UrolithiasisNCT05329389
Adherence to Fluid Intake Recommendations in Kidney Stone Patients
A study testing StoneMD, Schools of Patients and Standard recommendation in people with Urolithiasis, run by Gadzhiev Nariman at 1 site in Russia.
Trial summary
The cumulative risk of stone recurrence rate is up to 14% at 1 year, 35% at 5 years, and 52% at 10 years. Low urine volume caused by insufficient fluid consumption is one of the most crucial risk factors for kidney stone formation. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- StoneMD, Schools of Patients and Standard recommendation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Low risk recurrence group patients;
- Patients after the first stone surgery;
Who cannot join
- Recurrent cases of stone formation;
- Patients, who do not have smartphones;
- Patients, who can't visit "Schools for Patients" with kidney stone disease;
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
SBPSU
Saint Petersburg, 190005
Vitalii Gelig
About this study
Official title: Adherence to Fluid Intake Recommendations After Stone Removal in Low Risk Group Patients
The cumulative risk of stone recurrence rate is up to 14% at 1 year, 35% at 5 years, and 52% at 10 years. Low urine volume caused by insufficient fluid consumption is one of the most crucial risk factors for kidney stone formation. According to the guidelines, a copious fluid intake to maintain a urine volume of at least 2.0 to 2.5 L/24 h is recommended for most kidney stone formers. Patients often find it difficult to follow the recommendations in fluid intake, which leads to stone recurrence. Therefore, there is a need to improve patient compliance and adherence to following the instructions on keeping water balance. For this purpose we developed a mixed educational program including two parts. The first is the mobile application called "StoneMD: Kidney Stones". The second is the "School for Patients" with kidney stones, which is responsible for the stone clinic effect.
Read the detailed description
The aim of the study is to test the hypothesis that using mixed educational program additionally to standard recommendations in patients after the first stone surgery episode helps to achieve better adherence to daily fluid intake recommendations than the using standard recommendations alone given at the day of discharge.
- Conditions
- Urolithiasis
- Being tested
- StoneMD, Schools of Patients, Standard recommendation
- Keywords
- application, StoneMD, Schools of patients
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StoneMDDevice
StoneMD - is an app from App Store (for iOS) or Google Play (for Android).
Schools of PatientsBehavioural
The "Schools for Patients" with Urolithiasis is an online course for patients with urinary stone disease.
Standard recommendationBehavioural
Only fluid balance recommendations given at the day of discharge.
| Study group | Role | What they receive |
|---|---|---|
| StoneMD | Experimental | Patients will receive standard recommendations of keeping diuresis at the level of 2.5 l/day and to use the StoneMD application on their smartphones after the surgery. Patients will use the section "Water balance" and follow the instructions during the 12 month after the surgery. Receives: Device: StoneMD; Behavioral: Standard recommendation |
| StoneMD & Schools of Patients | Experimental | Patients will receive standard recommendations of keeping diuresis at the level of 2.5 l/day and and recommendations to use the StoneMD application on their smartphones after the surgery. Patients will use the section "Water balance" and follow the instructions during the 12 month after the surgery. Additionally, patients will visit schools during a following year. Patients receive 4 consultations (one per 3 month). Receives: Device: StoneMD; Behavioral: Schools of Patients; Behavioral: Standard recommendation |
| Recommendations only | Active comparator | Only fluid balance recommendations given at the day of discharge. Patients will receive recommendations of keeping diuresis at the level of 2.5 l/day after the surgery Receives: Behavioral: Standard recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of daily urine
The primary outcome will be measured in the lab in international units of measurement
Measured: 12 month after the surgery
Concentration of creatinine in daily urine
The primary outcome will be measured in the lab in international units of measurement
Measured: 12 month after the surgery
Secondary outcomes (1)
Likert scale questionnaire scores
Likert scale questionnaire of the usefulness of the app "StoneMD" and "Schools for patients". Higher scores means a better outcome.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Jan 2023
- Primary completion4 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In case of presence/absence of inclusion/exclusion criteria and written informed consent will be obtained, patients will be randomized in a 1:1:1 ratio according to the list of randomized blocks using a computer generator. Patients will be randomized at the last available moment in order to minimize bias.
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadzhiev Nariman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gadzhiev Nariman, Saint Petersburg State University, Russia
- Investigators
- Nariman Gadzhiev, PhD, Principal investigator, Deputy Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329389
- Sponsor's protocol ID
- StoneMD_Schools_for_patients
- Status last verified
- May 2023
- First submitted
- 29 Mar 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
PubMed 2688503Siener R, Hesse A. Fluid intake and epidemiology of urolithiasis. Eur J Clin Nutr. 2003 Dec;57 Suppl 2:S47-51. doi: 10.1038/sj.ejcn.1601901.
PubMed 14681713Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20.
PubMed 25454613Becker B, Gadzhiev N, Popiolek M, Gross AJ, Netsch C. [A mobile app for patients suffering from kidney stones]. Urologe A. 2018 May;57(5):577-582. doi: 10.1007/s00120-018-0652-0. German.
