Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder
ConditionOveractive Bladder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorYin Ping
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
electroacupuncture
DeviceAll 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.
Solifenacin Succinate Tablets
DrugDuring 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.
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: Electroacupuncture groupExperimental treatment 1 intervention
Group B: Solifenacin Succinate groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At week 4 (end of treatment).Secondary outcomes
1
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.
Time frame
At week 2, week 8(follow-up) and week 16 (follow-up).2
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.
Time frame
At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).3
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.
Time frame
At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).4
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.
Time frame
At baseline and week 4 (end of treatment).Other outcomes
1
Incidence of adverse events
Observe the incidence of adverse events during the treatment.
Time frame
During 1-4 weeks.2
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.
Time frame
Within 5 minutes after the first, sixth and twelfth acupuncture treatment.3
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.
Time frame
Within 5 minutes after the first and ninth acupuncture treatment.4
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.
Time frame
At the end of the 12th session of acupuncture treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yin Ping
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Sponsor institution
Longhua Hospital
Collaborator
Source ClinicalTrials.gov