Overactive Bladder
Conditions
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.
Interventions
DEVICEelectroacupuncture
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.
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.
Sponsors
Longhua Hospital
Yin Ping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Generalized Anxiety Disorder 7 (GAD-7) | At baseline and week 4 (end of treatment). | The GAD-7 is used to assess subjects' anxiety. |
| 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). |
| 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). |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | During 1-4 weeks. | Observe the incidence of adverse events during the treatment. |
| Evaluation of discomfort during treatment. | Within 5 minutes after the first, sixth and twelfth acupuncture 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. |
| Patient acceptability evaluation | Within 5 minutes after the first and ninth acupuncture treatment. | 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. |
| Blinding assessment | At the end of the 12th session of acupuncture treatment | 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. |
Countries
China
Contacts
Primary ContactPING YIN
Backup ContactYUELAI CHEN
Outcome results
None listed