Acupuncture for prostatectomy incontinence: study protocol for a multicenter single-blind randomized parallel controlled trial

Zhang, Yao; Guo, Shanqi; Wang, Chaoran; Liu, Xiaodi; Liu, Yan; Shang, Hongcai; Yang, Peiying; Wang, Liang; Zhai, Jingbo; Li, Xiaojiang; Jia, Yingjie

doi:10.1186/s13063-021-05805-5

Trials

Table 1 Study design schedule

From: Acupuncture for prostatectomy incontinence: study protocol for a multicenter single-blind randomized parallel controlled trial

Contents	Research period
	Screening	Baseline	Treatment (W1–6)				Follow-up (W7–24)
	W−1	W0	W1	W2	W4	W6	W12	W18	W24
Visit	V0	V1	V2	V3	V4	V5	V6	V7	V8
Name	×	×
Age	×	×
Contact information	×
Inclusion/exclusion criteria	×
Informed consent	×
Screening dispose	×
Randomization	×
Vital signs¹	×	×	×	×	×	×
Blood routine²	×	×				×
Urine routine³	×	×				×
Biochemical items⁴	×	×				×
ECG⁵	×	×				×
Height		×
Weight		×
BMI⁶		×
Education and occupation		×
Karnofsky score		×
ECOG score⁷		×
Personal history⁸		×
Past histories		×
Physical examination⁹		×	×	×	×	×
Diagnosis time		×
Pathological type		×
Gleason score		×
Clinical stages		×
Operation type		×
Treatment of PPI		×	×	×	×	×	×	×	×
Treatment of PCa		×	×	×	×	×	×	×	×
Daily water consumption		×	×	×	×	×	×	×	×
Drink preference		×	×	×	×	×	×	×	×
Postoperative extubation time		×
Time of incontinence		×
ICIQ-UI SF¹⁰		×				×	×	×	×
1-h pad test		×			×	×
72-h voiding diary		×	×	×	×	×	×	×	×
EPIC-26¹¹		×				×	×	×	×
SAS¹²		×				×	×	×	×
Weekly consumption of pads		×	×	×	×	×	×	×	×
Severity of PPI		×				×	×	×	×
Self-assessment						×	×	×	×
Blind assessment						×
Major AE of PCa¹³			×	×	×	×	×	×	×
AE¹⁴			×	×	×	×	×	×	×
SAE¹⁵			×	×	×	×	×	×	×

Notes:
¹Vital signs: blood pressure, pulse, body temperature, and respiration
²Blood routine: hemoglobin, red blood cell count, white blood cell count, lymphocyte, neutrophil, and platelet count
³Urine routine: white blood cell, red blood cell, protein, and ketone body
⁴Biochemical items: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, urea nitrogen, glomerular filtration rate, creatinine, glucose, triglyceride, total cholesterol, high-density lipoprotein, low-density lipoprotein, potassium, sodium, calcium
⁵ECG: electrocardiogram
⁶BMI: body mass index
⁷ECOG score: Eastern Cooperative Oncology Group score
⁸Personal history: including family history, smoking history, drinking history, drug and food allergy history, marriage history, occupational exposure history
⁹Physical examination: the researchers will conduct a comprehensive physical examination at baseline, including general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lung, heart, abdomen, back, lymph nodes, limbs, and nervous system examination. All other visits will have a brief physical examination, i.e., a general appearance examination
¹⁰ICIQ-UI SF: International Consultation Incontinence Questionnaire-Urinary Incontinence Short Form
¹¹EPIC-26: The Expanded Prostate Cancer Index Composite 26-item version
¹²SAS: Self-Rating Anxiety Scale is a 20-item self-report assessment
¹³Major adverse event (AE) of prostate cancer (PCa): it refers to the AEs related to the progression of PCa from the time of enrollment to the end of follow-up
¹⁴AE: It refers to the AEs caused by the intervention measures of the project from the time of admission to the end of follow-up
¹⁵SAE: It refers to the serious adverse events caused by the intervention measures of the project during the period from enrollment to the end of follow-up

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ISSN: 1745-6215

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