The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

• Continence rate after 6 weeks of treatment [Срок оценки: 3 years]

Вторичные конечные точки (4)

• change of urine pad quantity for 24 hours after 4 courses compared with baseline [Срок оценки: 3 years]
• change of weight in kilograms of urine pad for 24 hours after 6 courses compared with baseline [Срок оценки: 3 years]
• changes of The expanded prostate cancer index composite(EPIC) score after 4-6 courses compared with baseline [Срок оценки: 3 years]
• Long-term urinary continence recovery [Срок оценки: 3 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Нанкин

Публикации

• 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. PMID 41026492

Идентификаторы

NCT: NCT04972669 · IUNU-PC-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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