Evaluating electroacupuncture for bladder pain syndrome

Electroacupuncture for Bladder Pain Syndrome: An Randomized Controlled Trial and Study for Central Mechanism

This study is testing if electroacupuncture can help people with bladder pain syndrome feel better compared to medication and a fake treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05279963 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the efficacy and safety of electroacupuncture in treating bladder pain syndrome (BPS) through a randomized controlled design. Participants will be randomly assigned to one of three groups: medication, electroacupuncture, or sham acupuncture, with a 1:2:1 allocation ratio. The study will involve a 4-week treatment phase followed by a 4-week follow-up, during which outcomes will be evaluated at multiple time points. The trial will utilize fMRI to analyze brain activity related to symptom relief, while ensuring blinding for outcome assessors and statisticians to minimize bias.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who meet specific diagnostic criteria for bladder pain syndrome and have moderate to severe pain levels.

Not a fit: Patients with significant organic lesions or severe primary diseases, as well as those who cannot undergo electroacupuncture, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-pharmacological treatment option for patients suffering from bladder pain syndrome.

How similar studies have performed: While acupuncture has been studied for various conditions, this specific approach using electroacupuncture for bladder pain syndrome is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 18 ≤ age ≤70 years, male or female;
* Must fulfill the first and the second diagnostic criteria;
* 30 mm≤ VAS score ≤80mm;
* Participants can fully understand the study protocol and a written informed consent is signed.

Exclusion Criteria:

* Patients with previous bladder stones or other space-occupying lesions;
* Previous positive urine culture or significant abnormal urine routine;
* Significant organic lesions of genitourinary system and pelvic organs;
* Patients suffer from severe primary diseases such as cardiovascular, cerebrovascular, respiratory, liver and kidney, or patients cannot receive EA treatment due to any reasons;
* People with heart stents and other metallic substances in their bodies;
* Women who are pregnant, planning to become pregnant, breast-feeding or allergic to study drugs;
* Patients have participated in other clinical trials within the last 3 months.

Where this trial is running

Hangzhou, Zhejiang

• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Yuanyuan Wu, PHD

Conditions: Bladder Pain Syndrome, electroacupuncture, Randomized Controlled Trial, multi-modal magnetic resonance imaging