Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder
NCT ID: NCT05798403
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
204 participants
INTERVENTIONAL
2023-07-07
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Longhua Hospital
OTHER
Yin Ping
OTHER
Responsible Party
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Yin Ping
Shanghai University of Traditional Chinese Medicine
Principal Investigators
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YUELAI CHEN
Role: PRINCIPAL_INVESTIGATOR
Shanghai University of Traditional Chinese Medicine
Locations
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Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
Joseph S, Maria SA, Peedicayil J. Drugs Currently Undergoing Preclinical or Clinical Trials for the Treatment of Overactive Bladder: A Review. Curr Ther Res Clin Exp. 2022 Apr 6;96:100669. doi: 10.1016/j.curtheres.2022.100669. eCollection 2022.
Mirzaei M, Daneshpajooh A, Anvari SO, Dozchizadeh S, Teimorian M. Evaluation of the Clinical Efficacy and Complications of Duloxetine in Comparison to Solifenacin in the Treatment of Overactive Bladder Disease in Women: A Randomized Clinical Trial. Urol J. 2021 Aug 3;18(5):543-548. doi: 10.22037/uj.v18i.6274.
Hargreaves E, Harding C, Clarkson C. Acupuncture in addition to standard conservative treatment for overactive bladder; a feasibility trial for a randomized controlled study. Neurourol Urodyn. 2021 Sep;40(7):1770-1779. doi: 10.1002/nau.24741. Epub 2021 Jul 21.
Chen B, Yin P, Li J, Hou W, Fan Q, Huai Y, Liu L, Hu J, Chow ST, Li X, Ming S, Chen YL. Electroacupuncture versus solifenacin succinate for female overactive bladder: study protocol for a multicentre, randomised, controlled, double-dummy, non-inferiority trial. BMJ Open. 2024 Sep 12;14(9):e076374. doi: 10.1136/bmjopen-2023-076374.
Other Identifiers
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SHDC12022103
Identifier Type: -
Identifier Source: org_study_id
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