Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798403
• Other study ID #: SHDC12022103
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: PING YIN
• Phone: 0086-18917561621
• Email: bingxue616[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 = ? 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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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 "needles"being pulled out.

Locations

Country	Name	City	State
China	Longhua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	Observe the incidence of adverse events during the treatment.	During 1-4 weeks.
Other	Evaluation of discomfort during treatment.	Visual analog scale (VAS) will be used to evaluate the degree of discomfort during treatment. The scale ranging from 0 to 10cm, with 0cm indicating no discomfort and 10cm indicating severe discomfort. Evaluation time: The average value of the first and ninth acupuncture treatments was taken within 5 minutes after the end of the two treatments. If the VAS value is missing in one of the cases, another is taken as the result.	Within 5 minutes after the first, sixth and twelfth acupuncture treatment.
Other	Patient acceptability evaluation	0=very difficult to accept, 1=slightly difficult to accept, 2=acceptable, 3=easy to accept, 4=very easy to accept. Evaluation time: The average value of the first and ninth acupuncture treatments was taken within 5 minutes after the end of the two treatments. If the VAS value is missing in one of the cases, another is taken as the result.	Within 5 minutes after the first and ninth acupuncture treatment.
Other	Blinding assessment	Six options will be offered by an independent assessor in an interrogative manner: electroacupuncture, sham electroacupuncture and indeterminate; medication, placebo treatment and indeterminate. The patients' answers will be statistically analyzed to assess the success of the blinded implementation.	At the end of the 12th session of acupuncture treatment
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Generalized Anxiety Disorder 7 (GAD-7)	The GAD-7 is used to assess subjects' anxiety.	At baseline and week 4 (end of treatment).
Secondary	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).
Secondary	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).