PubMed 29713752Gadjiev N.K., Gorelov D.S., Akopyan G.N., Gelig V.A., Ivanov A.O., Petrov S.B., Kryukova N.U., Reva S.A., Ponomareva Yu.A., Al-Shukri A.S., Mischenko A.A., Kogai M.A., Vasiliev V.N., Chernysheva D.Yu., Obidnyak V.M., Makar'in V.A., Pisarev A.V., Zakuckij A.N., Kuzmin I.V., Amdiy R.E., Korneyev I.A., Al-Shukri S.H. "Schools for Patients" with Urolithiasis and Prostatic Diseases. Vestnik Urologii. 2020;8(1):110-120. (In Russ.) https://doi.org/10.21886/2308-6424-2020-8-1-110-120
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Fluid Intake Recommendations After Stone Removal in Low Risk Group Patients
- ClinicalTrials.gov ID
- NCT05329389
- Acronym / sponsor ID
- StoneMD_Schools_for_patients
- Conditions
- Urolithiasis
- Keywords
- application, StoneMD, Schools of patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Gadzhiev NarimanUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 4 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cumulative risk of stone recurrence rate is up to 14% at 1 year, 35% at 5 years, and 52% at 10 years. Low urine volume caused by insufficient fluid consumption is one of the most crucial risk factors for kidney stone formation. According to the guidelines, a copious fluid intake to maintain a urine volume of at least 2.0 to 2.5 L/24 h is recommended for most kidney stone formers. Patients often find it difficult to follow the recommendations in fluid intake, which leads to stone recurrence. Therefore, there is a need to improve patient compliance and adherence to following the instructions on keeping water balance. For this purpose we developed a mixed educational program including two parts. The first is the mobile application called "StoneMD: Kidney Stones". The second is the "School for Patients" with kidney stones, which is responsible for the stone clinic effect.
Detailed description
The aim of the study is to test the hypothesis that using mixed educational program additionally to standard recommendations in patients after the first stone surgery episode helps to achieve better adherence to daily fluid intake recommendations than the using standard recommendations alone given at the day of discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In case of presence/absence of inclusion/exclusion criteria and written informed consent will be obtained, patients will be randomized in a 1:1:1 ratio according to the list of randomized blocks using a computer generator. Patients will be randomized at the last available moment in order to minimize bias.
| Arm | Type | Receives |
|---|---|---|
| StoneMD | Experimental | Device: StoneMD, Behavioral: Standard recommendationPatients will receive standard recommendations of keeping diuresis at the level of 2.5 l/day and to use the StoneMD application on their smartphones after the surgery. Patients will use the section "Water balance" and follow the instructions during the 12 month after the surgery. |
| StoneMD & Schools of Patients | Experimental | Device: StoneMD, Behavioral: Schools of Patients, Behavioral: Standard recommendationPatients will receive standard recommendations of keeping diuresis at the level of 2.5 l/day and and recommendations to use the StoneMD application on their smartphones after the surgery. Patients will use the section "Water balance" and follow the instructions during the 12 month after the surgery. Additionally, patients will visit schools during a following year. Patients receive 4 consultations (one per 3 month). |
| Recommendations only | Active comparator | Behavioral: Standard recommendationOnly fluid balance recommendations given at the day of discharge. Patients will receive recommendations of keeping diuresis at the level of 2.5 l/day after the surgery |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Low risk recurrence group patients;
- Patients after the first stone surgery;
Key exclusion criteria (3 listed)
- Recurrent cases of stone formation;
- Patients, who do not have smartphones;
- Patients, who can't visit "Schools for Patients" with kidney stone disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StoneMDStoneMD - is an app from App Store (for iOS) or Google Play (for Android). | Device | StoneMD, StoneMD & Schools of Patients |
| Schools of PatientsThe "Schools for Patients" with Urolithiasis is an online course for patients with urinary stone disease. | Behavioural | StoneMD & Schools of Patients |
| Standard recommendationOnly fluid balance recommendations given at the day of discharge. | Behavioural | Recommendations only, StoneMD, StoneMD & Schools of Patients |
Primary outcome
Volume of daily urine
Time frame: 12 month after the surgery
The primary outcome will be measured in the lab in international units of measurement
Concentration of creatinine in daily urine
Time frame: 12 month after the surgery
The primary outcome will be measured in the lab in international units of measurement
1 secondary outcome
Likert scale questionnaire scores
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 2688503Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
- Background: PubMed 14681713Siener R, Hesse A. Fluid intake and epidemiology of urolithiasis. Eur J Clin Nutr. 2003 Dec;57 Suppl 2:S47-51. doi: 10.1038/sj.ejcn.1601901.
- Background: PubMed 25454613Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20.
- Background: PubMed 29713752Becker B, Gadzhiev N, Popiolek M, Gross AJ, Netsch C. [A mobile app for patients suffering from kidney stones]. Urologe A. 2018 May;57(5):577-582. doi: 10.1007/s00120-018-0652-0. German.
- BackgroundGadjiev N.K., Gorelov D.S., Akopyan G.N., Gelig V.A., Ivanov A.O., Petrov S.B., Kryukova N.U., Reva S.A., Ponomareva Yu.A., Al-Shukri A.S., Mischenko A.A., Kogai M.A., Vasiliev V.N., Chernysheva D.Yu., Obidnyak V.M., Makar'in V.A., Pisarev A.V., Zakuckij A.N., Kuzmin I.V., Amdiy R.E., Korneyev I.A., Al-Shukri S.H. "Schools for Patients" with Urolithiasis and Prostatic Diseases. Vestnik Urologii. 2020;8(1):110-120. (In Russ.) https://doi.org/10.21886/2308-6424-2020-8-1-110-120
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nariman Gadzhiev, PhD principal investigator
Deputy Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StoneMD, Schools of Patients and Standard recommendation in people with Urolithiasis, run by Gadzhiev Nariman at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vitalii Gelig, MD (+7 905 200-83-68, vgelig@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of daily urine (time frame: 12 month after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329389, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.