Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients
Recruiting · NCT07435844 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Spa and Balneology, public research institution
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed.
- Léčebné lázně Mariánské Lázně a.s. - Mariánské Lázně, Carlsbad Region, Czechia