Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

NCT05798403 | Recruiting DMC

• 1 other identifier: SHDC12022103
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• the percentage change in the number of voids every 24 hours at week 4.

  The percentage change in the number of voids every 24 hours at week 4 compared to baseline. It is measured by a three-day voiding diary.

  At week 4 (end of treatment).

Secondary Outcomes (7)

• The percentage change in the number of voids every 24 hours.

  At week 2, week 8(follow-up) and week 16 (follow-up).

• The mean changes of OABSS.

  At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).

• The number of urinary incontinence and urgency every 24 hours.

  At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).

• Overactive Bladder Questionnaire (OAB-q).

  At baseline and week 4 (end of treatment).

• Generalized Anxiety Disorder 7 (GAD-7)

  At baseline and week 4 (end of treatment).

Other Outcomes (4)

• Incidence of adverse events

  During 1-4 weeks.

• Evaluation of discomfort during treatment.

  Within 5 minutes after the first, sixth and twelfth acupuncture treatment.

• Patient acceptability evaluation

  Within 5 minutes after the first and ninth acupuncture treatment.

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

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.

Device: electroacupuncture

Solifenacin Succinate group

ACTIVE COMPARATOR

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.

Drug: Solifenacin Succinate Tablets

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.

Also known as: placebo medication

Electroacupuncture group

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.

Also known as: Sham electroacupuncture

Solifenacin Succinate group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yin Ping: lead
• Longhua Hospital: collaborator

Study Sites (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 31039103 BACKGROUND

• 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.

  PMID: 35494662 BACKGROUND

• 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.

  PMID: 34346046 BACKGROUND

• 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.

  PMID: 34289514 BACKGROUND

• 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.

  PMID: 39266323 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Electroacupuncture; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• YUELAI CHEN

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PING YIN

CONTACT

0086-18917561621; bingxue616@163.com

YUELAI CHEN

CONTACT

0086-13020193726; chenyuelai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the study, except for acupuncturists, other people involved in the trial, including participants, study supervisors, efficacy evaluators, data analysts, prescription drug prescribers and statistical analysts, will all be blinded to patients group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 4, 2023
• Study Start: July 7, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)