Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial|
- Percentage of change from baseline in 72-h incontinence episode frequency (IEF) (week 12) [ Time Frame: Week 1-12 ] [ Designated as safety issue: Yes ]The average 72-h IEF is calculated based on a 72-h bladder diary. The average 72-h IEF of week1-12 is calculated by averaging the IEF of week 2, 4, 6, 8, 10, 12.
- Percentage of change from baseline in 72-h IEF [ Time Frame: Week 13-36, week 1-4, week 5-8, week 9-12, week 13-24, week 25-36 ] [ Designated as safety issue: Yes ]Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point.
- Percentage of participants with ≥50% decrease in average 72-h incontinence episode frequency [ Time Frame: Week 1-12, 13-24, 13-36 ] [ Designated as safety issue: No ]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.
- Change from baseline in 72-h incontinence episode frequency [ Time Frame: Baseline, week 1-12, 13-24, 13-36 ] [ Designated as safety issue: No ]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.
- Change from baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score [ Time Frame: Baseline, week 1-12, 13-36 ] [ Designated as safety issue: No ]The score of week 1-12 equals to the sum score of week 4, 8, 12 divided by 3.
- Change from baseline in the amount of urine leakage [ Time Frame: Baseline, week 4, week 12 ] [ Designated as safety issue: No ]The amount of urine leakage was tested by 1-h pad test.
- Change from baseline in average 72-h urgencies/urination/nocturia episodes [ Time Frame: Baseline, week 1-12, 13-36 ] [ Designated as safety issue: No ]The average 72-h urgencies/urination/nocturia episodes within a period equal to the sum of urgencies/urination/nocturia episodes (counted according to the urinary diary) divided by the number of weeks recorded.
- Change from the baseline in the number of pads used in one week [ Time Frame: Baseline, week 1-12, 13-36 ] [ Designated as safety issue: No ]The mean of pads used in one week equals to the sum of pad used in a period divided by the number of weeks within this period.
- Percentage of change from the baseline in 72-h IEF of subgroups [ Time Frame: Week 1-12, 13-36 ] [ Designated as safety issue: No ]Stratified by incontinence severity/types of mixed urinary incontinence/age at the baseline, the percentage of change in 72-h incontinence episode frequency will be analyzed.
- Satisfaction degree [ Time Frame: Week 12, 36 ] [ Designated as safety issue: No ]A questionnaire will be done by participants to evaluate whether they are satisfied with the treatment.
- Patient global impression improvement [ Time Frame: Week 12, 36 ] [ Designated as safety issue: No ]Participants will be asked to finish one item evaluating their present condition.
- Electroacupuncture acceptance assessment [ Time Frame: Treatment session 1, 18, 36 ] [ Designated as safety issue: No ]After the 1st, 18th and 36th session, 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). Mean of scores of the three times will be calculated.
|Study Start Date:||April 2014|
|Study Completion Date:||October 2016|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
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.
Other Name: electroacupuncture
Active Comparator: Solifenacin plus PFMT
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
Other Name: competitive cholinergic receptor antagonistProcedure: PFMT
Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
Other Name: pelvic floor muscle training
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02047032
|Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences|
|Beijing, China, 100053|
|Study Director:||Zhishun Liu, doctor||Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences|