Find Urinary Incontinence Clinical Trials Near You
Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder: A Multicenter, Randomized, Controlled, Noninferiority Trial
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
RECRUITING
Shanghai
Contact Information
Primary
PING YIN
bingxue616@163.com
0086-18917561621
Backup
YUELAI CHEN
chenyuelai@163.com
0086-13020193726
Time Frame
Start Date:2023-07-07
Estimated Completion Date:2025-12-31
Participants
Target number of participants:204
Treatments
Experimental: Electroacupuncture group
Participants will receive electroacupuncture treatment at Shenshu (BL23), Ciliao (BL32), Zhonglvshu (BL29), Huiyang (BL35), Weizhong (BL40), Zhongji (CV3), Dahe (KI12), Shuidao (ST28), Sanyinjiao (SP6). It should be noted that CV3, KI12, ST28, SP6 are used as the group A acupoints and BL23, BL32, BL29, BL35, BL40 as the group B acupoints. Patients will be treated with alternating group A and B acupoints. The frequency of treatment is 3 times a week and each treatment will last for 30 minutes for a total of 12 sessions over the course of four weeks. The follow-up observation will be recorded on week 8 and 16.~At the same time, participants will also receive placebo medication. Oral Solifenacin Succinate placebo will be used and taken once a day for 4 weeks.
Active_comparator: Solifenacin Succinate group
Participants will take Solifenacin Succinate (Wuhan Human well Puracap (Likang) Pharmaceuticals Co., Ltd.) orally before breakfast for 4 consecutive weeks at 5 mg (1 tablet) per day.~At the same time, the participants will receive sham electroacupuncture with a pragmatic placebo needle on sham acupoints. Participants will have the same needle retention time, treatment time, and follow-up time as the electroacupuncture group.