Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence

Last updated: February 2, 2022
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT03787654
2018-163-KY
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female patients diagnosed with mixed urinary incontinence in accordance with EAUguideline 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 episodesis urgency one in 72-hour voiding diary;
  6. Positive cough test;
  7. A voluntarily-signed written informed content.

Exclusion

Exclusion Criteria:

  1. Having pure stress urinary incontinence, pure urgency urinary incontinence, overflowurinary 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 antimuscarinicdrug 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 asMultiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, caudaequina nerve injury and multiple system atrophy;
  11. Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosologyand coagulation function, or obvious cognitive disability;
  12. Installed a cardiac pacemaker;
  13. Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinaryretention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerativecolitis, 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 afterdelivery.

Study Design

Total Participants: 282
Study Start date:
March 01, 2019
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Guang An Men Hospital

    Beijing, 100053
    China

    Active - Recruiting

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