NCT05798403

Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Yin Ping · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Through a scientific and standardized multicenter, blinding, double-dummy, randomized controlled, noninferiority clinical trial study method, the investigators evaluated electroacupuncture as a safe and effective non-pharmacological treatment for OAB in women by comparison with Solifenacin Succinate.

Detailed description

Epidemiological researches have shown that approximately 500 million people worldwide are affected by OAB, 2 3 with a higher incidence in women than that in men. Pharmacological treatment remains the usual method of clinical treatment. However, some Pharmacologphy has certain side effects, such as blurred consciousness, dry mouth, constipation, and so on, which have limited its widespread clinical use. Therefore, the treatment of OAB needs comprehensive consideration in clinical practice, which deserves our attention and active exploration of other effective treatment methods to relieve patients' pain.Electroacupuncture can effectively improve the clinical symptoms of OAB. As for the comparison between electroacupuncture and medication for the treatment of OAB in women, the results are inconclusive based on the limited research evidence. The aim of the study is to investigate the effectiveness and safety of electroacupuncture compared to Solifenacin Succinate.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	electroacupuncture	All acupuncture locations will be sterilized on a routine basis. As acupuncture needles are inserted, all needles will be lifting, twirling, and thrusting to reach de qi, a sensation generally associated with acupuncture, including swelling, soreness, numbness, and heaviness. An electrical stimulator is applied to ipsilateral BL32 and BL35 (KI12 and ST28) with continuous waves of 30 Hz and currents of 1 to 5.0 mA. During the study, oral Solifenacin Succinate placebo will be used.
DRUG	Solifenacin Succinate Tablets	During the study, participants will take Solifenacin Succinate. The acupuncture points are the same as the electroacupuncture group, without the insertion of needles. The procedures, electrode positions and other treatment settings are the same as the electroacupuncture group, without the skin penetration, power output or needle manipulation of the de qi. At the end of the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball to allow the patient to feel the "needles"being pulled out.

Timeline

• Start date: 2023-07-07
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2023-04-04
• Last updated: 2025-05-22

Locations

1 site across 1 country: China