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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Tract Infections; Electroacupuncture; Recurrent; Randomized Controlled Trial (RCT)
• Intervention / Treatment: Procedure: Electroacupuncture; Procedure: Sham electroacupuncture

• Study Type: Interventional
• Enrollment (Estimated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiyan SY Yan, Ph.D.; Phone Number: 86 18330165705; Email: wei_jiachang@126.com

Study Locations

• China
  • Beijing, China
    • Guang' anmen Hospital of China Academy of Chinese Medical Sciences
  • Tianjin, China
    • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Currently receiving prophylactic antibiotics for lower urinary tract infection;
2. Abnormal urinary tract anatomy (e.g., urinary calculi);
3. Complicated or neurogenic genitourinary disorders, such as spinal cord injury, cauda equina injury, active pelvic inflammatory disease, active vaginitis, overactive bladder, interstitial cystitis;
4. Requiring urinary catheterization;
5. HIV infection, long-term use of immunosuppressants, infection with multidrug-resistant organisms, or uncontrolled diabetes mellitus;
6. Pelvic organ prolapses of grade 2 or above;
7. Post-void residual urine volume > 100 ml measured by B-ultrasound;
8. Lactating, pregnant, or planning to conceive within the next 6 months;
9. Implantation of a cardiac pacemaker;
10. Malignant tumor; severe cardiac, pulmonary, cerebral, hepatic, renal, or hematological diseases, mental illness, or significant cognitive impairment;
11. Previous history of electroacupuncture treatment;
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture group; In the electroacupuncture group, Ciliao (BL32), Zhongliao (BL33), Shenshu (BL23), and Sanyinjiao (SP6) are used as the main acupoints. Adjunct acupoints are prescribed based on syndrome differentiation of accompanying symptoms. After needle insertion, the electrodes of the electroacupuncture device are connected horizontally to the needle handles of bilateral Ciliao, Zhongliao, and Sanyinjiao respectively. Continuous wave at a frequency of 2 Hz is applied. The current intensity is set at 1-5 mA for Ciliao and Zhongliao, and 0.5-2 mA for Sanyinjiao. The current is gradually increased from 0 to a level well tolerated by the patient. Take 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.	Procedure: 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 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 Comparator: Sham electroacupuncture group; In the sham electroacupuncture group, control points corresponding to Ciliao (BL32), Zhongliao (BL33), Shenshu (BL23), and Sanyinjiao (SP6) are used as the main acupoints. Adjunct acupoints are prescribed based on syndrome differentiation of accompanying symptoms. After needle insertion, the electrodes of the electroacupuncture device are connected horizontally to the needle handles of bilateral control points for Ciliao, Zhongliao, and Sanyinjiao respectively. Continuous wave at a frequency of 2 Hz is applied, with the current intensity set at 0.1-0.3 mA to produce a slight tingling sensation tolerated by the patient. The stimulation is delivered for 30 seconds and then turned off. Take 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.	Procedure: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the post-randomization 6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the post-randomization 12-month
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.	From enrollment to the end of study at 12 months
Total cumulative numbers of lower urinary tract infections	Total number of cumulative lower urinary tract infections in all patients within 1 year	At the end of post-randomization 6-month and 12-month
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.	At the end of post-randomization 6-month and 12-month
Time to first acute lower urinary tract infection episode	It was defined as the time interval from randomization to the first occurrence of acute lower urinary tract infection, recorded in days. For participants without recurrence during the follow-up period, the data were censored at the end of the study.	At the end of post-randomization 12-month
Mean interval between recurrent lower urinary tract infections	It was defined as the time interval between two consecutive episodes of acute lower urinary tract infection during the observation period, recorded and calculated in days. Patients with only one episode or no recurrence were not included in the calculation.	At the end of post-randomization 12-month
Mean duration per episode of lower urinary tract infection	It refers to the time from the onset to remission of each acute lower urinary tract infection episode, documented in days. The mean value was calculated as the average duration of all such episodes.	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	It refers to the average score of the Urinary Tract Infection Symptoms (UTIS) questionnaire completed by patients during each acute lower urinary tract infection episode, which reflects the severity of symptoms during each episode. The UTIS is used to assess the severity of urinary tract infection-related symptoms. Scores were calculated based on the frequency and severity of symptoms. UTIS comprises 4 dimensions: none, mild, moderate, and severe. Each dimension is rated on 4 levels (none = 0, mild = 1, moderate = 2, severe = 3). Lower scores indicate milder urinary symptoms and a better outcome, while higher scores indicate more severe symptoms.	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	It was defined as the difference between the urinary tract infection symptom score (UTIs) score at follow-up time points without acute lower urinary tract infection and the baseline score, used to evaluate the improvement of persistent urinary symptoms. The UTIS is used to assess the severity of urinary tract infection-related symptoms. Scores were calculated based on the frequency and severity of symptoms. UTIS comprises 4 dimensions: none, mild, moderate, and severe. Each dimension is rated on 4 levels (none = 0, mild = 1, moderate = 2, severe = 3). Lower scores indicate milder urinary symptoms and a better outcome, while higher scores indicate more severe symptoms.	