Urologic DiseasesUro-NefroNCT07435844
Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients
A study testing Comprehensive Spa Care, Exercise Therapy and Dietotherapy in people with Urologic Diseases and Urinary Tract Infections, run by Institute of Spa and Balneology, public research institution at 1 site in Czechia.
Trial summary
This is a single-arm, pretest-posttest study evaluating the effects of a 21-day comprehensive spa care (Komplexní lázeňská léčebně rehabilitační péče, KLP) on patients with nephrological and urological conditions treated at a spa facility in Mariánské Lázně, Czech Republic. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Urologic Diseases, Urinary Tract Infections, Nephrolithiasis
- What is being tested?
- Comprehensive Spa Care, Exercise Therapy and Dietotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 40 to 70 years
- Prescribed comprehensive spa care (KLP) for one of the following indications: recurrent and chronic non-tuberculous inflammation of the kidneys and urinary tract resistant to antibiotic and pharmacological treatment, with at least 12 months of continuous urological care (indication VIII/1); cystic kidney disease (indication VIII/1); nephrolithiasis without urinary tract obstruction or nephrocalcinosis (indication VIII/2); conditions after kidney or urinary tract surgery, including endovesical procedures, complicated prostatectomy, nephrolithotripsy, or recovery after extracorporeal shock wave lithotripsy (indication VIII/3); chronic prostatitis or chronic prostatovesiculitis resistant to pharmacological and antibiotic treatment, with at least 12 months of continuous urological care (indication VIII/4)
- Able to walk from the sanatorium to the colonnade and back three times daily
- Willing to follow the treatment plan
- Signed informed consent
Who cannot join
- Contraindications according to Czech Decree No. 2/2015 Coll. on spa treatment criteria (pregnancy, acute illness, etc.)
- Significant mobility limitation or severe neuropathy preventing daily walks to the colonnade
- Significant obesity or inability to briefly hold breath (required for ultrasound examination)
- Alcohol intake exceeding 20 g of ethanol per day
- Nephrolithiasis with urinary tract obstruction
- History of esophageal or gastric variceal bleeding
Show all 9Show fewer
- Severe comorbidities that could affect treatment outcomes
- Active oncological disease
- Unwillingness to adhere to the treatment plan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Léčebné lázně Mariánské Lázně a.s.
Mariánské Lázně, Carlsbad Region, 353 43
About this study
Official title: Objective Assessment of the Effect of Comprehensive Spa Care on Patients With Chronic Kidney and Urological Diseases: A Prospective Interventional Clinical Study
This is a single-arm, pretest-posttest study evaluating the effects of a 21-day comprehensive spa care (Komplexní lázeňská léčebně rehabilitační péče, KLP) on patients with nephrological and urological conditions treated at a spa facility in Mariánské Lázně, Czech Republic.
The study enrolls 150 adult patients (75 men and 75 women), aged 40-70 years, who are prescribed KLP for indications VIII/1 (recurrent and chronic non-tuberculous inflammation of the kidneys and urinary tract), VIII/2 (nephrolithiasis without urinary tract obstruction, nephrocalcinosis), VIII/3 (conditions after kidney and urinary tract surgery), and VIII/4 (chronic prostatitis or prostatovesiculitis resistant to pharmacological treatment).
Read more
The spa treatment consists of the use of natural healing resources of Mariánské Lázně, including a mineral spring drinking cure, balneotherapy (mineral water baths), peloid therapy, carbon dioxide therapy, climatotherapy, exercise therapy, and dietotherapy. The standard treatment duration is 21 days, during which each patient receives a total of 63 therapeutic procedures and drinks mineral spring water three times daily.
Patients undergo assessments at the beginning (days 1-3) and at the end (days 19-21) of their treatment. Assessments include physical examination, abdominal and urinary tract ultrasound, blood and urine sampling with laboratory analysis, body composition measurement using bioelectrical impedance analysis (InBody), and psychometric questionnaire surveys.
The primary aim of the study is to objectively assess the therapeutic effect of comprehensive spa care on nephrological and urological diseases by comparing pre-treatment and post-treatment clinical, laboratory, and patient-reported outcomes.
