Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT02047032|
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Procedure: acupuncture Drug: solifenacin Procedure: PFMT||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||October 2016|
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 antagonist
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
- Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 [ Time Frame: baseline, 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)
- Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 [ Time Frame: baseline, weeks 13-24, week 25-36 ]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: Weeks 1-12, 13-24, 25-36 ]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 of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes [ Time Frame: Baseline, weeks 1-12, 13-24, 25-36 ]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, weeks 12, 24 and 36 ]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.
- 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 [ Time Frame: 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).
- Patient's Treatment Satisfaction Degree [ Time Frame: Weeks 12, 36 ]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.
- Patient Global Impression Improvement [ Time Frame: Weeks 12, 36 ]Participants will be asked to finish one item evaluating their present condition.
- Electroacupuncture Acceptance Assessment [ Time Frame: Weeks 2, 6 and 12 ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|