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).
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
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
Single group
Comprehensive Spa Care
Other interventionA 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 Therapy
BehavioralIndividually 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 supplementIndividualized 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 supplementTherapeutic 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/SurgeryTherapeutic 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/SurgeryApplication 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/SurgeryTherapeutic 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.
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.
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.
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.
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.
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)
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)
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.
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.
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Institute of Spa and Balneology, public research institution
Lead sponsor
Léčebné lázně Mariánské Lázně a. s.
Collaborator
