The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence

Nanjing University

Status: Enrolling

Conditions: Postprostatectomy Incontinence

Treatments: Device: Electrical Acupuncture Stimulation; Device: sham Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04972669

IUNU-PC-105

Details and patient eligibility

About

More than 50% patients underwent prostatectomy suffered from postoperative incontinence, and the effect of pelvic floor muscle training is very limited. Electrical acupuncture stimulation therapy has been demonstrated to work on other kinds of Urinary Incontinence. Before this trial, the researchers have conducted pre-experiments where electrical acupuncture stimulation therapy was conducted for few postprostatectomy Incontinence patients. On the basis of the preliminary work, this prospective, random control research aims to verify the safety and effectiveness of electroacupuncture in the treatment of postprostatectomy Incontinence.

Enrollment: 110 estimated patients

Sex: Male

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• localized prostate cancer (stage: cT1-cT2, N0, M0)
• 4-6weeks after prostatectomy
• postprostatectomy prostate specific antigen (PSA) test below cured level
• incontinence one month after surgery
• ECOG score:0-1

Exclusion criteria

• history of neoadjuvant hormonal therapy
• history of transurethral resection of the prostate (TUPR)
• history of operation on pelvis
• history of incontinence before prostatectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

control group

Sham Comparator group

Description:

sham electroaupuncture

Treatment:

Device: sham Acupuncture

experimental group

Experimental group

Description:

Electroaupuncture

Treatment:

Device: Electrical Acupuncture Stimulation