Clinical trial NCT05798403: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2023-04-04
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: the percentage change in the number of voids every 24 hours at week 4.
timeFrame: At week 4 (end of treatment).
Secondary outcomes:
measure: The percentage change in the number of voids every 24 hours.
timeFrame: At week 2, week 8(follow-up) and week 16 (follow-up).
measure: The mean changes of OABSS.
timeFrame: At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).
measure: The number of urinary incontinence and urgency every 24 hours.
timeFrame: At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).
measure: Overactive Bladder Questionnaire (OAB-q).
timeFrame: At baseline and week 4 (end of treatment).
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: At baseline and week 4 (end of treatment).
measure: Health-Related Quality of Life (HRQoL)
timeFrame: At baseline and week 4 (end of treatment).
measure: Participants'self-evaluation of therapeutic effects.
timeFrame: At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).
Other outcomes:
measure: Incidence of adverse events
timeFrame: During 1-4 weeks.
measure: Evaluation of discomfort during treatment.
timeFrame: Within 5 minutes after the first, sixth and twelfth acupuncture treatment.
measure: Patient acceptability evaluation
timeFrame: Within 5 minutes after the first and ninth acupuncture treatment.
measure: Blinding assessment
timeFrame: At the end of the 12th session of acupuncture treatment
Locations:
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: YUELAI CHEN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.