The study was approved by the Ethics Committee of the University Hospital and Faculty of Medicine in Pilsen (decision of November 2, 2023, ref. no. 437/23).
Read the detailed description
STUDY DESIGN AND SETTING:
This is a prospective, single-arm study using a one-group pretest-posttest design conducted at a spa facility in Mariánské Lázně, Czech Republic. The study evaluates the effects of standard comprehensive spa care on patients with nephrological and urological conditions (indication group VIII). The treatment is provided as part of routine clinical care covered by health insurance. The study does not modify the treatment protocol; it collects clinical data before and after the treatment to objectively assess its effects.
INTERVENTION:
The intervention is a standard 21-day comprehensive spa care program (KLP) prescribed for indication group VIII. The treatment is based on the natural healing resources specific to Mariánské Lázně and includes: drinking cure using local mineral springs (three times daily), mineral water baths, peloid therapy (peat applications), carbon dioxide therapy, climatotherapy, exercise therapy, and dietotherapy with nutritional counseling. Additional procedures may be prescribed by the spa physician based on individual patient assessment. Each patient receives a total of 63 therapeutic procedures during the 21-day stay.
ASSESSMENT SCHEDULE:
All assessments are performed at two time points: at the beginning of KLP (no later than day 3 after admission) and at the end of KLP (day 20 or 21, exceptionally day 19).
Blood samples (5 ml serum in a red-top tube and 3 ml K3EDTA in a purple-top tube) and urine samples (one unpreserved tube) are collected in the morning under fasting conditions at both time points. Laboratory analysis is performed by an external certified laboratory. A total of 300 sample collections are planned (150 at entry, 150 at exit).
Physical examinations and ultrasound assessments of the kidneys, urinary bladder, urinary tract, and (in male patients) the prostate are performed at both time points by a urologist. Body composition is measured using bioelectrical impedance analysis (InBody device). Questionnaire-based assessments are administered at both time points.
DATA MANAGEMENT:
All patient data are pseudonymized using unique ID codes assigned at enrollment. Data are collected in both paper and electronic form. Paper records are stored in individual binders organized by patient ID. Electronic data are transferred to the Institute of Spa Medicine and Balneology (ILaB) on a password-protected, AES-128 encrypted USB drive at regular two-month intervals. Data handling complies with EU General Data Protection Regulation (GDPR, Regulation 2016/679) and Good Clinical Practice principles. ILaB is responsible for the final statistical analysis and interpretation of the collected data.
ETHICAL CONSIDERATIONS:
The study was approved by the Ethics Committee of the University Hospital and Faculty of Medicine in Pilsen. All participants provide written informed consent before enrollment. The study procedures (ultrasound, blood and urine sampling, questionnaires) represent minimal risk and negligible additional burden compared to standard care.
- Conditions
- Urologic Diseases, Urinary Tract Infections, Nephrolithiasis, Nephrocalcinosis, Prostatism, Kidney Diseases
- Being tested
- Comprehensive Spa Care, Exercise Therapy, Dietotherapy, Mineral Water Drinking Cure, Mineral Water Bath Therapy
- Keywords
- Balneotherapy, Spa Treatment, Mineral Water Drinking Cure, Mariánské Lázně, Nephrology, Urology, comprehensive spa care
- Medical subject headings
- Urologic Diseases, Urinary Tract Infections, Nephrolithiasis, Nephrocalcinosis, Prostatism, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Spa CareOther
A 21-day comprehensive spa care program based on natural healing resources of Mariánské Lázně, including mineral spring drinking cure (three times daily), mineral water baths, peloid therapy, carbon dioxide therapy, climatotherapy, exercise therapy, dietotherapy with nutritional counseling, and additional procedures prescribed individually by the spa physician. Each patient receives a total of 63 therapeutic procedures during the treatment period.
Exercise TherapyBehavioural
Individually prescribed therapeutic exercise program supervised by qualified physiotherapists. The intervention includes aerobic training, strength exercises, mobility and flexibility training, breathing exercises, and functional rehabilitation adapted to the patient's clinical condition. The aim is to improve physical capacity, functional independence, cardiovascular fitness, and overall rehabilitation outcomes during the comprehensive spa treatment program.
