Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients
Uro-Nefro
Objective Assessment of the Effect of Comprehensive Spa Care on Patients With Chronic Kidney and Urological Diseases: A Prospective Interventional Clinical Study
1 other identifier
interventional
150
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedStudy Start
First participant enrolled
April 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
April 24, 2026
February 1, 2026
1.1 years
February 13, 2026
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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.
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)
Secondary Outcomes (10)
Change in EQ-5D-5L Index Value from Baseline to Day 21
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
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
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
Baseline (day 1-3) and end of treatment (day 19-21)
Change in body composition parameters from baseline to day 21
Baseline (day 1-3) and end of treatment (day 19-21)
- +5 more secondary outcomes
Study Arms (1)
Comprehensive Spa Care (KLP)
EXPERIMENTALPatients 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.
Interventions
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.
Individualized dietotherapy combined with nutritional counseling provided by a qualified healthcare professional. The intervention includes dietary assessment, education on healthy nutrition, hydratio
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Severe comorbidities that could affect treatment outcomes
- Active oncological disease
- Unwillingness to adhere to the treatment plan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Léčebné lázně Mariánské Lázně a.s.
Mariánské Lázně, Carlsbad Region, 353 43, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2026
First Posted
February 27, 2026
Study Start
April 7, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
April 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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).