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Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
solifenacin
PFMT
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring electroacupuncture, urinary incontinence, PFMT, Solifenacin

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

acupuncture

Solifenacin plus PFMT

Arm 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).

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.
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.
Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 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).
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.
Patient Global Impression Improvement
Participants will be asked to finish one item evaluating their present condition.
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.
The Number of Participants Using Urine Pads
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes

Full Information

First Posted
January 23, 2014
Last Updated
March 3, 2019
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02047032
Brief Title
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
electroacupuncture, urinary incontinence, PFMT, Solifenacin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm 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).
Arm Title
Solifenacin plus PFMT
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
electroacupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
competitive cholinergic receptor antagonist
Intervention Description
Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
Intervention Type
Procedure
Intervention Name(s)
PFMT
Other Intervention Name(s)
pelvic floor muscle training
Intervention Description
Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
Title
Patient Global Impression Improvement
Description
Participants will be asked to finish one item evaluating their present condition.
Time Frame
Weeks 12, 36
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
Title
The Number of Participants Using Urine Pads
Time Frame
Weeks 1-12, 13-24, 25-36
Title
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Time Frame
Weeks 1-12, 13-24, 25-36

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, doctor
Organizational Affiliation
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
City
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36148895
Citation
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.
Results Reference
derived
PubMed Identifier
31919102
Citation
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.
Results Reference
derived
PubMed Identifier
30611454
Citation
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.
Results Reference
derived
PubMed Identifier
25128002
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence

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