NCT07435844

Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients

Objective Assessment of the Effect of Comprehensive Spa Care on Patients With Chronic Kidney and Urological Diseases: A Prospective Interventional Clinical Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Institute of Spa and Balneology, public research institution · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
OTHER	Comprehensive Spa Care	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.
BEHAVIORAL	Exercise Therapy	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.
DIETARY_SUPPLEMENT	Dietotherapy	Individualized dietotherapy combined with nutritional counseling provided by a qualified healthcare professional. The intervention includes dietary assessment, education on healthy nutrition, hydratio
DIETARY_SUPPLEMENT	Mineral Water Drinking Cure	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.
PROCEDURE	Mineral Water Bath 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.
PROCEDURE	Peloid Therapy	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.
PROCEDURE	Carbon Dioxide Therapy	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.

Timeline

• Start date: 2026-02-16
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2026-02-27
• Last updated: 2026-02-27