Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

Not Applicable

Recruiting

• Conditions: Overactive Bladder
• Interventions: Device: electroacupuncture; Drug: Solifenacin Succinate Tablets

• Registration Number: NCT05798403
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-04
• Study Start: 2023-07-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture group	electroacupuncture	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.
Solifenacin Succinate group	Solifenacin Succinate Tablets	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.

Primary Outcome Measures

Name	Time	Method
the percentage change in the number of voids every 24 hours at week 4.	At week 4 (end of treatment).	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.

Secondary Outcome Measures

Name	Time	Method
The percentage change in the number of voids every 24 hours.	At week 2, week 8(follow-up) and week 16 (follow-up).	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.
The mean changes of OABSS.	At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).	The OABSS assessed the occurrence of daytime voiding, nocturnal voiding, urgency and urge incontinence in patients during the last week.
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).	The number of urinary incontinence and urgency every 24 hours based on a three-day voiding diary.
Participants'self-evaluation of therapeutic effects.	At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).	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).
Generalized Anxiety Disorder 7 (GAD-7)	At baseline and week 4 (end of treatment).	The GAD-7 is used to assess subjects' anxiety.
Overactive Bladder Questionnaire (OAB-q).	At baseline and week 4 (end of treatment).	The OAB-q is an observation of the severity and frequency of bladder-related symptoms in patients over the past four weeks.
Health-Related Quality of Life (HRQoL)	At baseline and week 4 (end of treatment).	The HRQoL will be measured by the King's Health Questionnaire (KHQ).

Trial Locations

Locations (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China