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Table 2 The ADRESU study data collection schedule

From: Design of a single-arm clinical trial of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence in Japan: the ADRESU study protocol

 

Screening period

Operation

Observation period

Provisional registration

Registration

Day 0

Day 1

At end of hospitalization

Week 2

Week 4

Week 12

Week 26

Week 38

Week 52

Eligibility criteria

X

X

         

Vital signsa

  

X

X

X

X

     

Oxygen saturation

  

X

X

X

X

     

Laboratory tests

           

 Infectionsb

 

X

         

 Hematologyc, Biochemistryd, CRP, Coagulatione, Urinalysisf

 

X

 

X

X

X

X

X

X

 

X

 PSA

 

X

     

X

X

 

X

12 Lead electrocardiography

 

X

 

X

X

X

     

Chest X-rays

 

X

         

Urination diaryg

 

X

   

X

X

X

X

X

X

QOL scoresh

 

X

      

X

 

X

Patient overall satisfaction

 

X

      

X

 

X

Urodynamic parametersi

 

X

   

X

X

X

X

 

X

Transrectal ultrasonography

 

X

     

X

X

 

X

MRI

 

X

   

X

  

X

 

X

Liposuction

  

X

        

Periurethral injection of ADRCs, and mixture of ADRCs and fat

  

X

        

Concomitant therapies

X

X

X

X

X

X

X

X

X

X

X

Adverse events

X

X

X

X

X

X

X

X

X

X

X

  1. a Blood pressure, pulse rate, body temperature
  2. b HBs antigen, HCV antibody, HIV antibody, serologic test of syphilis
  3. c Red blood, hemoglobin, hematocrit, white blood cell count, fraction of leucocytes (basophil, eosinophil, neutrophil, lymphocyte, monocyte), platelet count
  4. d Total protein, albumin, total cholesterol, blood urea nitrogen, creatinine, uric acid, sodium, chloride, potassium, calcium, phosphate, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin, creatinine kinase
  5. e Prothrombin time, activated partial thromboplastin time, fibrinogen
  6. f pH, protein, glucose, urobilinogen, occult blood
  7. g Urine leakage volume, number of incontinence episodes, number of pads used
  8. h International Consultation on Incontinence Questionnaire-Short Form, King’s Health Questionnaire
  9. i Maximum urethral closing pressure, functional profile length, abdominal leak point pressure
  10. Abbreviations: CRP C-reactive protein, PSA Prostate-Specific Antigen, QOL quality of life, MRI magnetic resonance imaging, ADRCs adipose-derived regenerative cells