sipIT Intervention for Kidney Stones

Recruiting at 1 trial location

Overseen By Alyssa Cutshaw, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Must not be taking: Lithium

Disqualifiers: Pregnancy, Congestive heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

216 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the feasibility of using sipIT tools (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase compliance with physician-recommended fluid consumption guidelines in participants with a history of urolithiasis.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic lithium treatment, you cannot participate in the study.

Is the sipIT treatment generally safe for humans?

The research articles provided do not contain specific safety data for the sipIT treatment or any treatment evaluated under different names for various conditions. ^{1 2 3 4 5}

How does the sipIT treatment for kidney stones differ from other treatments?

The sipIT treatment for kidney stones is unique because it focuses on a patient-centered approach that combines nutritional and medical therapy, guided by 24-hour urinary stone risk, which is different from standard treatments like potassium citrate or herbal remedies that primarily target stone prevention or dissolution. ^{6 7 8 9 10}

Research Team

David E Conroy, PhD

Principal Investigator

The Pennsylvania State University

Necole M Streeper, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for English-speaking adults over 18 who've had a kidney stone in the last 5 years, can use a smartphone, and are willing to wear a Fitbit daily for a year. They should drink less than 2 liters of fluid per day. It's not for pregnant women or those planning pregnancy, people moving away or having surgery soon, on certain medical treatments, with specific health conditions that affect fluid intake or urine collection.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

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

Own iOS or Android smartphone

Exclusion Criteria

Pregnant or planning to become pregnant in the next 12 months

I have been diagnosed with cystine kidney stones before.

Concurrently participating in another study involving fluid intake or diet

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants' fluid intake and urine volume

1 visit

Intervention

Participants receive education and, if in the experimental group, a digital tool to monitor fluid intake

12 months

Visits at 1, 3, and 12 months

Follow-up

Participants are monitored for changes in urine volume and fluid intake habits

12 months

Outcome assessments at 1, 3, and 12 months

Treatment Details

Interventions

• sipIT

Trial Overview The sipIT study tests if tools like wrist sensors, smart water bottles, and apps can help people with past kidney stones follow doctor's advice on drinking enough fluids. Participants will use these tech aids to see if they improve their hydration habits.

Participant Groups

Group I: sipIT Experimental Treatment 1 Intervention

Participants receive education and a digital tool to monitor their fluid intake and remind them when they have lapsed in regular fluid intake.

Group II: Control Active Control 1 Intervention

Participants receive usual care (i.e., education about fluid intake guidelines and encouragement to meet those guidelines).

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Findings from Research

In a study of 242 patients with calcium-containing kidney stones, those who received specific dietary therapy tailored to their metabolic needs had a significantly lower recurrence rate of stones (6%) compared to those who followed general dietary advice (19%).

The results suggest that personalized dietary counseling is crucial for preventing future kidney stones, highlighting the importance of tailored interventions over generic recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of nonmedical prophylaxis after a first kidney stone. Kocvara, R., Plasgura, P., Petrík, A., et al.[2019]

A combined nutritional and medical therapy approach significantly improved urinary risk factors for stone disease in 137 patients over an average follow-up of 14.39 months, with notable improvements in hypocitraturia (67% of patients), hypercalciuria (82%), and hyperuricosuria (72%).

The study highlights that individualized medical management based on specific urinary abnormalities can effectively reduce stone risk, especially for patients who do not respond to dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered medical therapy for nephrolithiasis. Marchini, GS., Ortiz-Alvarado, O., Miyaoka, R., et al.[2013]

Potassium citrate therapy significantly reduced new stone formation in patients with mild to moderately severe stone disease, achieving a remission rate of 96% (from 0.52 to 0.02 stones per patient per year, p < 0.001).

In contrast, conservative measures or placebo trials only decreased new stone formation by 54% (from 0.54 to 0.25 stones per patient per year), indicating that potassium citrate provides a more effective treatment beyond standard conservative approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of "specific" potassium citrate therapy versus conservative management in nephrolithiasis of mild to moderate severity. Preminger, GM., Harvey, JA., Pak, CY.[2019]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

The role of Aescin versus Prednisolone in the management of symptomatic lower ureteral calculi: A comparative study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Ningmitai capsule promotes calculi expulsion after RIRS for 10-20-mm upper urinary stones: a multicenter, prospective, randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A prospective study of nonmedical prophylaxis after a first kidney stone. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Urinary supersaturation in a Randomized trial among Individuals with Nephrolithiasis comparing Empiric versus selective therapy (URINE): design and rationale of a clinical trial. [2023]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Acute kidney injury in Ureteric Stones:Single centre short term analysis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-centered medical therapy for nephrolithiasis. [2013]

7. Germany pubmed.ncbi.nlm.nih.gov

Effect of Cystone® on urinary composition and stone formation over a one year period. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of potassium citrate therapy on stone recurrence and residual fragments after shockwave lithotripsy in lower caliceal calcium oxalate urolithiasis: a randomized controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of "specific" potassium citrate therapy versus conservative management in nephrolithiasis of mild to moderate severity. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Medical therapy for calculus disease. [2014]