Clinical trial NCT03787654: Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence
Official title: Effect of Electroacupuncture for Women With Urgency-predominant Mixed Urinary Incontinence: a Three Armed Non-inferior Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mixed Urinary Incontinence
Urgency-predominant Mixed Urinary Incontinence
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 282
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.
timeFrame: week 12
Secondary outcomes:
measure: Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.
timeFrame: week 4, week 8, week 24, week 36
measure: Change of urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Proportion of subjects with at least 50% reduce of urgency urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Proportion of subjects with complete resolution of urgency urinary incontinence episodes in average 24 hours based on 3-day voiding diary.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Proportion of subjects with at least 50% reduce of urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Change of voiding episodes in average 24 hours from baseline based on 3-day voiding diary.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Change of voiding episodes graded as 3/4 in average 24 hours from baseline based on the Patient Perception of Intensity of Urgency Scale( PPIUS).
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Change of nocturia episodes in average 24 hours from baseline based on 3-day voiding diary.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Change of pad consuming in average 24 hours from baseline based on 3-day voiding diary.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: volume change of water intake in average 24 hours from baseline based on 3-day voiding diary.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Change of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF ) score from baseline.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Change of Overactive bladder questionnaire short form (OABq-SF) score from baseline.
timeFrame: week 4, week 8, week 12, week 24, week 36
measure: Proportion of subjects with adequate improvement assessed by Patient global impression improvement (PGI-I).
timeFrame: week 12, week 36
measure: Change of residual urinary volume from baseline tested by abdominal B-ultrasound.
timeFrame: week 12
Other outcomes:
measure: Proportion of subjects bearing expectancy towards acupuncture AND proportion of subjects bearing expectancy towards drugs.
timeFrame: baseline
measure: Proportion of subjects successfully blinded
timeFrame: week 12
measure: Incidence of adverse events
timeFrame: week 0-36
Locations:
city: Beijing
country: China
facility: Guang An Men Hospital
Study officials:
affiliation: Guanganmen Hospital
name: Zhishun Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun Y, Liu Y, Su T, Sun J, Wu Y, Liu Z. Electroacupuncture versus solifenacin for women with urgency-predominant mixed urinary incontinence: a protocol for a three-armed non-inferiority randomized controlled trial. BMC Complement Med Ther. 2020 Jan 23;20(1):18. doi: 10.1186/s12906-019-2784-1.