DietotherapyDietary supplement
Individualized dietotherapy combined with nutritional counseling provided by a qualified healthcare professional. The intervention includes dietary assessment, education on healthy nutrition, hydratio
Mineral Water Drinking CureDietary supplement
Therapeutic administration of natural mineral water from Mariánské Lázně springs, typically consumed three times daily according to medical prescription. The intervention aims to support renal function, urinary tract health, metabolic regulation, and hydration status as part of comprehensive spa therapy.
Mineral Water Bath TherapyProcedure or surgery
Therapeutic bathing using natural mineral water under controlled temperature and duration conditions. The intervention promotes relaxation, peripheral circulation improvement, neuromuscular relaxation, and recovery processes within the comprehensive spa treatment program.
Peloid TherapyProcedure or surgery
Application of natural therapeutic mud (peloids) in the form of wraps or local applications. The intervention provides thermal and chemical stimulation intended to reduce pain, improve circulation, decrease muscle tension, and support musculoskeletal and regenerative processes.
Carbon Dioxide TherapyProcedure or surgery
Therapeutic administration of carbon dioxide through dry carbon dioxide baths or subcutaneous carbon dioxide applications according to spa medical prescription. The intervention aims to improve microcirculation, vascular function, tissue oxygenation, and autonomic regulation.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Spa Care (KLP) | Experimental | Patients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment. Receives: Other: Comprehensive Spa Care; Behavioral: Exercise Therapy; Dietary Supplement: Dietotherapy; Dietary Supplement: Mineral Water Drinking Cure; Procedure: Mineral Water Bath Therapy; Procedure: Peloid Therapy; Procedure: Carbon Dioxide Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum creatinine level from baseline to day 21
Serum creatinine measured in venous blood [µmol/l]. Evaluated separately for patients with normal and elevated baseline values.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in serum cystatin C level from baseline to day 21
Cystatin C measured in venous blood [mg/l]. Evaluated separately for patients with normal and elevated baseline values.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in eGFR calculated by CKD-EPI EKFC equation from baseline to day 21
eGFR calculated from serum creatinine using the European Kidney Function Consortium (EKFC) equation [ml/s per 1.73 m²]. Evaluated separately for patients with normal and reduced baseline values.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in serum sodium level from baseline to day 21
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in quantitative microbiological urine culture results from baseline to day 21
Quantitative bacteriological culture of first morning midstream urine. Evaluated separately for patients with negative and positive baseline findings.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in serum uric acid level from baseline to day 21
Uric acid measured in venous blood [µmol/l]. Evaluated separately for patients with normal and elevated baseline values.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in serum potassium level from baseline to day 21
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in serum calcium level from baseline to day 21
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in serum phosphorus level from baseline to day 21
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Secondary outcomes (10)
Change in EQ-5D-5L Index Value from Baseline to Day 21
EuroQol EQ-5D-5L questionnaire assessing five dimensions of health-related quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Index value (range typically -0.285 to 1.000; higher scores indicate better health status)
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in EQ-5D-5L Visual Analogue Scale (EQ VAS) Score from Baseline to Day 21
Self-rated overall health measured using the EuroQol Visual Analogue Scale (EQ VAS), where participants rate their current health status on a vertical scale.
Score (0-100; higher scores indicate better perceived health)
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in ICIQ-FLUTS (women) or ICIQ-MLUTS (men) scores from baseline to day 21
Sex-specific International Consultation on Incontinence Questionnaire assessing lower urinary tract symptoms. ICIQ-FLUTS for female participants, ICIQ-MLUTS for male participants.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in ultrasound findings of kidneys, urinary bladder, and urinary tract from baseline to day 21
Transabdominal ultrasound examination of kidneys, urinary bladder, and urinary tract performed by a urologist. In male patients, prostate examination included.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in body composition parameters from baseline to day 21
Body composition measured by InBody device, including total body water (extracellular and intracellular), total body fat percentage, and total muscle mass percentage.
