Objective Assessment of the Effect of Comprehensive Spa Care on Patients With Chronic Kidney and Urological Diseases: A Prospective Interventional Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in serum creatinine level from baseline to day 21
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Comprehensive Spa Care (KLP)
Patients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment.
干预措施: Comprehensive Spa Care (Other)
Comprehensive Spa Care (KLP)
Patients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment.
干预措施: Exercise Therapy (Behavioral)
Comprehensive Spa Care (KLP)
Patients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment.
干预措施: Dietotherapy (Dietary Supplement)
Comprehensive Spa Care (KLP)
Patients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment.
干预措施: Mineral Water Drinking Cure (Dietary Supplement)
Comprehensive Spa Care (KLP)
Patients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment.
干预措施: Mineral Water Bath Therapy (Procedure)
Comprehensive Spa Care (KLP)
Patients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment.
干预措施: Peloid Therapy (Procedure)
Comprehensive Spa Care (KLP)
Patients with nephrological and urological conditions (indications VIII/1-VIII/4) undergoing standard 21-day comprehensive spa care program in Mariánské Lázně. All participants receive the same intervention with assessments at baseline and at the end of treatment.
干预措施: Carbon Dioxide Therapy (Procedure)
结局指标
主要结局
Change in serum creatinine level from baseline to day 21
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
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
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
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
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
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
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Change in quantitative microbiological urine culture results from baseline to day 21
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
Quantitative bacteriological culture of first morning midstream urine. Evaluated separately for patients with negative and positive baseline findings.
Change in serum uric acid level from baseline to day 21
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
Uric acid measured in venous blood \[µmol/l\]. Evaluated separately for patients with normal and elevated baseline values.
Change in serum potassium level from baseline to day 21
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Change in serum calcium level from baseline to day 21
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
Change in serum phosphorus level from baseline to day 21
时间窗: Baseline (day 1-3) and end of treatment (day 19-21)
Electrolytes measured in venous blood. Evaluated separately for patients with normal, elevated, and decreased baseline values.
次要结局
- Change in EQ-5D-5L Index Value from Baseline to Day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in EQ-5D-5L Visual Analogue Scale (EQ VAS) Score from Baseline to Day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in ICIQ-FLUTS (women) or ICIQ-MLUTS (men) scores from baseline to day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in ultrasound findings of kidneys, urinary bladder, and urinary tract from baseline to day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in body composition parameters from baseline to day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in Systolic Blood Pressure from Baseline to Day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in Diastolic Blood Pressure from Baseline to Day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in Resting Heart Rate from Baseline to Day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in Body Mass Index from Baseline to Day 21(Baseline (day 1-3) and end of treatment (day 19-21))
- Change in Waist Circumference from Baseline to Day 21(Baseline (day 1-3) and end of treatment (day 19-21))