The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence

Not Applicable

Recruiting

• Conditions: Postprostatectomy Incontinence
• Interventions: Device: Electrical Acupuncture Stimulation; Device: sham Acupuncture

• Registration Number: NCT04972669
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-22
• Status Verified: 2024-11
• Primary Completion: 2024-12-20
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Study Completion: 2025-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Electrical Acupuncture Stimulation	Electroaupuncture
control group	sham Acupuncture	sham electroaupuncture

Primary Outcome Measures

Name	Time	Method
Continence rate after 6 weeks of treatment	3 years

Secondary Outcome Measures

Name	Time	Method
change of urine pad quantity for 24 hours after 4 courses compared with baseline	3 years
change of weight in kilograms of urine pad for 24 hours after 6 courses compared with baseline	3 years
changes of The expanded prostate cancer index composite(EPIC) score after 4-6 courses compared with baseline	3 years
Long-term urinary continence recovery	3 year	time from randomization to urinary continence

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China