Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence (EASE-UMUI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03787654
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Tracking Information
First Submitted Date  ICMJE December 22, 2018
First Posted Date  ICMJE December 25, 2018
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2018)
Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 12 ]
3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03787654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Proportion of subjects with at least 50% reduce of urgency urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Proportion of subjects with complete resolution of urgency urinary incontinence episodes in average 24 hours based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Proportion of subjects with at least 50% reduce of urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of voiding episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of voiding episodes graded as 3/4 in average 24 hours from baseline based on the Patient Perception of Intensity of Urgency Scale( PPIUS). [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    Patient Perception of Intensity of Urgency Scale (PPIUS) is recommended by the European Medicines Agency to grade the urgency of voiding. Voiding graded at 1 and 2 levels of urgency are regarded as normal or strong desire to void rather than urgency, while 3 and 4 levels are regarded as urgency episodes.
  • Change of nocturia episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of pad consuming in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • volume change of water intake in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF ) score from baseline. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    ICIQ-UI-SF was a questionnaire developed by the International Consultation on Incontinence to evaluate the severity of incontinence and impact to QoL in the past four weeks. It contains four items: frequency, amount of leakage, impact of UI on QoL and a separate item to indicate the cause of incontinence. The score was the sum of the first three items, providing a total score ranging from 0 to 21 with a higher score indicating worse symptoms and greater impact on QoL.
  • Change of Overactive bladder questionnaire short form (OABq-SF) score from baseline. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    OABq-SF is a validated questionnaire to assess the bother of OAB symptoms and effect on QoL in the past four weeks. It includes coping, sleep and emotional interaction. The scores were transformed to a 0- to 100-point scale, and higher scores on the symptom-severity scale indicate worse symptoms, whereas higher scores on the QoL scale indicate better quality of life.
  • Proportion of subjects with adequate improvement assessed by Patient global impression improvement (PGI-I). [ Time Frame: week 12, week 36 ]
    Patient global impression improvement (PGI-I) is a scale range from 1 to 7, with 1 indicating very much better and 7 indicating very much worse. Adequate improvement is defined as a rating of 1 or 2 by PGI-I.
  • Change of residual urinary volume from baseline tested by abdominal B-ultrasound. [ Time Frame: week 12 ]
    Abdominal B-ultrasound is objective way to test the residual urinary volume.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2018)
  • Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Proportion of subjects with at least 50% reduce of urgency urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Proportion of subjects with complete resolution of urgency urinary incontinence episodes in average 24 hours based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Proportion of subjects with at least 50% reduce of urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of voiding episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of voiding episodes graded as 3/4 in average 24 hours from baseline based on the Patient Perception of Intensity of Urgency Scale( PPIUS). [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    Patient Perception of Intensity of Urgency Scale (PPIUS) is recommended by the European Medicines Agency to grade the urgency of voiding. Voiding graded at 1 and 2 levels of urgency are regarded as normal or strong desire to void rather than urgency, while 3 and 4 levels are regarded as urgency episodes.
  • Change of nocturia episodes in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of pad consuming in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • volume change of water intake in average 24 hours from baseline based on 3-day voiding diary. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.
  • Change of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF ) score from baseline. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    ICIQ-UI-SF was a questionnaire developed by the International Consultation on Incontinence to evaluate the severity of incontinence and impact to QoL in the past four weeks. It contains four items: frequency, amount of leakage, impact of UI on QoL and a separate item to indicate the cause of incontinence. The score was the sum of the first three items, providing a total score ranging from 0 to 21 with a higher score indicating worse symptoms and greater impact on QoL.
  • Change of Overactive bladder questionnaire short form (OABq-SF) score from baseline. [ Time Frame: week 4, week 8, week 12, week 24, week 36 ]
    OABq-SF is a validated questionnaire to assess the bother of OAB symptoms and effect on QoL in the past four weeks. It includes coping, sleep and emotional interaction. The scores were transformed to a 0- to 100-point scale, and higher scores on the symptom-severity scale indicate worse symptoms, whereas higher scores on the QoL scale indicate better quality of life.
  • Proportion of subjects with different degrees of satisfaction assessed by Patient global impression improvement (PGI-I). [ Time Frame: week 12, week 36 ]
    Patient global impression improvement (PGI-I) is a scale range from 1 to 7, with 1 indicating very much better and 7 indicating very much worse.
  • Proportion of subjects with at least moderate degree of satisfaction assessed by Patient global impression improvement (PGI-I). [ Time Frame: week 12, week 36 ]
    Patient global impression improvement (PGI-I) is a scale range from 1 to 7, with 1 indicating very much better and 7 indicating very much worse.
  • Change of residual urinary volume from baseline tested by abdominal B-ultrasound. [ Time Frame: week 12 ]
    Abdominal B-ultrasound is objective way to test the residual urinary volume.
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2019)
  • Proportion of subjects bearing expectancy towards acupuncture [ Time Frame: baseline ]
    Expectancy of acupuncture will be recorded at baseline. Participants will be asked to answer two questions: "In general, do you believe acupuncture is effective in treating diseases?" and "Do you think acupuncture is effective in improving the symptoms of incontinence?" Subjects will choose answer from "Have no idea", "Yes" or "No".
  • Proportion of subjects successfully blinded [ Time Frame: week 12 ]
    Within 5 minutes after any treatment in week 12, subjects will be asked the question that: "Do you think you have received traditional electroacupuncture in the past 12 weeks?" Answer will be chosen from "Yes" or "No". The answer of "yes" indicates successful blinding.
  • Incidence of adverse events [ Time Frame: week 0-36 ]
    Side effects induced by Solifenacin mainly include dry mouth, dry eye and constipation. Unintended events and feelings related to EA and SEA include broken needles, fainting, bleeding, bruising, infection and aposteme, unbearable ache (VAS≥8), vomiting, nausea, palpitations, dizziness, headache, anorexia and insomnia, etc. Adverse events irrelevant with the treatment will also be recorded in detail.
Original Other Pre-specified Outcome Measures
 (submitted: December 24, 2018)
  • Proportion of subjects bearing expectancy towards acupuncture [ Time Frame: baseline ]
    Expectancy of acupuncture will be recorded at baseline. Participants will be asked to answer two questions: "In general, do you believe acupuncture is effective in treating diseases?" and "Do you think acupuncture is effective in improving the symptoms of incontinence?" Subjects will choose answer from "Have no idea", "Yes" or "No".
  • Proportion of subjects successfully blinded [ Time Frame: week 12 ]
    Within 5 minutes after any treatment in week 12, subjects will be asked the question that: "Do you think you have received traditional electroacupuncture in the past 12 weeks?" Answer will be chosen from "Have no idea", "Yes" or "No". The answer of "have no idea" indicates successful blinding.
  • Incidence of adverse events [ Time Frame: week 0-36 ]
    Side effects induced by Solifenacin mainly include dry mouth, dry eye and constipation. Unintended events and feelings related to EA and SEA include broken needles, fainting, bleeding, bruising, infection and aposteme, unbearable ache (VAS≥8), vomiting, nausea, palpitations, dizziness, headache, anorexia and insomnia, etc. Adverse events irrelevant with the treatment will also be recorded in detail.
 
