Comparing electroacupuncture and medication for treating overactive bladder in women

Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder: A Multicenter, Randomized, Controlled, Noninferiority Trial

This study is testing whether electroacupuncture can help women with overactive bladder feel better compared to the medication Solifenacin.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai University of Traditional Chinese Medicine (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05798403 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of electroacupuncture as a non-pharmacological treatment for overactive bladder (OAB) in women, comparing it to the medication Solifenacin Succinate. The study employs a multicenter, double-dummy, randomized controlled design to ensure rigorous assessment of both treatment methods. By focusing on women aged 18-75 with a diagnosis of OAB, the trial aims to provide insights into the safety and effectiveness of electroacupuncture, especially given the side effects associated with traditional pharmacological treatments. The results will help determine if electroacupuncture can serve as a viable alternative for managing OAB symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18-75 who have been diagnosed with overactive bladder for at least three months and have not previously received acupuncture treatment.

Not a fit: Patients with severe underlying health conditions or those who have undergone pelvic organ surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a safe and effective non-drug treatment option for women suffering from overactive bladder.

How similar studies have performed: While there is limited research on the comparison of electroacupuncture and medication for OAB, previous studies have shown promising results for electroacupuncture in treating similar conditions.

Eligibility criteria

Inclusion Criteria:

* Meet the American Urological Association (AUA) diagnostic criteria for adult overactive bladder disorder (non-neurogenic) and the Chinese Urological Association's Guidelines for the Diagnosis and Treatment of Urological Diseases in China (2014 edition) for OAB.
* Female patients aged 18-75 years.
* Duration of illness with OAB ≥ 3 months.
* 3≤OABSS≤11.
* No abnormality in routine urine tests.
* Patients had never received acupuncture treatment.
* No mental or intellectual abnormalities, able to understand the provisions of the scales and complete the assessment.
* Consent to participate in this study and sign a written informed consent.

Exclusion Criteria:

* Combination of more serious heart, liver, kidney and other serious diseases; Or patients with severe liver or kidney insufficiency.
* Patients with pelvic organ prolapse ≥ Ⅱ degree, urinary system surgery history or pelvic floor surgery history.
* Patients with other diseases presenting with OAB symptoms.
* Those with urinary diseases (such as calculi and tuberculosis of the bladder), malignant tumors, and neurological disorders.
* Patients who are pregnant or breastfeeding.
* Patients using medication that may affect bladder function one month prior to enrollment or having received behavioural therapy for OAB three months prior to enrolment, etc.
* Patients with pacemakers.
* Patients with blood diseases, diabetes mellitus or mental diseases.
* Infections, ulcers, abscesses, and skin infections at needling sites; metal allergy or extreme needle phobia.
* Participation in other clinical medical trial studies over the last month.

Where this trial is running

Shanghai, Shanghai Municipality

• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: YUELAI CHEN — Shanghai University of Traditional Chinese Medicine
• Study coordinator: PING YIN

Conditions: Overactive Bladder