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Table 1 Baseline screening, assessment, and follow-up schedule

From: Effect of transcutaneous electrical stimulation treatment on lower urinary tract symptoms after class III radical hysterectomy in cervical cancer patients: study protocol for a multicentre, randomized controlled trial

 

At baseline

Time after surgery

Early withdrawal

14 days

21 days

28 days

3 months

6 months

12 months

18 months

24 months

Follow-up time window (days)

 

±2

±2

±2

±7

±7

±7

±7

±7

 

Informed consent

         

Demographic characteristics

         

Socioeconomic status

         

Medical history

         

Information on tumor clinical evaluation and surgical operation

         

Physical examination

         

Blood routine examination

   

 

Blood clotting function

         

Routine urine test

   

 

Routine stool test

   

 

Blood biochemistry

   

 

Hormone testinga

   

Tumor biomarkersb

   

Gynecological examinationc

   

Abdominal/pelvic CT/MRI

Chess X-ray

    

Randomization

         

Assessment of residual urined

 

   

Uroflowmetry

   

     

Urodynamic tests

   

      

Anorectal function evaluation

   

      

Pelvic floor functional testing

   

     

EQ-5De

    

 

 

PISQ-12f

     

 

 

PFDI-20g

    

 

 

ICIQ/OABssh

    

 

 

Adverse events

   

  1. : Indicates mandatory items
  2. ▲: Investigator will decide whether to perform the testi according to clinical signs or clinical evaluation
  3. aHormone testing includes estradiol, progesterone, testosterone, prolactin, follotropin and luteinizing hormone
  4. bTumor biomarkers includes squamous cell carcinoma antigen, CA125, CA199 and carcinoembryonic antigen
  5. cGynecological examination includes Human Papillomavirus and Thinprep Cytological Testing
  6. dResidual urine is evaluated by B ultrasound
  7. eEQ-5D: European Quality of Life-5 Dimensions
  8. fPISQ-12: Prolapse/Urinary Incontinence Sexual Questionnaire short form
  9. gPFDI-20: Pelvic Floor Distress Inventory
  10. hICIQ/OABss: International Consultation on Incontinence Questionnaire/Overactive Bladder Symptom Score