A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).
Participants experiencing mixed urinary incontinence will be recruited from 10 centers. A gynecologist or urologist will make the diagnosis. Central randomization will be performed by the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences in Beijing. Sample size: Sample size is based on the primary outcome. According to literature, the investigators predict that MUI patient's average 72-h incontinence episode frequency of the week 1-12 will decrease by 60% from the baseline after treatment of PFMT plus solifenacin. The number of the acupuncture group is 57%. For the assessment of noninferiority, 250 participants will be needed for each group allowing for a 15% dropout (α=0.05，β=0.2，δ=15%). Quality control: A 3-level monitoring system (monitors responsible for one center, monitors responsible for all centers and monitors responsible for the whole trial) will be established to check the performance of the trial in time. Outcome assessment, completion of case report forms and data management will be under strict supervision. Data management: The Remote Dara Capture (RDC) system will be used for data entering. Both paper and electronic case report form will be reserved. A data verification plan is made.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Beijing, China
Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)
Time frame: baseline, weeks 1-12
Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point.
Time frame: baseline, weeks 13-24, week 25-36
Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline.
Time frame: Weeks 1-12, 13-24, 25-36
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6.
Time frame: Baseline, weeks 1-12, 13-24, 25-36
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF (range, 0 \[best\]-21 \[worst\] outcomes, and 2.52 as minimal clinically important differences (MCID)) scores.
Time frame: baseline, weeks 12, 24 and 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
Time frame: Baseline, weeks 1-12, 13-24, 25-36
the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
The performance of 1-hour pad test according to the International Incontinence Society: Participants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820).
Time frame: Weeks 4 and 12
Patient's Treatment Satisfaction Degree
The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 \[unsatisfied strongly\] to 5 \[satisfied strongly\]) will be finished by participants to evaluate their satisfaction for the treatment.
Time frame: Weeks 12, 36
Patient Global Impression Improvement
Participants will be asked to finish one item evaluating their present condition.
Time frame: Weeks 12, 36
Electroacupuncture Acceptance Assessment
The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated.
Time frame: Weeks 2, 6 and 12
The Number of Participants Using Urine Pads
Time frame: Weeks 1-12, 13-24, 25-36
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Time frame: Weeks 1-12, 13-24, 25-36