EA for BPS: an RCT and Study for Central Mechanism

Launched by THE THIRD AFFILIATED HOSPITAL OF ZHEJIANG CHINESE MEDICAL UNIVERSITY · Mar 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of electroacupuncture (a type of acupuncture that uses electrical stimulation) for treating Bladder Pain Syndrome (BPS). Participants will be randomly assigned to one of three groups: one group will receive medication, another group will receive electroacupuncture, and the third group will undergo a sham acupuncture procedure that doesn’t involve real treatment. The trial is open to adults aged 18 to 70 who experience moderate to severe pain related to BPS. However, individuals with certain health issues, such as severe heart or kidney diseases, or those who are pregnant or have recently participated in other trials, are not eligible to join.

Participants can expect to receive treatment for four weeks, followed by a four-week follow-up period. Throughout the trial, their symptoms, like pain and how often they need to urinate, will be carefully assessed. The researchers aim to determine if electroacupuncture can help improve these symptoms compared to medication. It's important to note that while the acupuncturists and participants will know which treatment they are receiving, the people assessing the outcomes will not, helping to maintain the objectivity of the results.

Gender

ALL

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.