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

NCT07507851 | Not Yet Recruiting

• 1 other identifier: LCLX2026003[Z]
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 2

Brief 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. 1.Does electroacupuncture reduce the attacks of acute recurrent urinary tract infections in women?
2. 2.What medical problems do participants have when taking electroacupuncture?
3. 3.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.
4. 4.Visit the hospital at the end of the 1st, 2nd, 3rd, and 6th months for follow-up evaluations.
5. 5.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)

Outcome Measures

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.

  At the end of the post-randomization 6-month

Secondary Outcomes (20)

• Proportion of participants with no acute lower urinary tract infection

  At the end of the post-randomization 12-month

• Mean annual number of acute lower urinary tract infections per person

  From enrollment to the end of study at 12 months

• Total cumulative numbers of lower urinary tract infections

  At the end of post-randomization 6-month and 12-month

• Distribution of cumulative number of lower urinary tract infections

  At the end of post-randomization 6-month and 12-month

• Time to first acute lower urinary tract infection episode

  At the end of post-randomization 12-month

Study Arms (2)

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.

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.

Procedure: Sham electroacupuncture

Interventions

Electroacupuncture PROCEDURE

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.

Electroacupuncture group

Sham electroacupuncture PROCEDURE

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.

Sham electroacupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-75 years;
• Meeting the diagnostic criteria for recurrent lower urinary tract infections;
• No acute lower urinary tract infections at enrollment;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (2)

Guang' anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Location

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

MeSH Terms

Conditions

Urinary Tract Infections; Recurrence

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Shiyan SY Yan, Ph.D.

CONTACT

86 18330165705; wei_jiachang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A single-blind design was adopted in this study. Participants were blinded. In addition, outcome assessors and statisticians were also blinded, while acupuncture practitioners were unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (2)