Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence (EASE-UMUI)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Urgency-predominant Mixed Urinary Incontinence; Mixed Urinary Incontinence

Treatments: Device: electroacupuncture; Drug: Solifenacin; Device: sham electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03787654

2018-163-KY

Details and patient eligibility

About

The study is to determine the effect of electroacupuncture in female patients with urgency-predominant mixed urinary incontinence. A three-arm non-inferior randomized controlled trial (RCT) using electroacupuncture, sham electroacupuncture and solifenacin with a total sample of 282 is proposed.

The hypothesis is that the improvement (difference in number of urgency urinary incontinence episodes between baseline and 12-week evaluation) in the electroacupuncture group would be 50% or less of the difference in the improvement between the Solifenacin and the sham electroacupuncture groups.

Full description

Mixed urinary incontinence (MUI) features complaint or involuntary loss of urine associated with urgency and also with effort or physical exertion or on sneezing or coughing. It is regarded as urgency-predominant mixed urinary incontinence (UMUI) when sudden sensation of voiding accompanied by uncontrolled incontinence domains the symptoms. UMUI can bring shame and inconvenience to patients.

As first-line medicine for urge-predominant urinary incontinence, Solifenacin can reduce urgency urinary incontinence episodes in 24 hours. However, the side effects tend to bring about poor compliance among patients.

Acupuncture might be effective in treating UMUI. Previous research indicated that electroacupuncture might be noninferior to pelvic floor muscle training plus Solifenacin in reducing the urgency incontinence episodes of UMUI women. However, that study didn't focuse on UMUI exclusively, thus unable to decide whether electroacupuncture is effective in the treatment of UMUI.

Enrollment: 282 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients diagnosed with mixed urinary incontinence in accordance with EAU guideline by history intaking and physical examination[8];
2. Age between 18 and 80 years old;
3. Urgency index greater than stress index by MESA questionnaire[12];
4. At least 4 episodes of urgency urinary incontinence in 72-hour voiding diary;
5. With MUI for at least 3 months, and more than 50% of the total incontinence episodes is urgency one in 72-hour voiding diary;
6. Positive cough test;
7. A voluntarily-signed written informed content.

Exclusion criteria

1. Having pure stress urinary incontinence, pure urgency urinary incontinence, overflow urinary incontinence or neurogenic bladder;
2. Uncontrolled urinary tract infection;
3. Tumor in urinary system or pelvic organs;
4. Pelvic organ prolapse≥degreeⅡ;
5. Residual urine volume≥100ml;
6. Maximum flow rate<15ml/s;
7. Treated incontinence by acupuncture or positive medications, such as antimuscarinic drug within the past 1 month;
8. Underwent surgery of anti-incontinence or in pelvic area, metrectomy included;
9. Complication of uncontrolled diabetes and severe hypertension;
10. Complicated diseases in nerves system that could hamper hypourethral function, such as Multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, cauda equina nerve injury and multiple system atrophy;
11. Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability;
12. Installed a cardiac pacemaker;
13. Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis, angle-closure glaucoma;
14. Allergic to metal or intolerant to the stimulation of electroacupuncture;
15. Already with child or plan to conceive in the future 1 year, or within 1 year after delivery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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282 participants in 3 patient groups

electroacupuncture group

Experimental group

Description:

Acupoints of bilateral Zhongliao (BL33), Huiyang (BL35) and Sanyinjiao (SP6) are stimulated by Huatuo Brand disposable needles and SDZ-V electronic apparatus.

Treatment:

Device: electroacupuncture

sham electroacupuncture group

Sham Comparator group

Description:

Sham acupoints 1 cun(≈15mm) horizontally outwardly lateral to BL33 and BL35, and 0.5 cun(≈10mm) horizontally behind SP6 are stimulated superficially with a small electricity current by needles of 0.30×40mm size and SDZ-V electronic apparatus.

Treatment:

Device: sham electroacupuncture

Solifenacin group

Active Comparator group

Description:

subjects will orally take Solifenacin 5-10mg per day.

Treatment:

Drug: Solifenacin