Descriptive Information
Brief Title  ICMJE Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence
Official Title  ICMJE Effect of Electroacupuncture for Women With Urgency-predominant Mixed Urinary Incontinence: a Three Armed Non-inferior Randomized Controlled Trial
Brief Summary

The study is to determine the effect of electroacupuncture in female patients with urgency-predominant mixed urinary incontinence. A three-arm non-inferior randomized controlled trial (RCT) using electroacupuncture, sham electroacupuncture and solifenacin with a total sample of 282 is proposed.

The hypothesis is that the improvement (difference in number of urgency urinary incontinence episodes between baseline and 12-week evaluation) in the electroacupuncture group would be 50% or less of the difference in the improvement between the Solifenacin and the sham electroacupuncture groups.

Detailed Description

Mixed urinary incontinence (MUI) features complaint or involuntary loss of urine associated with urgency and also with effort or physical exertion or on sneezing or coughing. It is regarded as urgency-predominant mixed urinary incontinence (UMUI) when sudden sensation of voiding accompanied by uncontrolled incontinence domains the symptoms. UMUI can bring shame and inconvenience to patients.

As first-line medicine for urge-predominant urinary incontinence, Solifenacin can reduce urgency urinary incontinence episodes in 24 hours. However, the side effects tend to bring about poor compliance among patients.

