CompletedNCT02047032Updated Jun 6, 2019Results posted

Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence

An interventional study of acupuncture and solifenacin in Urinary Incontinence, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Completed at 1 site in China. Open to female participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-06.

Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 500
Allocation: Randomized
Ages: 35 Years to 75 Years
Sex: Female

Study 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).

Read the 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.

Conditions studied

Urinary Incontinence

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Keywords

electroacupuncture
urinary incontinence
PFMT
Solifenacin

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 500 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 133 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 75 Years
Sexes eligible: 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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 500 participants (actual)

Study arms

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
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 · Procedure: PFMT

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.
Also known as: electroacupuncture
Drugsolifenacin
Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
Also known as: competitive cholinergic receptor antagonist
ProcedurePFMT
Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
Also known as: pelvic floor muscle training

What researchers measure

Primary outcomes

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

Secondary outcomes

Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point.
Time frame: baseline, weeks 13-24, week 25-36
Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline.
Time frame: Weeks 1-12, 13-24, 25-36
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6.
Time frame: Baseline, weeks 1-12, 13-24, 25-36
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF (range, 0 \[best\]-21 \[worst\] outcomes, and 2.52 as minimal clinically important differences (MCID)) scores.
Time frame: baseline, weeks 12, 24 and 36
Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
Time frame: Baseline, weeks 1-12, 13-24, 25-36
the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
The performance of 1-hour pad test according to the International Incontinence Society: Participants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820).
Time frame: Weeks 4 and 12
Patient's Treatment Satisfaction Degree
The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 \[unsatisfied strongly\] to 5 \[satisfied strongly\]) will be finished by participants to evaluate their satisfaction for the treatment.
Time frame: Weeks 12, 36
Patient Global Impression Improvement
Participants will be asked to finish one item evaluating their present condition.
Time frame: Weeks 12, 36
Electroacupuncture Acceptance Assessment
The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated.
Time frame: Weeks 2, 6 and 12
The Number of Participants Using Urine Pads
Time frame: Weeks 1-12, 13-24, 25-36
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Time frame: Weeks 1-12, 13-24, 25-36

Results

Posted Jun 6, 2019

Limitations and 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.

Participant flow

Participant flow — Overall Study
Milestone	Acupuncture	Solifenacin Plus PFMT
Started	250	250
Completed	245	235
Not completed	5	15

Outcome measures

PrimaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
percent change	Solifenacin Plus PFMT	Electroacupuncture
Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12	-36.49 (-43.87 to -29.11)	-37.83 (-41.96 to 33.70)

SecondaryPercentage 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
Reported as:: Least squares mean · percent change

Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
percent change	Electroacupuncture	Solifenacin Plus PFMT
Weeks 13-24	-58.20 (-63.19 to -53.22)	-56.69 (-61.77 to -51.61)
Weeks 25-36	-64.20 (-68.77 to -59.63)	-65.48 (-70.14 to -60.82)

SecondaryPercentage 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
Reported as:: Count of participants · Participants

Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Participants	Electroacupuncture	Solifenacin Plus PFMT
Weeks 1-12	109	112
Weeks 13-24	174	164
Weeks 25-36	190	188

SecondaryChange 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
Reported as:: Least squares mean · percent change

Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
percent change	Electroacupuncture	Solifenacin Plus PFMT
Change in the 72-h urgence, Weeks 1-12	-2.62 (-3.20 to -2.05)	-2.99 (-3.58 to -2.41)
Change in the 72-h urgence, Weeks 13-24	-4.75 (-5.32 to -4.19)	-4.77 (-5.35 to -4.19)
Change in the 72-h urgence, Weeks 25-36	-5.55 (-6.12 to -4.97)	-5.55 (-6.14 to -4.96)
Change in the 72-h urination, Weeks 1-12	-3.23 (-3.93 to -2.53)	-3.62 (-4.33 to -2.91)
Change in the 72-h urination, Weeks 13-24	-5.96 (-6.70 to -5.22)	-5.26 (-6.02 to -4.51)
Change in the 72-h urination, Weeks 25-36	-7.02 (-7.85 to -6.19)	-6.11 (-6.96 to -5.26)
Change in the 72-h nocturia, Weeks 1-12	-0.79 (-1.01 to -0.50)	-0.87 (-1.08 to -0.65)
Change in the 72-h nocturia, Weeks 13-24	-1.38 (-1.60 to -1.15)	-1.33 (-1.56 to -1.11)
Change in the 72-h nocturia, Weeks 25-36	-1.58 (-1.79 to -1.36)	-1.58 (-1.80 to -1.36)

SecondaryChange 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
Reported as:: Least squares mean · units on a scale

Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
units on a scale	Electroacupuncture	Solifenacin Plus PFMT
Week 12	-3.96 (-4.32 to -3.61)	-3.73 (-4.09 to -3.37)
Week 24	-6.44 (-6.90 to -5.98)	-5.97 (-6.44 to -5.50)
Week 36	-7.06 (-7.51 to -6.60)	-6.80 (-7.26 to -6.34)

SecondaryWeekly 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
Reported as:: Median · urine pads

Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
urine pads	Electroacupuncture	Solifenacin Plus PFMT
Weeks 1-12	8.0 (5.0 to 11.0)	9.0 (5.0 to 12.0)
Weeks 13-24	7.0 (4.0 to 10.0)	8.0 (5.0 to 12.0)
Weeks 25-36	8.0 (4.0 to 10.0)	8.0 (5.0 to 12.0)

Secondarythe 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
Reported as:: Least squares mean · amount of leakage (grams)

the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
amount of leakage (grams)	Electroacupuncture	Solifenacin Plus PFMT
Week 4	-6.74 (-7.93 to -5.56)	-6.96 (-8.17 to -5.76)
Week 12	-12.16 (-13.18 to -11.15)	-11.49 (-12.52 to -10.46)

