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| Name | Class |
|---|---|
| Léčebné lázně Mariánské Lázně a. s. | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Spa Care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline (day 1-3) and end of treatment (day 19-21) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ondřej Vacek, Mgr. | Contact | +420 603 934 414 | vacek@i-lab.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Léčebné lázně Mariánské Lázně a.s. | Recruiting | Mariánské Lázně | Carlsbad Region | 353 43 | Czechia |
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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| Exercise Therapy | Behavioral | 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. |
|
| Dietotherapy | Dietary 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 Cure | Dietary 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 Therapy | Procedure | 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 Therapy | Procedure | 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 Therapy | Procedure | 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. |
|
| 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. | 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. | 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. | 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) | 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. | 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. | 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. | 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) | 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) | 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) | 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) | 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) | Baseline (day 1-3) and end of treatment (day 19-21) |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D014552 | Urinary Tract Infections |
| D053040 | Nephrolithiasis |
| D009397 | Nephrocalcinosis |
| D053448 | Prostatism |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D052878 | Urolithiasis |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D009094 | Mud Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D001452 | Balneology |
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