The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence
NCT ID: NCT04972669
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2021-03-01
2025-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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control group
sham electroaupuncture
sham Acupuncture
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.
experimental group
Electroaupuncture
Electrical Acupuncture Stimulation
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.
Interventions
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Electrical Acupuncture Stimulation
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.
sham Acupuncture
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.
Eligibility Criteria
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Inclusion Criteria
* 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 transurethral resection of the prostate (TUPR)
* history of operation on pelvis
* history of incontinence before prostatectomy
75 Years
MALE
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Hongqian Guo
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Locations
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Niu J, Wang Y, Wang Y, Shi J, Liang J, Zhao X, Xu T, Guo H, Qiu X. Electroacupuncture in Patients With Early Urinary Incontinence After Radical Prostatectomy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2534491. doi: 10.1001/jamanetworkopen.2025.34491.
Other Identifiers
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IUNU-PC-105
Identifier Type: -
Identifier Source: org_study_id
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