SecondaryPatient'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
Reported as:: Count of participants · Participants

Patient's Treatment Satisfaction Degree
Participants	Solifenacin Plus PFMT	Electroacupuncture
Week 12 — Marked satisfaction	58	62
Week 12 — Satisfaction	84	112
Week 12 — No change	80	56
Week 12 — Dissatisfaction	12	12
Week 12 — Marked dissatisfaction	0	1
Week 36 — Marked satisfaction	77	85
Week 36 — Satisfaction	90	101
Week 36 — No change	58	47
Week 36 — Dissatisfaction	9	11
Week 36 — Marked dissatisfaction	0	0

SecondaryPatient Global Impression Improvement

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

Time frame:: Weeks 12, 36
Reported as:: Count of participants · Participants

Patient Global Impression Improvement
Participants	Electroacupuncture	Solifenacin Plus PFMT
Week 12 — Marked improvement	69	52
Week 12 — Moderate improvement	85	75
Week 12 — Slight improvement	82	96
Week 12 — No change	8	8
Week 12 — Slight worsening	0	3
Week 12 — Moderate worsening	0	0
Week 12 — Marked worening	0	0
Week 36 — Marked improvement	87	74
Week 36 — Moderate improvement	93	92
Week 36 — Slight improvement	55	59
Week 36 — No change	9	9
Week 36 — Slight worsening	1	1
Week 36 — Moderate worsening	0	0
Week 36 — Marked worening	0	0

SecondaryElectroacupuncture 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
Reported as:: Median · units on a scale

Electroacupuncture Acceptance Assessment
units on a scale	Electroacupuncture
Week 2	3.0 (3.0 to 3.0)
Week 6	3.0 (2.0 to 3.0)
Week 12	3.0 (2.0 to 3.0)

SecondaryThe Number of Participants Using Urine Pads

Time frame:: Weeks 1-12, 13-24, 25-36
Reported as:: Count of participants · Participants

The Number of Participants Using Urine Pads
Participants	Electroacupuncture	Solifenacin Plus PFMT
Weeks 1-12	86	105
Weeks 13-24	68	80
Weeks 25-36	59	72

SecondaryChange of Episodes From Baseline in Mean 72-h Incontinence Episodes

Time frame:: Weeks 1-12, 13-24, 25-36
Reported as:: Least squares mean · episodes

Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
episodes	Electroacupuncture	Solifenacin Plus PFMT
Weeks 1-12	-4.56 (-5.13 to -3.98)	-4.37 (-4.95 to -3.79)
Weeks 13-24	-7.27 (-7.83 to -6.70)	-6.95 (-7.52 to -6.37)
Weeks 25-36	-8.31 (-8.83 to -7.78)	-8.22 (-8.76 to -7.69)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Electroacupuncture	—	0/250 (0%)	41/250 (16.4%)
Solifenacin Plus PFMT	—	1/250 (0.4%)	90/250 (36%)

Most frequent serious events

Most frequent serious events
Event	Electroacupuncture	Solifenacin Plus PFMT
FractureInjury, poisoning and procedural complications	0/250	1/250

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	Electroacupuncture	Solifenacin Plus PFMT
Dry mouthGastrointestinal disorders	0/250	62/250
upper respiratory infectionReproductive system and breast disorders	19/250	10/250
subcutaneous hematomaInjury, poisoning and procedural complications	10/250	0/250
constipationGastrointestinal disorders	0/250	7/250
stomachGastrointestinal disorders	1/250	6/250
dyspepsiaGastrointestinal disorders	0/250	5/250
diarrheaGastrointestinal disorders	3/250	2/250
dizzinessNervous system disorders	2/250	2/250
hypogeusiaNervous system disorders	0/250	2/250
urinary tract infectionNervous system disorders	2/250	0/250

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Acupuncture	Solifenacin Plus PFMT	Total
Mean	54.7 ± 10.11	53.7 ± 9.38	54.2 ± 9.75

Sex: Female, Male
Sex: Female, Male(Participants)	Acupuncture	Solifenacin Plus PFMT	Total
Female	250	250	500
Male	0	0	0

Study locations

1 site

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Beijing, 100053, China

References and documents

Publications

Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2. PubMed 36148895 ↗
Sun B, Liu Y, Su T, Sun Y, Liu Z. Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies. BMJ Support Palliat Care. 2022 May;12(e1):e164-e170. doi: 10.1136/bmjspcare-2019-002034. Epub 2020 Jan 9. PubMed 31919102 ↗
Liu B, Liu Y, Qin Z, Zhou K, Xu H, He L, Li N, Su T, Sun J, Yue Z, Zang Z, Zhang W, Zhao J, Zhou Z, Liu L, Wu D, Wu J, Zhou J, Pang R, Wang Y, Liu J, Yu J, Liu Z. Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial. Mayo Clin Proc. 2019 Jan;94(1):54-65. doi: 10.1016/j.mayocp.2018.07.021. PubMed 30611454 ↗
Liu B, Wang Y, Xu H, Chen Y, Wu J, Mo Q, Liu Z. Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol. BMC Complement Altern Med. 2014 Aug 15;14:301. doi: 10.1186/1472-6882-14-301. PubMed 25128002 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02047032
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Responsible party: Liu Zhishun (Dean of Acupuncture Department of Guangan'men Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences) — Principal investigator
First posted: Jan 28, 2014
Start date: Apr 2014
Primary completion: Aug 2016
Completion: Oct 2016
Results posted: Jun 6, 2019
Last update: Jun 6, 2019

Study contacts

Zhishun Liu, doctor

study director · Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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