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Systolic Blood Pressure from Baseline to Day 21
Systolic blood pressure measured in the morning in a seated resting position using a validated automated sphygmomanometer.
mmHg (lower values indicate improvement)
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Diastolic Blood Pressure from Baseline to Day 21
Diastolic blood pressure measured in the morning in a seated resting position using a validated automated sphygmomanometer.
mmHg (lower values indicate improvement)
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Resting Heart Rate from Baseline to Day 21
Resting heart rate measured in the morning after at least five minutes of seated rest.
beats per minute (bpm; lower values indicate improvement)
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Body Mass Index from Baseline to Day 21
Body mass index calculated as body weight divided by height squared. kg/m² (lower values indicate improvement)
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Waist Circumference from Baseline to Day 21
Waist circumference measured at the umbilical level using a standardized measuring tape.
centimeters (cm; lower values indicate improvement)
Measured: Baseline (day 1-3) and end of treatment (day 19-21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start7 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Spa and Balneology, public research institution
- Sponsor type
- University, hospital or other
- Collaborators
- Léčebné lázně Mariánské Lázně a. s.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435844
- Sponsor's protocol ID
- UN_437/23
- Acronym
- Uro-Nefro
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. All data are pseudonymized and handled in accordance with EU General Data Protection Regulation (GDPR). Data access is restricted to the research team at the Institute of Spa Medicine and Balneology (ILaB).
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of the Effect of Comprehensive Spa Care on Patients With Chronic Kidney and Urological Diseases: A Prospective Interventional Clinical Study
- ClinicalTrials.gov ID
- NCT07435844
- Acronym / sponsor ID
- Uro-Nefro / UN_437/23
- Conditions
- Urologic Diseases, Urinary Tract Infections, Nephrolithiasis, Nephrocalcinosis, Prostatism, Kidney Diseases
- Keywords
- Balneotherapy, Spa Treatment, Mineral Water Drinking Cure, Mariánské Lázně, Nephrology, Urology, comprehensive spa care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Spa and Balneology, public research institutionUniversity, hospital or other
- Collaborators
- Léčebné lázně Mariánské Lázně a. s.
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
This is a single-arm, pretest-posttest study evaluating the effects of a 21-day comprehensive spa care (Komplexní lázeňská léčebně rehabilitační péče, KLP) on patients with nephrological and urological conditions treated at a spa facility in Mariánské Lázně, Czech Republic.
The study enrolls 150 adult patients (75 men and 75 women), aged 40-70 years, who are prescribed KLP for indications VIII/1 (recurrent and chronic non-tuberculous inflammation of the kidneys and urinary tract), VIII/2 (nephrolithiasis without urinary tract obstruction, nephrocalcinosis), VIII/3 (conditions after kidney and urinary tract surgery), and VIII/4 (chronic prostatitis or prostatovesiculitis resistant to pharmacological treatment).
The spa treatment consists of the use of natural healing resources of Mariánské Lázně, including a mineral spring drinking cure, balneotherapy (mineral water baths), peloid therapy, carbon dioxide therapy, climatotherapy, exercise therapy, and dietotherapy. The standard treatment duration is 21 days, during which each patient receives a total of 63 therapeutic procedures and drinks mineral spring water three times daily.
Patients undergo assessments at the beginning (days 1-3) and at the end (days 19-21) of their treatment. Assessments include physical examination, abdominal and urinary tract ultrasound, blood and urine sampling with laboratory analysis, body composition measurement using bioelectrical impedance analysis (InBody), and psychometric questionnaire surveys.
The primary aim of the study is to objectively assess the therapeutic effect of comprehensive spa care on nephrological and urological diseases by comparing pre-treatment and post-treatment clinical, laboratory, and patient-reported outcomes.
The study was approved by the Ethics Committee of the University Hospital and Faculty of Medicine in Pilsen (decision of November 2, 2023, ref. no. 437/23).
Detailed description
STUDY DESIGN AND SETTING:
This is a prospective, single-arm study using a one-group pretest-posttest design conducted at a spa facility in Mariánské Lázně, Czech Republic. The study evaluates the effects of standard comprehensive spa care on patients with nephrological and urological conditions (indication group VIII). The treatment is provided as part of routine clinical care covered by health insurance. The study does not modify the treatment protocol; it collects clinical data before and after the treatment to objectively assess its effects.
INTERVENTION:
The intervention is a standard 21-day comprehensive spa care program (KLP) prescribed for indication group VIII. The treatment is based on the natural healing resources specific to Mariánské Lázně and includes: drinking cure using local mineral springs (three times daily), mineral water baths, peloid therapy (peat applications), carbon dioxide therapy, climatotherapy, exercise therapy, and dietotherapy with nutritional counseling. Additional procedures may be prescribed by the spa physician based on individual patient assessment. Each patient receives a total of 63 therapeutic procedures during the 21-day stay.
ASSESSMENT SCHEDULE:
All assessments are performed at two time points: at the beginning of KLP (no later than day 3 after admission) and at the end of KLP (day 20 or 21, exceptionally day 19).
Blood samples (5 ml serum in a red-top tube and 3 ml K3EDTA in a purple-top tube) and urine samples (one unpreserved tube) are collected in the morning under fasting conditions at both time points. Laboratory analysis is performed by an external certified laboratory. A total of 300 sample collections are planned (150 at entry, 150 at exit).
Physical examinations and ultrasound assessments of the kidneys, urinary bladder, urinary tract, and (in male patients) the prostate are performed at both time points by a urologist. Body composition is measured using bioelectrical impedance analysis (InBody device). Questionnaire-based assessments are administered at both time points.
DATA MANAGEMENT:
All patient data are pseudonymized using unique ID codes assigned at enrollment. Data are collected in both paper and electronic form. Paper records are stored in individual binders organized by patient ID. Electronic data are transferred to the Institute of Spa Medicine and Balneology (ILaB) on a password-protected, AES-128 encrypted USB drive at regular two-month intervals. Data handling complies with EU General Data Protection Regulation (GDPR, Regulation 2016/679) and Good Clinical Practice principles. ILaB is responsible for the final statistical analysis and interpretation of the collected data.
ETHICAL CONSIDERATIONS:
The study was approved by the Ethics Committee of the University Hospital and Faculty of Medicine in Pilsen. All participants provide written informed consent before enrollment. The study procedures (ultrasound, blood and urine sampling, questionnaires) represent minimal risk and negligible additional burden compared to standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Spa Care (KLP) | Experimental | Other: Comprehensive Spa Care, Behavioral: Exercise Therapy, Dietary Supplement: Dietotherapy, Dietary Supplement: Mineral Water Drinking Cure, Procedure: Mineral Water Bath Therapy, Procedure: Peloid Therapy, Procedure: Carbon Dioxide TherapyPatients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 40 to 70 years
- Prescribed comprehensive spa care (KLP) for one of the following indications: recurrent and chronic non-tuberculous inflammation of the kidneys and urinary tract resistant to antibiotic and pharmacological treatment, with at least 12 months of continuous urological care (indication VIII/1); cystic kidney disease (indication VIII/1); nephrolithiasis without urinary tract obstruction or nephrocalcinosis (indication VIII/2); conditions after kidney or urinary tract surgery, including endovesical procedures, complicated prostatectomy, nephrolithotripsy, or recovery after extracorporeal shock wave lithotripsy (indication VIII/3); chronic prostatitis or chronic prostatovesiculitis resistant to pharmacological and antibiotic treatment, with at least 12 months of continuous urological care (indication VIII/4)
- Able to walk from the sanatorium to the colonnade and back three times daily
- Willing to follow the treatment plan
- Signed informed consent
Key exclusion criteria (9 listed)
- Contraindications according to Czech Decree No. 2/2015 Coll. on spa treatment criteria (pregnancy, acute illness, etc.)
