patients in a nephrology center may be willing to tolerate and undergo a course of ESWL to achieve complete stone-free status. Nevertheless, ESWL is frequently a one-shot solution to complete stone-free status. When ESWL does not provide a complete solution, a course of ESWL plus a one-time treatment of a second stone to completely clear out the kidney stones is often effective at achieving stone-free status. Some patients may benefit from another ESWL course after stones have completely cleared out." - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney calculi?

"The signs that should prompt a person with kidney stones to seek medical advice include flank pain, fever and increased frequency of urination. The signs that should prompt a doctor to make a referral include stone frequency or stone size. There is an increasing incidence of kidney stones in western Sydney and the greater north shore region. Most people have several stones over time. The mean duration of kidney stone-related symptoms is 6.7 years with the mean number of symptomatic stones being 3." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for kidney calculi?

"These data suggest that patients who have either symptomatic kidney disease (creatinine > 1.2 mg/ml) or serum creatinine > 1.7 mg/ml should consider enrolling themselves into clinical trials." - Anonymous Online Contributor

Unverified Answer

Is retrograde nephrostomy typically used in combination with any other treatments?

"Retrograde nephrostomy has been shown to be a simple, effective and minimally invasive procedure for nephrolith removal in patients with solitary stones, simple or mixed renal calculi. However, its use in combination with other treatment modalities have not been evaluated. Thus, future randomized controlled study is needed to assess the effectiveness and safety of retrograde nephrostomy in combination with other treatment modalities such as shockwave lithotripsy." - Anonymous Online Contributor

Unverified Answer

What is the latest research for kidney calculi?

"The latest researches have revealed the significance of noninvasive techniques, such as X-ray computed tomography, magnetic resonance tomography, and ultrasonography, to diagnose kidney stones and evaluate the risk. These methods have significantly reduced the need for surgery and it is a convenient treatment method by minimizing cost and complication for the entire population." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating kidney calculi?

"While there are no new therapies for treating kidney calculi that can potentially be found in the next 12 months, there could be further research on existing therapies. For now, we know that there are several options for preventing, treating, or even curing kidney calculi. Further research must be conducted on the prevention and treatment of kidney calculi with [chemotherapy, calcium channel blockers, and calcium channel antagonists] and [drugs to prevent or treats the cardiovascular disease]." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving retrograde nephrostomy?

"This is the first such report. It confirms that retrograde nephrostomy is easy to perform and can be regarded as an effective treatment during ureteric calculi surgery and can be considered as a good alternative to surgery." - Anonymous Online Contributor

Unverified Answer

How does retrograde nephrostomy work?

"Retrograde nephrostomy is not just simple drainage of accumulated urine and has its own advantages and disadvantages. The choice of the technique needs to be tailored to the individual patient based on the experience and the resources at the patients’ disposal." - 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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