Acupuncture might be effective in treating UMUI. Previous research indicated that electroacupuncture might be noninferior to pelvic floor muscle training plus Solifenacin in reducing the urgency incontinence episodes of UMUI women. However, that study didn't focuse on UMUI exclusively, thus unable to decide whether electroacupuncture is effective in the treatment of UMUI.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
participants in electroacupuncture and sham electroacupuncture groups are blinded, and solifenacin group is open.
Primary Purpose: Treatment
Condition  ICMJE
  • Mixed Urinary Incontinence
  • Urgency-predominant Mixed Urinary Incontinence
Intervention  ICMJE
  • Device: electroacupuncture

    BL33 and BL35 are inserted by needles of 0.30×75mm size till a depth of 60~70mm. SP6 is inserted by needle of 0.30×40mm size till a depth of 25-30mm. After manipulation and deqi sensation generation, the electrodes will be attached to the acupoints transversely with 20Hz continuous wave and an electricity current of 2mA-6.5mA at BL33 and BL35, and 1-3.5mA at SP6. The current is adjusted from zero to the degree where patients can tolerate.

    Subjects receive 3 sessions per week(every other day ideally) for 12 weeks, 36 sessions in total.

    Other Name: EA group
  • Device: sham electroacupuncture

    In sham electroacupuncture group, sham acupoints 1 cun(≈15mm) horizontally outwardly lateral to BL33 and BL35, and 0.5 cun (≈10mm) horizontally behind SP6 are stimulated by needles of 0.30×40mm size. The needles are inserted to a depth of 2-3mm to stand still, without any manipulation and sensation of deqi. The electrodes will also be attached to needles with an electricity current of 0.1-0.3mA.

    The sessions will be the same as the electroacupuncture group.

    Other Name: SEA group
  • Drug: Solifenacin
    Subjects take solifenacin 5-10mg per day for a succession of 36 weeks. The dose change is decided by doctors under a comprehensive consideration of side effects and Patient Global Symptom Control (PGSC), which is applied to evaluate the effectiveness of Solifenacin at the 4th, 8th, 12th and 24th week.The medicine can be discontinued at any time if the adverse effect is rather severe.
    Other Name: Drug group
Study Arms  ICMJE
  • Experimental: electroacupuncture group
    Acupoints of bilateral Zhongliao (BL33), Huiyang (BL35) and Sanyinjiao (SP6) are stimulated by Huatuo Brand disposable needles and SDZ-V electronic apparatus.
    Intervention: Device: electroacupuncture
  • Sham Comparator: sham electroacupuncture group
    Sham acupoints 1 cun(≈15mm) horizontally outwardly lateral to BL33 and BL35, and 0.5 cun(≈10mm) horizontally behind SP6 are stimulated superficially with a small electricity current by needles of 0.30×40mm size and SDZ-V electronic apparatus.
    Intervention: Device: sham electroacupuncture
  • Active Comparator: Solifenacin group
    subjects will orally take Solifenacin 5-10mg per day.
    Intervention: Drug: Solifenacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 24, 2018)
282
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female patients diagnosed with mixed urinary incontinence in accordance with EAU guideline by history intaking and physical examination[8];
  2. Age between 18 and 80 years old;
  3. Urgency index greater than stress index by MESA questionnaire[12];
  4. At least 4 episodes of urgency urinary incontinence in 72-hour voiding diary;
  5. More than 50% of the total incontinence episodes is urgency one in 72-hour voiding diary;
  6. Positive cough test;
  7. A voluntarily-signed written informed content.

Exclusion Criteria:

  1. Having pure stress urinary incontinence, pure urgency urinary incontinence, overflow urinary incontinence or neurogenic bladder;
  2. Uncontrolled urinary tract infection;
  3. Tumor in urinary system or pelvic organs;
  4. Pelvic organ prolapse≥degreeⅡ;
  5. Residual urine volume≥100ml;
  6. Maximum flow rate<15ml/s;
  7. Treated incontinence by acupuncture or positive medications, such as antimuscarinic drug within the past 1 month;
  8. Underwent surgery of anti-incontinence or in pelvic area, metrectomy included;
  9. Complication of uncontrolled diabetes and severe hypertension;
  10. Complicated diseases in nerves system that could hamper hypourethral function, such as Multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, cauda equina nerve injury and multiple system atrophy;
  11. Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability;
  12. Installed a cardiac pacemaker;
  13. Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis, angle-closure glaucoma;
  14. Allergic to metal or intolerant to the stimulation of electroacupuncture;
  15. Already with child or plan to conceive in the future 1 year, or within 1 year after delivery.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhishun Liu, PhD 86-10-88002331 zhishunjournal@163.com
Contact: Yuanjie Sun, Master 86-010-18810337542 puzhisun@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03787654
Other Study ID Numbers  ICMJE 2018-163-KY
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yan Liu, Master Dong Zhi Men Hospital
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP