Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

Sponsor
Yin Ping
Study ID
NCT05798403
Status
Recruiting
Apply to this trial

Conditions

  • Overactive Bladder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • electroacupuncture — DEVICE
    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.
  • Solifenacin Succinate Tablets — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 4, 2023
Start date
Jul 7, 2023
Status verified
May 2025
Primary completion
Aug 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

the percentage change in the number of voids every 24 hours at week 4. [ Time Frame: At week 4 (end of treatment). ]

Central Contacts

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