Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

Official title

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

Overview

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.

Interventions

• 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 "needl

Primary outcome measures

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

Secondary outcome measures (7)

• The percentage change in the number of voids every 24 hours. [Time frame: At week 2, week 8(follow-up) and week 16 (follow-up).]
• The mean changes of OABSS. [Time frame: 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. [Time frame: At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).]
• Overactive Bladder Questionnaire (OAB-q). [Time frame: At baseline and week 4 (end of treatment).]
• Generalized Anxiety Disorder 7 (GAD-7) [Time frame: At baseline and week 4 (end of treatment).]
• Health-Related Quality of Life (HRQoL) [Time frame: At baseline and week 4 (end of treatment).]
• Participants'self-evaluation of therapeutic effects. [Time frame: At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai

Publications

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05798403 · SHDC12022103

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