Back to resultsEfficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
Solifenacin Succinate Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
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.
Sites / Locations
- Longhua Hospital Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electroacupuncture group
Solifenacin Succinate group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Generalized Anxiety Disorder 7 (GAD-7)
The GAD-7 is used to assess subjects' anxiety.
Health-Related Quality of Life (HRQoL)
The HRQoL will be measured by the King's Health Questionnaire (KHQ).
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).
Full Information
NCT ID
NCT05798403
First Posted
March 10, 2023
Last Updated
July 25, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Longhua Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05798403
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Longhua Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
During the study, except for acupuncturists, other people involved in the trial, including participants, study supervisors, efficacy evaluators, data analysts, prescription drug prescribers and statistical analysts, will all be blinded to patients group assignment.
Allocation
Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture group
Arm Type
Experimental
Arm Description
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.
Arm Title
Solifenacin Succinate group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
electroacupuncture
Other Intervention Name(s)
placebo medication
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate Tablets
Other Intervention Name(s)
Sham electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
the percentage change in the number of voids every 24 hours at week 4.
Description
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.
Time Frame
At week 4 (end of treatment).
Secondary Outcome Measure Information:
Title
The percentage change in the number of voids every 24 hours.
Description
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.
Time Frame
At week 2, week 8(follow-up) and week 16 (follow-up).
Title
The mean changes of OABSS.
Description
The OABSS assessed the occurrence of daytime voiding, nocturnal voiding, urgency and urge incontinence in patients during the last week.
Time Frame
At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).
Title
The number of urinary incontinence and urgency every 24 hours.
Description
The number of urinary incontinence and urgency every 24 hours based on a three-day voiding diary.
Time Frame
At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).
Title
Overactive Bladder Questionnaire (OAB-q).
Description
The OAB-q is an observation of the severity and frequency of bladder-related symptoms in patients over the past four weeks.
Time Frame
At baseline and week 4 (end of treatment).
Title
Generalized Anxiety Disorder 7 (GAD-7)
Description
The GAD-7 is used to assess subjects' anxiety.
Time Frame
At baseline and week 4 (end of treatment).
Title
Health-Related Quality of Life (HRQoL)
Description
The HRQoL will be measured by the King's Health Questionnaire (KHQ).
Time Frame
At baseline and week 4 (end of treatment).
Title
Participants'self-evaluation of therapeutic effects.
Description
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).
Time Frame
At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events
Description
Observe the incidence of adverse events during the treatment.
Time Frame
During 1-4 weeks.
Title
Evaluation of discomfort during treatment.
Description
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.
Time Frame
Within 5 minutes after the first, sixth and twelfth acupuncture treatment.
Title
Patient acceptability evaluation
Description
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.
Time Frame
Within 5 minutes after the first and ninth acupuncture treatment.
Title
Blinding assessment
Description
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.
Time Frame
At the end of the 12th session of acupuncture treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PING YIN
Phone
0086-18917561621
Email
bingxue616@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
YUELAI CHEN
Phone
0086-13020193726
Email
chenyuelai@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YUELAI CHEN
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Longhua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YUELAI CHEN
Phone
0086-13020193726
Email
chenyuelai@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31039103
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.
Results Reference
background
PubMed Identifier
35494662
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.
Results Reference
background
PubMed Identifier
34346046
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.
Results Reference
background
PubMed Identifier
34289514
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.
Results Reference
background
Learn more about this trial
Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder
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