Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women

Официальное название

A Randomized Controlled Trial of Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women

Обзор

The goal of this clinical trial is to evaluate if electroacupuncture works to prevent recurrent lower urinary tract infections in female patients. It will also learn about the safety of electroacupuncture. The main questions it aims to answer are: 1. Does electroacupuncture reduce the attacks of acute recurrent urinary tract infections in women? 2. What medical problems do participants have when taking electroacupuncture? Researchers will compare electroacupuncture to sham electroacupuncture to assess if electroacupuncture works to prevent recurrent lower urinary tract infections. Participants will: 1. Take electroacupuncture or sham electroacupuncture for 30 minutes per session over a 6-month period. During the first month, treatment was administered 3 times weekly (once every other day); the second month, 2 times weekly (once every 2-3 days); and the 3-6 month, once monthly. 2. Visit the hospital at the end of the 1st, 2nd, 3rd, and 6th months for follow-up evaluations. 3. Keep a diary of their symptoms and the number of times they use an antibiotic.

Вмешательства

• Процедура Electroacupuncture
  In the electroacupuncture group, Hwato brand disposable sterile acupuncture needles (Suzhou Medical Appliance Factory) with specifications of φ0.30×25mm, φ0.30×40mm, and φ0.30×75mm are used. The electroacupuncture apparatus is Hwato SDZ-V. Ciliao (BL32), Zhongliao (BL33), Shenshu (BL23), and Sanyinjiao (SP6) as main acupoints, with adjunct points selected based on syndrome differentiation. After needle insertion, electrodes of the electroacupuncture device are connected horizontally to bilateral
• Процедура Sham electroacupuncture
  In the sham electroacupuncture group, Hwato brand disposable sterile acupuncture needles (Suzhou Medical Appliance Factory) of φ0.30×25mm and φ0.30×40mm are used. The electroacupuncture apparatus is Hwato SDZ-V. Control points corresponding to Ciliao (BL32), Zhongliao (BL33), Shenshu (BL23), and Sanyinjiao (SP6) as main acupoints, with with adjunct control points selected by syndrome differentiation. After needle insertion, electrodes of the electroacupuncture device are connected horizontally t

Первичные конечные точки

• Proportion of participants with no acute lower urinary tract infection [Срок оценки: At the end of the post-randomization 6-month]

Вторичные конечные точки (12)

• Proportion of participants with no acute lower urinary tract infection [Срок оценки: At the end of the post-randomization 12-month]
• Mean annual number of acute lower urinary tract infections per person [Срок оценки: From enrollment to the end of study at 12 months]
• Total cumulative numbers of lower urinary tract infections [Срок оценки: At the end of post-randomization 6-month and 12-month]
• Distribution of cumulative number of lower urinary tract infections [Срок оценки: At the end of post-randomization 6-month and 12-month]
• Time to first acute lower urinary tract infection episode [Срок оценки: At the end of post-randomization 12-month]
• Mean interval between recurrent lower urinary tract infections [Срок оценки: At the end of post-randomization 12-month]
• Mean duration per episode of lower urinary tract infection [Срок оценки: At the end of post-randomization 6-month and 12-month]
• Mean urinary tract infection symptom score (UTIs) score per acute episode of lower urinary tract infection [Срок оценки: At each acute lower urinary tract infection episode during the entire 12-month study period]
• Changes in urinary tract infection symptom score (UTIs) score from baseline [Срок оценки: At the end of post-randomization 3-month, 6-month, 9-month, and 12-month while no acute attacks]
• Changes in EuroQol 5-Dimension 5-Level (EQ-5D-5L) score from baseline [Срок оценки: At the end of post-randomization 3-month, 6-month, and 12-month]
• Changes in total and subscale scores of the hospital anxiety and depression scale (HADS) from baseline [Срок оценки: At the end of post-randomization 3-month, 6-month, and 12-month]
• Changes in post-void residual urine volume from baseline [Срок оценки: At the end of post-randomization 6-month, and 12-month]

Критерии участия

Критерии включения

• Female patients aged 18-75 years;
• Meeting the diagnostic criteria for recurrent lower urinary tract infections;
• No acute lower urinary tract infections at enrollment;
• Voluntary participation in this trial and signed informed consent. Only patients who meet all the above inclusion criteria can be enrolled in the study.

Критерии исключения

• Currently receiving prophylactic antibiotics for lower urinary tract infection;
• Abnormal urinary tract anatomy (e.g., urinary calculi);
• Complicated or neurogenic genitourinary disorders, such as spinal cord injury, cauda equina injury, active pelvic inflammatory disease, active vaginitis, overactive bladder, interstitial cystitis;
• Requiring urinary catheterization;
• HIV infection, long-term use of immunosuppressants, infection with multidrug-resistant organisms, or uncontrolled diabetes mellitus;
• Pelvic organ prolapses of grade 2 or above;
• Post-void residual urine volume > 100 ml measured by B-ultrasound;
• Lactating, pregnant, or planning to conceive within the next 6 months;
• Implantation of a cardiac pacemaker;
• Malignant tumor; severe cardiac, pulmonary, cerebral, hepatic, renal, or hematological diseases, mental illness, or significant cognitive impairment;
• Previous history of electroacupuncture treatment;
• Subjects with potential poor compliance (e.g., living far from the hospital). Patients meeting any of the above exclusion criteria shall not be enrolled in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• Guang' anmen Hospital of China Academy of Chinese Medical Sciences — Пекин
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Тяньцзинь

Идентификаторы

NCT: NCT07507851 · LCLX2026003[Z]

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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