Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Treatments: Solifenacin Succinate

Criteria

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.