Mixed Urinary IncontinenceNCT04299932
Acupuncture for Stress-predominant Mixed Urinary Incontinence
A study testing Electroacupuncture in people with Mixed Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 5 sites in China.
Trial summary
The investigators plan to conduct this multi-center, three-armed, randomized controlled trial to evaluate the efficacy of electroacupuncture (EA), compared with sham electroacupuncture (SA) and waiting list (WL) on participants with stress-predominant mixed urinary incontinence (MUI). Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Mixed Urinary Incontinence
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 5 sitesChina
- Study dates
- 9 Oct 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MUI by the coexistence of SUI and urgency urinary incontinence (UUI) symptoms in accordance with EAU guideline;
- Female participants aged between 35 and 75;
- Stress index > urge index in accordance with Medical, Epidemiologic, and Social aspects of Aging(MESA) questionnaire；
- Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEF documented in 3-day voiding diary;
- Less than 12 micturition episodes in average 24 hours documented in 3-day voiding diary;
- Positive cough stress test;
- Urine leakage > 1 g in 1-hour pad test;
- Voluntary participation in the trial and signed written informed content.
Who cannot join
- Urgency-predominant MUI, pure SUI, pure UUI, overflow urinary incontinence (UI) and neurogenic bladder;
- Uncontrolled symptomatic urinary tack infection;
- Tumor in urinary system and pelvic organ;
- Pelvic organ prolapse ≥ degree Ⅱ；
- Residual urine volume ≥ 100ml；
- History of treatments targeted at UI, such as acupuncture, PFMT and medications in the previous one month;
Show all 14Show fewer
- History of surgery targeted at UI or in pelvic floor, including hysterectomy;
- Uncontrolled diabetes or severe high blood pressure;
- Nervous system diseases that may hamper the function of urinary system, such as Multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina nerve injury, or multiple system atrophy;
- Severe heart, lung, brain, liver, kidney, mental illness, coagulation dysfunction or with obvious cognitive dysfunction
- Installed cardiac pacemaker;
- Inconvenient or unable to walk, run, go up and down stairs;
- Allergy to metal, severely fear of acupuncture needles or unbearable to EA;
- Pregnant at present, plan to conceive in future one year, at lactation period or within 12 months after childbirth.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
Zhishun Liu, zhishunjournal@163.com
- Recruiting
The third affiliated hospital of Beijing university of Chinese Medicine
Beijing, Beijing Municipality
Peng Bai, baipeng1978@163.com
- Recruiting
Hengyang Hospital Affiliated to Hunan University of Chinese Medicine
Hengyang, Hunan
Zenghui Yue, 624755064@qq.com
- Recruiting
Jiangxi Provincial Hospital of traditional Chinese Medicine
Nanchang, Jiangxi
Yong Fu, fuyong1125@163.com
- Recruiting
Yantai Hospital of Traditional Chinese Medicine
Yantai, Shandong
Zhiwei Zang, 860922902@qq.com
About this study
Official title: Electroacupuncture for Stress-predominant Mixed Urinary Incontinence: a Three-armed Randomized Controlled Trial
The investigators plan to conduct this multi-center, three-armed, randomized controlled trial to evaluate the efficacy of electroacupuncture (EA), compared with sham electroacupuncture (SA) and waiting list (WL) on participants with stress-predominant mixed urinary incontinence (MUI).
Read the detailed description
MUI tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. Current European Association of Urology (EAU) guideline on incontinence recommends to initiate treatment targeted at predominant component of MUI. However, as to whether the interventions for stress urinary incontinence (SUI) can be effectively generalized to stress-predominant MUI, there is still no powerful evidence to support it. It is necessary to seek for interventions specific to stress-predominant MUI. Results of previous studies indicated that acupuncture might help to relieve the incontinence symptoms.
- Conditions
- Mixed Urinary Incontinence
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Keywords
- acupuncture, stress-predominant mixed urinary incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Also called EA
BL33 is located in the third posterior sacral foramen; BL35, 0.5 cun (≈10mm) lateral to the extremity of the coccyx; and SP6 posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus. BL33 will be inserted by needles of 0.30×75mm size at the angle of 45°, inward and downward, till the depth of 60-70mm. BL35 will be inserted by needles of 0.30×75mm size, slightly outward and upward, till the depth of 60-70mm. SP6 will be inserted by needles of 0.30×40mm till the depth of 25-30mm. All the needles will be lifted, thrust and twisted evenly for three times, right after insertion, to induce the sensation of deqi. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20 Hertz (Hz), electric current of 2-6.5 milliampere (mA) for BL33 and BL35, and 1mA-3.5mA for SP6.
Sham electroacupunctureProcedure or surgery
Also called SA
Sham BL33 is in the area of 1 cun (≈20mm) horizontally outside BL33; sham BL35, 1 cun (≈20mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The three pairs of acupoints will be inserted by needles of 0.30×40mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20Hz and minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture(EA) group | Experimental | Participants in EA group will receive treatment at bilateral Bladder Meridian (BL) 33 [Zhongliao], BL35 [Huiyang] and Spleen Meridian (SP) 6 [Sanyinjiao]. The EA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks. Receives: Procedure: Electroacupuncture |
| Sham Electroacupuncture (SA) group | Sham comparator | Participants in SA group will receive treatment at bilateral sham BL33 [Zhongliao], sham BL35 [Huiyang] and sham SP6 [Sanyinjiao]. The SA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks. Receives: Procedure: Sham electroacupuncture |
| Waiting List (WL) group | No intervention | Participants in WL group will be followed up for 20 weeks. Participants only receive healthcare education and advice on lifestyle modification, which will be received by all the participants in the three groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline.
