Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02047032
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 16.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Procedure: acupuncture; Drug: solifenacin; Procedure: PFMT	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Procedure: 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.; Other Names: 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.	Drug: solifenacin; Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 ); Other Names: competitive cholinergic receptor antagonist ; Procedure: PFMT; Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).; Other Names: pelvic floor muscle training

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 [Baseline, weeks 1-12, 13-24, 25-36]

6. 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).

7. 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.

8. Patient Global Impression Improvement [Weeks 12, 36]

   Participants will be asked to finish one item evaluating their present condition.

9. 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.

10. The Number of Participants Using Urine Pads [Weeks 1-12, 13-24, 25-36]

11. Change of Episodes From Baseline in Mean 72-h Incontinence Episodes [Weeks 1-12, 13-24, 25-36]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences	Beijing		China	100053

Sponsors and Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

• Study Director: Zhishun Liu, doctor, Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• ClinicalTrials.gov Identifier: NCT02047032
• Other Study ID Numbers: 2012BAI24B01-MUI
• First Posted: Jan 28, 2014
• Last Update Posted: Jun 6, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Liu Zhishun, Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences: electroacupuncture; urinary incontinence; PFMT; Solifenacin
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Solifenacin Succinate; Cholinergic Antagonists

Study Results

Participant Flow

Arm/Group Title	Acupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Period Title: Overall Study
STARTED	250	250
COMPLETED	245	235
NOT COMPLETED	5	15

Baseline Characteristics

Arm/Group Title	Acupuncture	Solifenacin Plus PFMT	Total
Arm/Group Description	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.	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).	Total of all reporting groups
Overall Participants	250	250	500
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.7 (10.11)	53.7 (9.38)	54.2 (9.75)
Sex: Female, Male (Count of Participants)
Female	250 100%	250 100%	500 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
Description	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

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.

Arm/Group Title	Solifenacin Plus PFMT	Electroacupuncture
Arm/Group Description	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).	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.
Measure Participants	248	249
Least Squares Mean (95% Confidence Interval) [percent change]	-36.49	-37.83

2. Secondary Outcome

Title	Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
Description	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

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Weeks 13-24	-58.20	-56.69
Weeks 25-36	-64.20	-65.48

3. Secondary Outcome

Title	Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Description	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

Outcome Measure Data

Analysis Population Description

For various reasons, participants discontinued study.

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Weeks 1-12	109 43.6%	112 44.8%
Weeks 13-24	174 69.6%	164 65.6%
Weeks 25-36	190 76%	188 75.2%

4. Secondary Outcome

Title	Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Description	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

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Change in the 72-h urgence, Weeks 1-12	-2.62	-2.99
Change in the 72-h urgence, Weeks 13-24	-4.75	-4.77
Change in the 72-h urgence, Weeks 25-36	-5.55	-5.55
Change in the 72-h urination, Weeks 1-12	-3.23	-3.62
Change in the 72-h urination, Weeks 13-24	-5.96	-5.26
Change in the 72-h urination, Weeks 25-36	-7.02	-6.11
Change in the 72-h nocturia, Weeks 1-12	-0.79	-0.87
Change in the 72-h nocturia, Weeks 13-24	-1.38	-1.33
Change in the 72-h nocturia, Weeks 25-36	-1.58	-1.58

5. Secondary Outcome

Title	Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Week 12	-3.96	-3.73
Week 24	-6.44	-5.97
Week 36	-7.06	-6.80

6. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Weeks 1-12	8.0	9.0
Weeks 13-24	7.0	8.0
Weeks 25-36	8.0	8.0

7. Secondary Outcome

Title	the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
Description	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

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Week 4	-6.74	-6.96
Week 12	-12.16	-11.49

8. Secondary Outcome

Title	Patient's Treatment Satisfaction Degree
Description	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

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment. 2 refused to participate and did not receive PFMT-solifenacin treatment.

Arm/Group Title	Solifenacin Plus PFMT	Electroacupuncture
Arm/Group Description	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).	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.
Measure Participants	248	249
Marked satisfaction	58 23.2%	62 24.8%
Satisfaction	84 33.6%	112 44.8%
No change	80 32%	56 22.4%
Dissatisfaction	12 4.8%	12 4.8%
Marked dissatisfaction	0 0%	1 0.4%
Marked satisfaction	77 30.8%	85 34%
Satisfaction	90 36%	101 40.4%
No change	58 23.2%	47 18.8%
Dissatisfaction	9 3.6%	11 4.4%
Marked dissatisfaction	0 0%	0 0%

9. Secondary Outcome

Title	Patient Global Impression Improvement
Description	Participants will be asked to finish one item evaluating their present condition.
Time Frame	Weeks 12, 36

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Marked improvement	69 27.6%	52 20.8%
Moderate improvement	85 34%	75 30%
Slight improvement	82 32.8%	96 38.4%
No change	8 3.2%	8 3.2%
Slight worsening	0 0%	3 1.2%
Moderate worsening	0 0%	0 0%
Marked worening	0 0%	0 0%
Marked improvement	87 34.8%	74 29.6%
Moderate improvement	93 37.2%	92 36.8%
Slight improvement	55 22%	59 23.6%
No change	9 3.6%	9 3.6%
Slight worsening	1 0.4%	1 0.4%
Moderate worsening	0 0%	0 0%
Marked worening	0 0%	0 0%

10. Secondary Outcome

Title	Electroacupuncture Acceptance Assessment
Description	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

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment.

Arm/Group Title	Electroacupuncture
Arm/Group Description	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.
Measure Participants	249
Week 2	3.0
Week 6	3.0
Week 12	3.0

11. Secondary Outcome

Title	The Number of Participants Using Urine Pads
Time Frame	Weeks 1-12, 13-24, 25-36

Outcome Measure Data

Analysis Population Description

For various reasons, the participants discontinued study.

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Weeks 1-12	86 34.4%	105 42%
Weeks 13-24	68 27.2%	80 32%
Weeks 25-36	59 23.6%	72 28.8%

12. Secondary Outcome

Title	Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Time Frame	Weeks 1-12, 13-24, 25-36

Outcome Measure Data

Analysis Population Description

1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.

Arm/Group Title	Electroacupuncture	Solifenacin Plus PFMT
Arm/Group Description	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.	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).
Measure Participants	249	248
Weeks 1-12	-4.56	-4.37
Weeks 13-24	-7.27	-6.95
Weeks 25-36	-8.31	-8.22

Adverse Events

Arm/Group Title	Electroacupuncture		Solifenacin Plus PFMT
Arm/Group Description	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.		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).
All Cause Mortality
	Electroacupuncture		Solifenacin Plus PFMT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Electroacupuncture		Solifenacin Plus PFMT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/250 (0%)		1/250 (0.4%)
Injury, poisoning and procedural complications
Fracture	0/250 (0%)	0	1/250 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Electroacupuncture		Solifenacin Plus PFMT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/250 (16.4%)		90/250 (36%)
Eye disorders
dry eye	0/250 (0%)	0	1/250 (0.4%)	1
Gastrointestinal disorders
Dry mouth	0/250 (0%)	0	62/250 (24.8%)	62
constipation	0/250 (0%)	0	7/250 (2.8%)	7
stomach	1/250 (0.4%)	1	6/250 (2.4%)	6
diarrhea	3/250 (1.2%)	3	2/250 (0.8%)	2
dyspepsia	0/250 (0%)	0	5/250 (2%)	5
heartburn	0/250 (0%)	0	1/250 (0.4%)	1
Injury, poisoning and procedural complications
subcutaneous hematoma	10/250 (4%)	10	0/250 (0%)	0
Nervous system disorders
dizziness	2/250 (0.8%)	2	2/250 (0.8%)	2
hypogeusia	0/250 (0%)	0	2/250 (0.8%)	2
blurred vision	0/250 (0%)	0	1/250 (0.4%)	1
headache	1/250 (0.4%)	1	0/250 (0%)	0
herpes zoster	1/250 (0.4%)	1	0/250 (0%)	0
low back pain	0/250 (0%)	0	1/250 (0.4%)	1
pruritus	0/250 (0%)	0	1/250 (0.4%)	1
urinary tract infection	2/250 (0.8%)	2	0/250 (0%)	0
dysuria	0/250 (0%)	0	1/250 (0.4%)	1
Reproductive system and breast disorders
upper respiratory infection	19/250 (7.6%)	19	10/250 (4%)	10
Respiratory, thoracic and mediastinal disorders
cough	1/250 (0.4%)	1	1/250 (0.4%)	1
Skin and subcutaneous tissue disorders
facial edema	1/250 (0.4%)	1	0/250 (0%)	0

Limitations/Caveats

The noninferiority margin to PFMT-solifenacin in MUI women was hard to define. PFMT were led by trained research assistants instead of professional therapists, which may dilute the effect of the control group.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.