Urinary Tract InfectionsrLUTINCT07507851
Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women
A study testing Electroacupuncture in people with Urinary Tract Infections and Recurrent, run by Yanjun Zhang, Baoyan Liu at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Tract Infections, Recurrent, Electroacupuncture
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Guang' anmen Hospital of China Academy of Chinese Medical Sciences
Beijing
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
About this study
Official title: 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:
- Does electroacupuncture reduce the attacks of acute recurrent urinary tract infections in women?
- What medical problems do participants have when taking electroacupuncture?
Read more
Researchers will compare electroacupuncture to sham electroacupuncture to assess if electroacupuncture works to prevent recurrent lower urinary tract infections.
Participants will:
- 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.
- Visit the hospital at the end of the 1st, 2nd, 3rd, and 6th months for follow-up evaluations.
- Keep a diary of their symptoms and the number of times they use an antibiotic.
- Conditions
- Urinary Tract Infections, Recurrent, Electroacupuncture, Randomized Controlled Trial (RCT)
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Medical subject headings
- Urinary Tract Infections, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
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 electroacupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | 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. Receives: Procedure: Electroacupuncture |
| Sham electroacupuncture group | Sham comparator | 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. Receives: Procedure: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the post-randomization 6-month
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At the end of post-randomization 6-month and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanjun Zhang, Baoyan Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor-investigator, Yanjun Zhang, Baoyan Liu, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507851
- Sponsor's protocol ID
- LCLX2026003[Z]
- Acronym
- rLUTI
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women
- ClinicalTrials.gov ID
- NCT07507851
- Acronym / sponsor ID
- rLUTI / LCLX2026003[Z]
- Conditions
- Urinary Tract Infections, Recurrent, Electroacupuncture, Randomized Controlled Trial (RCT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Yanjun Zhang, Baoyan LiuUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does electroacupuncture reduce the attacks of acute recurrent urinary tract infections in women?
- 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:
- 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.
- Visit the hospital at the end of the 1st, 2nd, 3rd, and 6th months for follow-up evaluations.
- Keep a diary of their symptoms and the number of times they use an antibiotic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Procedure: ElectroacupunctureIn 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. |
| Sham electroacupuncture group | Sham comparator | Procedure: Sham electroacupunctureIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureIn 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. | Procedure or surgery | Electroacupuncture group |
| Sham electroacupunctureIn 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. | Procedure or surgery | Sham electroacupuncture group |
Primary outcome
Proportion of participants with no acute lower urinary tract infection
Time frame: At the end of the post-randomization 6-month
The proportion of participants who have no acute lower urinary tract infection (LUTI) episodes at the end of post-randomization 6-month was calculated.
20 secondary outcomes
Proportion of participants with no acute lower urinary tract infection
Time frame: At the end of the post-randomization 12-month
Mean annual number of acute lower urinary tract infections per person
Time frame: From enrollment to the end of study at 12 months
Total cumulative numbers of lower urinary tract infections
Time frame: At the end of post-randomization 6-month and 12-month
Distribution of cumulative number of lower urinary tract infections
Time frame: At the end of post-randomization 6-month and 12-month
Time to first acute lower urinary tract infection episode
Time frame: At the end of post-randomization 12-month
Mean interval between recurrent lower urinary tract infections
Time frame: At the end of post-randomization 12-month
Mean duration per episode of lower urinary tract infection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the end of post-randomization 3-month, 6-month, and 12-month
Changes in post-void residual urine volume from baseline
Time frame: 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
Time frame: 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
Time frame: At the end of post-randomization 3-month, 6-month, 9-month, and 12-month
Patient expectation of acupuncture outcome
Time frame: At the end of post-randomization baseline and 3-month
Patient trust in acupuncture assessment
Time frame: At the end of post-randomization baseline
Patient blinding assessment
Time frame: At end of post-randomization 3-month
Duration of antibiotic use per single episode of lower urinary tract infection
Time frame: At the end of post-randomization 6-month and 12-month
Percentage of patients with any cumulative antibiotic use
Time frame: At the end of post-randomization 6-month and 12-month
Cumulative days of antibiotic use
Time frame: At the end of post-randomization 6-month and 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Urinary Tract Infections and Recurrent, run by Yanjun Zhang, Baoyan Liu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyan SY Yan, Ph.D. (86 18330165705, wei_jiachang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with no acute lower urinary tract infection (time frame: At the end of the post-randomization 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.