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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004306
Enrollment
Unknown
Registered
2021-01-22
Start date
2021-03-09
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

control group:sham acupuncture
acupuncture group:acupuncture

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
ICIQ-SF;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactYingjie Jia

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

jiayingjie1616@sina.com+86 13802133132

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026