Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: electroacupuncture
* Drug: Solifenacin Succinate Tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture group<br>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<br>* 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.<br>* Other names: placebo medication;|
| Active Comparator: Solifenacin Succinate group<br>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<br>* 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 needlesbeing pulled out.<br>* Other names: Sham electroacupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage change in the number of voids every 24 hours. | The percentage change in the number of voids every 24 hours at 2th, 8th and 16th weeks of the trail.It is measured by a three-day voiding diary. | At week 2, week 8(follow-up) and week 16 (follow-up). | 
| The mean changes of OABSS. | The OABSS assessed the occurrence of daytime voiding, nocturnal voiding, urgency and urge incontinence in patients during the last week. | 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. | The number of urinary incontinence and urgency every 24 hours based on a three-day voiding diary. | At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up). | 
| Overactive Bladder Questionnaire (OAB-q). | The OAB-q is an observation of the severity and frequency of bladder-related symptoms in patients over the past four weeks. | At baseline and week 4 (end of treatment). | 
| Generalized Anxiety Disorder 7 (GAD-7) | The GAD-7 is used to assess subjects' anxiety. | At baseline and week 4 (end of treatment). | 
| Health-Related Quality of Life (HRQoL) | The HRQoL will be measured by the King's Health Questionnaire (KHQ). | At baseline and week 4 (end of treatment). | 
| Participants'self-evaluation of therapeutic effects. | It will be evaluated using a four-point scale, which is level 0 (not at all helpful), level 1 (a little helpful), level 2 (moderately helpful) and level 3 (very helpful). | At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up). |