The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence

Conditions
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Postprostatectomy Incontinence

Intervention / Treatment
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* Device: Electrical Acupuncture Stimulation
* Device: sham Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control group<br>sham electroaupuncture | Device: sham Acupuncture<br>* Participants received sham acupuncture at locations one inch besides bilateral Baliao without needle insertion. Electrodes from the electroacupuncture apparatus were attached transversely to the needle handles. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 2-15 Hz. Participants received 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.<br>|
| Experimental: experimental group<br>Electroaupuncture | Device: Electrical Acupuncture Stimulation<br>* Participants received acupuncture at bilateral Baliao. After skin disinfection, sterile adhesive pads were placed on bilateral Baliao, and acupuncture needles were inserted through the adhesive pads. Following needle insertion, small, equal manipulations of twirling, lifting, and thrusting were performed on all needles to reach de qi. Electrodes from the electroacupuncture apparatus were attached transversely to the needle handles. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 2-15 Hz. Participants received 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of urine pad quantity for 24 hours after 6 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |