Urinary Incontinence
Conditions
Keywords
electroacupuncture, urinary incontinence, PFMT, Solifenacin
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREacupuncture
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.
DRUGsolifenacin
Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PROCEDUREPFMT
Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* females meet the meet the diagnostic criteria of mixed urinary incontinence * aged 35-75 years * moderate and severe urinary incontinence with the urinary incontinence severity index between 3 and 9 * suffering from urinary incontinence at least for 3 months with the 72-h incontinence episode frequency≥2 in the baseline assessment * voluntarily join the research and sign the informed consent
Exclusion criteria
* pure stress urinary incontinence, pure urgency urinary incontinence, overflow incontinence and neurogenic bladder * medicine use for urinary incontinence or may affect the bladder function, or taking any non-drug therapy (such as electric stimulation, bladder training and pelvic floor muscle training) in the last month * symptomatic urinary tract infection and non-functional urologic disease * having ever undergone an operation for urinary incontinence or on the pelvic floor (including hysterectomy) * pelvic organ prolapse degree ≥2 * residual urinary volume (RUV) \>30 mL * maximum flow rate (Qmax) \<20 mL/s; * be allergic to solifenacin or having contradictions for muscarine antagonist (such as urinary retention, gastric retention, myasthenia gravis, ulcerative colitis and angle closure glaucoma) * diseases affect function of lower urinary tract, such as uncontrolled diabetes, multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal injury, cauda equina injury and multiple system atrophy. * serious cardiovascular, pulmonary, cerebral, liver, kidney, hematopoietic system or psychiatric disease and cognitive impairment * patients with severe renal dysfunction or moderate hepatic dysfunction who are using strong Cyp3a4 Inhibitor like ketoconazole * unable or limited to walking, up and down stairs and running * poor compliance with electroacupuncture, pelvic floor muscle training or drug * pregnancy, lactation or within the 12 months after birth * having a cardiac pacemaker, a metal allergy, or a severe needle phobia. * volunteer of other trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency | 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 | 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 | 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 | 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 | 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). |
| Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 | 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. |
| Patient Global Impression Improvement | Weeks 12, 36 | Participants will be asked to finish one item evaluating their present condition. |
| Electroacupuncture Acceptance Assessment | 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 | Weeks 1-12, 13-24, 25-36 | — |
| Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | Weeks 1-12, 13-24, 25-36 | — |
| Patient's Treatment Satisfaction Degree | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture 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).
acupuncture: 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. | 250 |
| 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: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE). | 250 |
| Total | 500 |
Baseline characteristics
| Characteristic | Acupuncture | Solifenacin Plus PFMT | Total |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 10.11 | 53.7 years STANDARD_DEVIATION 9.38 | 54.2 years STANDARD_DEVIATION 9.75 |
| Sex: Female, Male Female | 250 Participants | 250 Participants | 500 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 250 | 90 / 250 |
| serious Total, serious adverse events | 0 / 250 | 1 / 250 |
Outcome results
Primary
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
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Solifenacin Plus PFMT | Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 | -36.49 percent change |
| Electroacupuncture | Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 | -37.83 percent change |
Secondary
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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Solifenacin Plus PFMT | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score | Week 12 | -3.96 units on a scale |
| Solifenacin Plus PFMT | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score | Week 24 | -6.44 units on a scale |
| Solifenacin Plus PFMT | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score | Week 36 | -7.06 units on a scale |
| Electroacupuncture | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score | Week 12 | -3.73 units on a scale |
| Electroacupuncture | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score | Week 24 | -5.97 units on a scale |
| Electroacupuncture | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score | Week 36 | -6.80 units on a scale |
Secondary
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
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urgence, Weeks 13-24 | -4.75 percent change |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urgence, Weeks 25-36 | -5.55 percent change |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urination, Weeks 1-12 | -3.23 percent change |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urination, Weeks 13-24 | -5.96 percent change |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urination, Weeks 25-36 | -7.02 percent change |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h nocturia, Weeks 1-12 | -0.79 percent change |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h nocturia, Weeks 13-24 | -1.38 percent change |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h nocturia, Weeks 25-36 | -1.58 percent change |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urgence, Weeks 1-12 | -2.62 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h nocturia, Weeks 25-36 | -1.58 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urgence, Weeks 1-12 | -2.99 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urgence, Weeks 13-24 | -4.77 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urination, Weeks 25-36 | -6.11 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urgence, Weeks 25-36 | -5.55 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h nocturia, Weeks 13-24 | -1.33 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urination, Weeks 1-12 | -3.62 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h nocturia, Weeks 1-12 | -0.87 percent change |
| Electroacupuncture | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | Change in the 72-h urination, Weeks 13-24 | -5.26 percent change |
Secondary
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Time frame: Weeks 1-12, 13-24, 25-36
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | Weeks 1-12 | -4.56 episodes |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | Weeks 13-24 | -7.27 episodes |
| Solifenacin Plus PFMT | Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | Weeks 25-36 | -8.31 episodes |
| Electroacupuncture | Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | Weeks 1-12 | -4.37 episodes |
| Electroacupuncture | Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | Weeks 13-24 | -6.95 episodes |
| Electroacupuncture | Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | Weeks 25-36 | -8.22 episodes |
Secondary
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
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Solifenacin Plus PFMT | Electroacupuncture Acceptance Assessment | Week 2 | 3.0 units on a scale |
| Solifenacin Plus PFMT | Electroacupuncture Acceptance Assessment | Week 6 | 3.0 units on a scale |
| Solifenacin Plus PFMT | Electroacupuncture Acceptance Assessment | Week 12 | 3.0 units on a scale |
Secondary
Patient Global Impression Improvement
Participants will be asked to finish one item evaluating their present condition.