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	It was defined as the difference between the EQ-5D-5L score at each follow-up time point and the baseline score, to assess the improvement in patients' quality of life. The EQ-5D-5L comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on 5 levels (1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = extreme problems). Higher scores indicate better health-related quality of life.	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	It was defined as the difference between the Hospital Anxiety and Depression Scale (HADS) total score, anxiety subscale score, and depression subscale score at each follow-up time point and the baseline score, used to evaluate the effect of the intervention on anxiety and depression. The HADS consists of two subscales: anxiety and depression, with 7 items each. Each item is scored from 0 to 3. Anxiety subscale: 0-21, depression subscale: 0-21. Higher scores indicate more severe anxiety and depression, while lower scores reflect better emotional state.	At the end of post-randomization 3-month, 6-month, and 12-month
Changes in post-void residual urine volume from baseline	It was defined as the difference between post-void residual urine volume at each follow-up time point and the baseline value, to evaluate the effect of the intervention on patients' urinary function. Post-void residual urine volume was measured by abdominal ultrasound. After the patient completely emptied the bladder, the superior-inferior, left-right, and anterior-posterior diameters of the bladder were measured, and the volume was calculated using the built-in formula of the ultrasound machine.	At the end of post-randomization 6-month, and 12-month
Changes in maximum urinary flow rate (Qmax) and average urinary flow rate (Qave) from baseline	It was defined as the difference between the maximum urinary flow rate, average urinary flow rate at each follow-up time point and the baseline values, to assess the effect of the intervention on patients' urinary function. Maximum urinary flow rate and average urinary flow rate were measured by uroflowmetry. With a natural desire to void, patients urinated freely and independently into the uroflowmeter device, which automatically recorded and calculated the maximum and average urinary flow rates in mL/s.	At the end of post-randomization 6-month, and 12-month
Percentage of participants with patient global impression of change (PGIC) rated as much improved, improved, or minimally improved	Patient-Reported Response Rate assessed by the Patient Global Impression of Change (PGIC) scale, defined as the percentage of patients with at least mild improvement (including very much improved, much improved, and minimally improved) after intervention among all valid cases. PGIC: patients rated their overall change after treatment based on subjective feelings, using a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Lower scores indicate better patient-reported response rate.	At the end of post-randomization 3-month, 6-month, 9-month, and 12-month
Patient expectation of acupuncture outcome	Patients' expectation of the therapeutic effect of acupuncture was assessed using a questionnaire before treatment. Patients were asked: "In general, how do you think your lower urinary tract infection will be 6 months from now?" The response options included: much better, better, do not know, no change, and worse.	At the end of post-randomization baseline and 3-month
Patient trust in acupuncture assessment	Patients' trust in acupuncture therapy was assessed using a questionnaire before treatment. Patients were asked: "Do you think acupuncture is helpful for treating your lower urinary tract infection?" The response options included: ineffective, poorly effective, uncertain, moderately effective, and highly effective. This index was used to evaluate patients' trust in acupuncture for urinary tract infection.	At the end of post-randomization baseline
Patient blinding assessment	After treatment, patients were asked: "Do you think the treatment you received was indistinguishable, electroacupuncture, or sham electroacupuncture?" The response options were: do not know, electroacupuncture, and sham electroacupuncture. This was used to assess patients' guesses regarding treatment allocation and to evaluate the success of blinding.	At end of post-randomization 3-month
Duration of antibiotic use per single episode of lower urinary tract infection	It refers to the actual number of days of antibiotic treatment during each acute lower urinary tract infection (LUTI) episode	At the end of post-randomization 6-month and 12-month
Percentage of patients with any cumulative antibiotic use	It refers to the proportion of enrolled patients who received at least one course of antibiotic treatment during the entire observation follow-up period.	At the end of post-randomization 6-month and 12-month
Cumulative days of antibiotic use	It refers to the cumulative number of days of antibiotic treatment received by each participant during the entire follow-up observation period.	At the end of post-randomization 6-month and 12-month

Collaborators and Investigators

• Sponsor: Yanjun Zhang, Baoyan Liu
• Collaborators: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Pathological Conditions, Signs and Symptoms; Recurrence; Urinary Tract Infections; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Combined Modality Therapy; Anesthesia; Analgesia; Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Electroacupuncture
• Other Study ID Numbers: LCLX2026003[Z]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No