Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorYanjun Zhang, Baoyan Liu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Electroacupuncture
Procedure/SurgeryIn 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 Ciliao, Zhongliao, and Sanyinjiao respectively. Continuous wave at a frequency of 2 Hz is applied, with current intensity gradually increased from 0 to a well-tolerated level (1-5 mA for Ciliao and Zhongliao; 0.5-2 mA for Sanyinjiao). Take electroacupuncture for 30 minutes per session over a 6-month period. During the first month, treatment is 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.
Sham electroacupuncture
Procedure/SurgeryIn 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 to bilateral Ciliao, Zhongliao, and Sanyinjiao respectively. Continuous wave at a frequency of 2 Hz is applied, with current intensity 0.1-0.3 mA to produce slight tingling tolerated by the patient. Stimulation is delivered for 30 seconds then turned off. Each session lasts 30 minutes over 6-month period. During the first month, treatment is 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.
Treatment groups
312 Participants
are divided into 2 treatment groupsGroup A: Electroacupuncture groupExperimental treatment 1 intervention
Group B: Sham electroacupuncture groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with no acute lower urinary tract infection
The proportion of participants who have no acute lower urinary tract infection (LUTI) episodes at the end of post-randomization 6-month was calculated.
Time frame
At the end of the post-randomization 6-monthSecondary outcomes
1
Proportion of participants with no acute lower urinary tract infection
The proportion of participants who have no acute lower urinary tract infection (LUTI) episode at the end of post-randomization 6-month was calculated.
Time frame
At the end of the post-randomization 12-month2
Mean annual number of acute lower urinary tract infections per person
This indicator was calculated using the person-year method was calculated as total number of recurrences during follow-up divided by total person-years of follow up. Total person-years were defined as the sum of each participant' s actual follow-up time from randomization to the endpoint, loss to follow-up, or study completion.
Time frame
From enrollment to the end of study at 12 months3
Total cumulative numbers of lower urinary tract infections
Total number of cumulative lower urinary tract infections in all patients within 1 year
Time frame
At the end of post-randomization 6-month and 12-month4
Distribution of cumulative number of lower urinary tract infections
The number and proportion of patients with 0, 1, 2, 3, 4, and ≥5 lower urinary tract infection episodes within 6 months and 12 months.
Time frame
At the end of post-randomization 6-month and 12-monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yanjun Zhang, Baoyan Liu
Lead sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Sponsor institution
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator
Source ClinicalTrials.gov
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