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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorInstitute of Spa and Balneology, public research institution

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Comprehensive Spa Care
  • Exercise Therapy
  • Dietotherapy
  • Mineral Water Drinking Cure
  • Mineral Water Bath Therapy
  • Peloid Therapy
  • Carbon Dioxide Therapy

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators

Institute of Spa and Balneology, public research institution

Lead sponsor

Léčebné lázně Mariánské Lázně a. s.

Collaborator