Time frame: Weeks 12, 36
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 36 | No change | 9 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 12 | Marked worening | 0 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 12 | Moderate improvement | 85 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 36 | Marked improvement | 87 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 12 | Moderate worsening | 0 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 36 | Moderate improvement | 93 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 12 | Slight improvement | 82 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 36 | Slight improvement | 55 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 36 | Slight worsening | 1 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 12 | No change | 8 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 36 | Moderate worsening | 0 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 12 | Marked improvement | 69 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 36 | Marked worening | 0 Participants |
| Solifenacin Plus PFMT | Patient Global Impression Improvement | Week 12 | Slight worsening | 0 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 36 | Marked worening | 0 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 36 | No change | 9 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 12 | Marked improvement | 52 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 12 | Moderate improvement | 75 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 12 | Slight improvement | 96 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 12 | No change | 8 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 12 | Moderate worsening | 0 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 12 | Marked worening | 0 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 36 | Marked improvement | 74 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 36 | Moderate improvement | 92 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 36 | Slight improvement | 59 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 36 | Slight worsening | 1 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 36 | Moderate worsening | 0 Participants |
| Electroacupuncture | Patient Global Impression Improvement | Week 12 | Slight worsening | 3 Participants |
Secondary
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
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment. 2 refused to participate and did not receive PFMT-solifenacin treatment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 12 | No change | 80 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 12 | Marked dissatisfaction | 0 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 36 | Marked satisfaction | 77 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 12 | Satisfaction | 84 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 36 | Satisfaction | 90 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 12 | Dissatisfaction | 12 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 36 | No change | 58 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 36 | Dissatisfaction | 9 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 12 | Marked satisfaction | 58 Participants |
| Solifenacin Plus PFMT | Patient's Treatment Satisfaction Degree | Week 36 | Marked dissatisfaction | 0 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 12 | Dissatisfaction | 12 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 36 | Marked dissatisfaction | 0 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 12 | Marked satisfaction | 62 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 12 | Satisfaction | 112 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 12 | No change | 56 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 36 | No change | 47 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 12 | Marked dissatisfaction | 1 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 36 | Marked satisfaction | 85 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 36 | Satisfaction | 101 Participants |
| Electroacupuncture | Patient's Treatment Satisfaction Degree | Week 36 | Dissatisfaction | 11 Participants |
Secondary
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
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Solifenacin Plus PFMT | Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 | Weeks 13-24 | -58.20 percent change |
| Solifenacin Plus PFMT | Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 | Weeks 25-36 | -64.20 percent change |
| Electroacupuncture | Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 | Weeks 13-24 | -56.69 percent change |
| Electroacupuncture | Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 | Weeks 25-36 | -65.48 percent change |
Secondary
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
Population: For various reasons, participants discontinued study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Solifenacin Plus PFMT | Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency | Weeks 1-12 | 109 Participants |
| Solifenacin Plus PFMT | Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency | Weeks 13-24 | 174 Participants |
| Solifenacin Plus PFMT | Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency | Weeks 25-36 | 190 Participants |
| Electroacupuncture | Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency | Weeks 1-12 | 112 Participants |
| Electroacupuncture | Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency | Weeks 13-24 | 164 Participants |
| Electroacupuncture | Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency | Weeks 25-36 | 188 Participants |
Secondary
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
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Solifenacin Plus PFMT | the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12 | Week 4 | -6.74 amount of leakage (grams) |
| Solifenacin Plus PFMT | the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12 | Week 12 | -12.16 amount of leakage (grams) |
| Electroacupuncture | the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12 | Week 4 | -6.96 amount of leakage (grams) |
| Electroacupuncture | the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12 | Week 12 | -11.49 amount of leakage (grams) |
Secondary
The Number of Participants Using Urine Pads
Time frame: Weeks 1-12, 13-24, 25-36
Population: For various reasons, the participants discontinued study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Solifenacin Plus PFMT | The Number of Participants Using Urine Pads | Weeks 25-36 | 59 Participants |
| Solifenacin Plus PFMT | The Number of Participants Using Urine Pads | Weeks 1-12 | 86 Participants |
| Solifenacin Plus PFMT | The Number of Participants Using Urine Pads | Weeks 13-24 | 68 Participants |
| Electroacupuncture | The Number of Participants Using Urine Pads | Weeks 13-24 | 80 Participants |
| Electroacupuncture | The Number of Participants Using Urine Pads | Weeks 25-36 | 72 Participants |
| Electroacupuncture | The Number of Participants Using Urine Pads | Weeks 1-12 | 105 Participants |
Secondary
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
Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Solifenacin Plus PFMT | Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 | Weeks 1-12 | 8.0 urine pads |
| Solifenacin Plus PFMT | Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 | Weeks 13-24 | 7.0 urine pads |
| Solifenacin Plus PFMT | Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 | Weeks 25-36 | 8.0 urine pads |
| Electroacupuncture | Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 | Weeks 1-12 | 9.0 urine pads |
| Electroacupuncture | Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 | Weeks 13-24 | 8.0 urine pads |
| Electroacupuncture | Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 | Weeks 25-36 | 8.0 urine pads |