- Significant mobility limitation or severe neuropathy preventing daily walks to the colonnade
- Significant obesity or inability to briefly hold breath (required for ultrasound examination)
- Alcohol intake exceeding 20 g of ethanol per day
- Nephrolithiasis with urinary tract obstruction
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 |
|---|---|---|
| Comprehensive Spa CareA 21-day comprehensive spa care program based on natural healing resources of Mariánské Lázně, including mineral spring drinking cure (three times daily), mineral water baths, peloid therapy, carbon dioxide therapy, climatotherapy, exercise therapy, dietotherapy with nutritional counseling, and additional procedures prescribed individually by the spa physician. Each patient receives a total of 63 therapeutic procedures during the treatment period. | Other | Comprehensive Spa Care (KLP) |
| Exercise TherapyIndividually prescribed therapeutic exercise program supervised by qualified physiotherapists. The intervention includes aerobic training, strength exercises, mobility and flexibility training, breathing exercises, and functional rehabilitation adapted to the patient's clinical condition. The aim is to improve physical capacity, functional independence, cardiovascular fitness, and overall rehabilitation outcomes during the comprehensive spa treatment program. | Behavioural | Comprehensive Spa Care (KLP) |
| DietotherapyIndividualized dietotherapy combined with nutritional counseling provided by a qualified healthcare professional. The intervention includes dietary assessment, education on healthy nutrition, hydratio | Dietary supplement | Comprehensive Spa Care (KLP) |
| Mineral Water Drinking CureTherapeutic administration of natural mineral water from Mariánské Lázně springs, typically consumed three times daily according to medical prescription. The intervention aims to support renal function, urinary tract health, metabolic regulation, and hydration status as part of comprehensive spa therapy. | Dietary supplement | Comprehensive Spa Care (KLP) |
| Mineral Water Bath TherapyTherapeutic bathing using natural mineral water under controlled temperature and duration conditions. The intervention promotes relaxation, peripheral circulation improvement, neuromuscular relaxation, and recovery processes within the comprehensive spa treatment program. | Procedure or surgery | Comprehensive Spa Care (KLP) |
| Peloid TherapyApplication of natural therapeutic mud (peloids) in the form of wraps or local applications. The intervention provides thermal and chemical stimulation intended to reduce pain, improve circulation, decrease muscle tension, and support musculoskeletal and regenerative processes. | Procedure or surgery | Comprehensive Spa Care (KLP) |
| Carbon Dioxide TherapyTherapeutic administration of carbon dioxide through dry carbon dioxide baths or subcutaneous carbon dioxide applications according to spa medical prescription. The intervention aims to improve microcirculation, vascular function, tissue oxygenation, and autonomic regulation. | Procedure or surgery | Comprehensive Spa Care (KLP) |
Primary outcome
Change in serum creatinine level from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Serum creatinine measured in venous blood [µmol/l]. Evaluated separately for patients with normal and elevated baseline values.
Change in serum cystatin C level from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Cystatin C measured in venous blood [mg/l]. Evaluated separately for patients with normal and elevated baseline values.
Change in eGFR calculated by CKD-EPI EKFC equation from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
eGFR calculated from serum creatinine using the European Kidney Function Consortium (EKFC) equation [ml/s per 1.73 m²]. Evaluated separately for patients with normal and reduced baseline values.
Change in serum sodium level from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Change in quantitative microbiological urine culture results from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Quantitative bacteriological culture of first morning midstream urine. Evaluated separately for patients with negative and positive baseline findings.
Change in serum uric acid level from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Uric acid measured in venous blood [µmol/l]. Evaluated separately for patients with normal and elevated baseline values.
Change in serum potassium level from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Change in serum calcium level from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Change in serum phosphorus level from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
10 secondary outcomes
Change in EQ-5D-5L Index Value from Baseline to Day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in EQ-5D-5L Visual Analogue Scale (EQ VAS) Score from Baseline to Day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in ICIQ-FLUTS (women) or ICIQ-MLUTS (men) scores from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in ultrasound findings of kidneys, urinary bladder, and urinary tract from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in body composition parameters from baseline to day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Systolic Blood Pressure from Baseline to Day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Diastolic Blood Pressure from Baseline to Day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Resting Heart Rate from Baseline to Day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Body Mass Index from Baseline to Day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Change in Waist Circumference from Baseline to Day 21
Time frame: Baseline (day 1-3) and end of treatment (day 19-21)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. All data are pseudonymized and handled in accordance with EU General Data Protection Regulation (GDPR). Data access is restricted to the research team at the Institute of Spa Medicine and Balneology (ILaB).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Spa Care, Exercise Therapy and Dietotherapy in people with Urologic Diseases and Urinary Tract Infections, run by Institute of Spa and Balneology, public research institution at 1 site in Czechia.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ondřej Vacek, Mgr. (+420 603 934 414, vacek@i-lab.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum creatinine level from baseline to day 21 (time frame: Baseline (day 1-3) and end of treatment (day 19-21)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.