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Evaluation of the effect of early electroacupuncture intervention on urinary continence after radical prostatectomy: a randomized single-blind sham-electroacupuncture parallel control multi-center clinical study

Evaluation of the effect of early electroacupuncture intervention on urinary continence after radical prostatectomy: a randomized single-blind sham-electroacupuncture parallel control multi-center clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000542
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-11-04
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

prostate cancer

Interventions

shame- electro acupunture:shame- electro acupunture
electro acupuncture:electro acupuncture

Sponsors

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) patients aged 18-80 years old (including 18 and 80 years old) diagnosed with localized prostate cancer and undergoing radical prostatectomy; (2) Clinical stage of tumor =cT2bN0M0; (3) ECOG score of 0-1; (4) voluntarily participated in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) patients with preoperative detrusor overactivity urethral stricture urge urinary incontinence stress urinary incontinence and filling urinary incontinence; (2) preoperative IPSS=20; (3) patients with genitourinary infections (such as acute urethritis and acute cystitis); (4) patients with a history of pelvic radiotherapy; (5) patients with previous prostate surgery; (6) severe cardiovascular disease liver and kidney insufficiency coagulation dysfunction; (7) those with mental illness or mental disorder who cannot express themselves normally; (8) those who received acupuncture treatment one month before the study; (9) fear acupuncture feel dizzy or reject acupuncture treatment; (10) Other conditions considered by the investigator to be inappropriate for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with complete urinary control at 3 months after surgery;

Secondary

MeasureTime frame
The King's Health questionnaire (KHQ) was used to evaluate the patients at 1 3 6 and 12 months after operation;Risk factors affecting the effect of early electroacupuncture intervention on urinary continence recovery at 3 months after surgery;Median time to complete urinary control;Proportion of patients with complete urinary control at 1 6 and 12 months after surgery;International prostate symptom score (IPSS) at 1 3 6 and 12 months after surgery;Visual analogue scale (VAS) of continence at 1 3 6 and 12 months after surgery;Incontinence quality of life questionnaire (I-QOL) was used to evaluate the quality of life at 1 3 6 and 12 months after surgery;The scores of International Consultation on Incontinence Questionnaire (ICIQ-UI-SF) were evaluated at 1 3 6 and 12 months after surgery;The Quality of life questionnaire-Core 30 (QOL-C30) was evaluated at 1 3 6 and 12 months after operation;

Countries

China

Contacts

Public ContactDongliang Xu

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Dr_xudongliang@shutcm.edu.cn13918829767

Outcome results

None listed

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