NCT07435844 Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients
| NCT ID | NCT07435844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Spa and Balneology, public research institution |
| Condition | Urologic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-07 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-04-07 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07435844 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Urologic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07435844 currently recruiting?
Yes, NCT07435844 is actively recruiting participants. Contact the research team at vacek@i-lab.cz for enrollment information.
Where is the NCT07435844 trial being conducted?
This trial is being conducted at Mariánské Lázně, Czechia.
Who is sponsoring the NCT07435844 clinical trial?
NCT07435844 is sponsored by Institute of Spa and Balneology, public research institution. The trial plans to enroll 150 participants.