What side effects are associated with this type of intervention?

The most common treatment for kidney stones involving fluid intake intervention and behavioral modification primarily focuses on increasing water consumption to prevent stone formation. This approach generally has minimal side effects, but excessive fluid intake can lead to hyponatremia (low sodium levels) if not balanced properly. Other common treatments include the use of diuretics, which can reduce stone recurrence but may cause side effects such as dehydration, electrolyte imbalances, and increased urination. In some cases, medications like alpha-blockers are used to facilitate stone passage, which can cause dizziness, low blood pressure, and fatigue.

What prior FDA approvals exist?

FDA-approved treatments for kidney stones primarily include medications like potassium citrate, which helps prevent recurrent calcium stones. While specific FDA approvals for behavioral modifications are not detailed, increasing fluid intake is a widely recommended strategy to prevent stone formation. This approach aligns with the principles of the Fluid Intake Intervention study, emphasizing the importance of maintaining adequate hydration to reduce the risk of kidney stones.

What other types of research exist?

Promising novel alternatives to fluid intake intervention for kidney stone patients include: 1) Dietary modifications such as reducing dietary purine intake and increasing citrate-rich foods, 2) Pharmacological treatments like allopurinol for reducing uric acid levels, and 3) Minimally invasive surgical techniques such as ureteroscopy and laser lithotripsy. These alternatives have shown efficacy in clinical trials and are recommended in recent guidelines.

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Behavioral Intervention

sipIT for Kidney Stones

N/A

Recruiting

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Previous diagnosis of symptomatic kidney stone in the past 5 years

Must not have

Co-morbidities that preclude high fluid intake (congestive heart failure, end-stage renal disease, chronic hyponatremia)

Plan to have surgery in the next 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the end of the intervention period (3 months) to the maintenance change at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how a system that tracks fluid intake and sends reminders can help patients change and maintain their drinking habits, especially when their routines are disrupted by stress or life events.

Who is the study for?

This trial is for individuals who are currently experiencing kidney stones. The specific eligibility criteria to participate in the study have not been provided, so it's important to contact the research team for detailed information on who can join.

What is being tested?

The sipIT intervention is being tested in this study. It aims to understand how behavior changes, continues over time, and adherence are influenced during and after a three-month period of using sipIT.

What are the potential side effects?

Potential side effects of the sipIT intervention are not specified here. Participants interested should inquire with the research team about any risks or adverse reactions associated with this intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had a painful kidney stone in the last 5 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have heart failure, severe kidney disease, or chronic low sodium that would stop me from drinking a lot of fluids.

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I am planning to undergo surgery within the next 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the end of the intervention period (3 months) to the maintenance change at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the end of the intervention period (3 months) to the maintenance change at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the end of the intervention period (3 months) to the maintenance change at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urine volume (intervention)

Secondary study objectives

Urine volume (maintenance)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: sipITExperimental Treatment1 Intervention

Participants will receive an educational handout about physical activity, a connected water bottle with its companion mobile application. For months 1-3, participants will receive lapse-contingent reminders to drink delivered by text message.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for kidney stones include increased fluid intake, dietary modifications, and medications. Increased fluid intake helps dilute the substances in urine that lead to stones, reducing the risk of stone formation. Dietary modifications, such as reducing salt and animal protein intake, help decrease the concentration of stone-forming minerals. Medications like thiazide diuretics reduce calcium levels in urine, while citrate supplements can prevent stone formation by binding with calcium. These treatments are crucial for kidney stone patients as they address the root causes of stone formation, thereby preventing recurrence and reducing the need for surgical interventions.

Metabolic risk-evaluation and prevention of recurrence in stone disease: does it make sense?