Acupuncture for Urinary Incontinence in Patients With Prostate Cancer Surgery: a Multicenter, Single-Blinded, Randomized, Parallel-Controlled Trial

Not Applicable

Recruiting

• Conditions: Prostate cancer

• Registration Number: ITMCTR2100004306
• Lead Sponsor: The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria for prostate cancer;
2. Meet the diagnostic criteria for urinary incontinence (1), (2), (3), (4);
3. Karnofsky score >= 60 points or ECOG 0-1 points;
4. Aged >= 18 years;
5. Sign informed consent.

Exclusion Criteria

1.Urgent urinary incontinence caused by detrusor hyperreflexia and bladder spasm, and urinary incontinence caused by central or endocrine factors;
2.Urinary incontinence was treated after cystostomy, reconstruction of urethral sphincter, suspension of urethra and other treatments;
3.Receiving treatment methods similar to acupuncture treatment principles (such as electroacupuncture, warm moxibustion, warm acupuncture, etc.) at present or within six months;
4.Complete urinary incontinence after prostate cancer surgery, that is, surgery to damage the pudendal nerve, complete loss of external urethral sphincter function through urodynamic test;
5.People with urinary tract infection (except those with asymptomatic lower urinary tract infection);
6.Known severe arrhythmia, severe cardiac insufficiency, acute myocarditis, constrictive pericarditis, pericardial tamponade, severe valvular disease, heart failure and other serious heart diseases;
7.Known liver injury or potentially serious liver disease (ALT or AST > 10 times normal);
8.Known severe renal function impairment (eGFR < 25mL/min/1.73m2), or planned or in dialysis, or acute contrast nephropathy at the time of screening;
9.Known other important organ dysfunction or severe primary diseases such as hematopoietic system;
10.Known coagulation dysfunction (with typical clinical diagnosis or clear laboratory test results);
11.Patients with mental illness or cognitive impairment, severe depression, alcohol dependence and drug abuse history;
12.In addition to prostate cancer surgery, patients with urinary incontinence due to other reasons;
13.According to the judgment of the researcher, those who are not suitable to participate in this research, or have factors that are likely to fall out of the group, such as frequent changes in the work environment, which may easily cause loss to follow-up;
14.According to the researcher's judgment, the survival period may be <= 6 months;
15.Participating in other clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICIQ-SF;

Secondary Outcome Measures

Name	Time	Method
1-hour pad test;EPIC-26;Weekly consumption of pads;Severity of urinary incontinence;Self-Rating Anxiety Scale;Self-report assessment of therapeutic effect;72-hour voiding diary;