The stress IEF will be documented in 3-day voiding diary.
Measured: week 8
Secondary outcomes (12)
Proportion of participants with at least 50% reduction of urinary leakage amount from baseline.
The urinary leakage amount will be measured by 1 hour pad test.
Measured: week 8
Change of urinary leakage amount from baseline
The urinary leakage amount will be measured by 1 hour pad test.
Measured: week 8
Proportion of participants with at least 50% reduction of mean 24-hour stress IEF from baseline.
The stress IEF will be documented in 3-day voiding diary.
Measured: week 4，week 20 and week 32
Change of mean 24-hour IEF from baseline.
The IEF will be documented in 3-day voiding diary.
Measured: week 4，week 8, week 20 and week 32.
Change of mean 24-hour stress IEF from baseline
The stress IEF is documented in 3-day voiding diary.
Measured: week 4，week 8, week 20 and week 32.
Proportion of participants with at least 50% reduction of mean 24-hour IEF from baseline
The IEF will be documented in 3-day voiding diary.
Measured: week 4，week 8, week 20 and week 32
Change of total and sub-score of International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) from baseline.
ICIQ-SF questionnaire is a validated questionnaire to assess the severity of incontinence symptoms and influence on QoL in the past four weeks. The questionnaire includes items of IEF, urinary leakage amount and general influence on life to be scored. Total number of the score ranges from 1 to 21, with higher scores representing greater severity and 2.52 as minimal clinically important differences.
Measured: week 4，week 8, week 20 and week 32
Change of total and sub-score of Overactive Bladder Questionnaire short form (OAB-q SF) from baseline
OAB-q SF is a validated questionnaire used to assess the OAB symptom bother and the health-related quality of life (HRQL) in the past 4 weeks. The domains include coping, concern, sleep and emotional interactions. The scores are transformed to a 0- to 100-point scale, with higher scores indicating severe symptoms and better HRQL.
Measured: week 4，week 8, week 20 and week 32
Change of mean 24-hour pad consumption from baseline
The pad consumption will be documented in 3-day voiding diary.
Measured: week 4，week 8, week 20 and week 32
Proportion of participants with adequate improvement assessed by Patient global impression improvement (PGI-I).
PGI-I is a global index, with only one item, used to rate the participants' subject perception on symptom improvement. Participants will describe their impression from very much better to very much worse. Adequate Improvement is defined as the response of"much better" or "very much better".
Measured: week8, week 20
Change of mean 24-hour urgency episodes from baseline
The urgency episodes will be documented in 3-day voiding diary.
Measured: week 4，week 8, week 20 and week 32
Change of mean 24-hour micturition episodes from baseline
The micturition episodes will be documented in 3-day voiding diary.
Measured: week 4，week 8, week 20 and week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start9 Oct 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mixed Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Study chair, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299932
- Sponsor's protocol ID
- 2019-241-KY
- Status last verified
- Jan 2021
- First submitted
- 5 Mar 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in the article after deidentification, excluding the private information of participants.
Publications
Sun Y, Liu Y, Chen H, Yan Y, Liu Z. Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial. BMJ Open. 2021 Jan 7;11(1):e038452. doi: 10.1136/bmjopen-2020-038452.
PubMed 33414139
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Stress-predominant Mixed Urinary Incontinence: a Three-armed Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04299932
- Acronym / sponsor ID
- 2019-241-KY
- Conditions
- Mixed Urinary Incontinence
- Keywords
- acupuncture, stress-predominant mixed urinary incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to conduct this multi-center, three-armed, randomized controlled trial to evaluate the efficacy of electroacupuncture (EA), compared with sham electroacupuncture (SA) and waiting list (WL) on participants with stress-predominant mixed urinary incontinence (MUI).
Detailed description
MUI tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. Current European Association of Urology (EAU) guideline on incontinence recommends to initiate treatment targeted at predominant component of MUI. However, as to whether the interventions for stress urinary incontinence (SUI) can be effectively generalized to stress-predominant MUI, there is still no powerful evidence to support it. It is necessary to seek for interventions specific to stress-predominant MUI. Results of previous studies indicated that acupuncture might help to relieve the incontinence symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture(EA) group | Experimental | Procedure: ElectroacupunctureParticipants in EA group will receive treatment at bilateral Bladder Meridian (BL) 33 [Zhongliao], BL35 [Huiyang] and Spleen Meridian (SP) 6 [Sanyinjiao]. The EA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks. |
| Sham Electroacupuncture (SA) group | Sham comparator | Procedure: Sham electroacupunctureParticipants in SA group will receive treatment at bilateral sham BL33 [Zhongliao], sham BL35 [Huiyang] and sham SP6 [Sanyinjiao]. The SA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks. |
| Waiting List (WL) group | No intervention | –Participants in WL group will be followed up for 20 weeks. Participants only receive healthcare education and advice on lifestyle modification, which will be received by all the participants in the three groups. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of MUI by the coexistence of SUI and urgency urinary incontinence (UUI) symptoms in accordance with EAU guideline;
- Female participants aged between 35 and 75;
- Stress index > urge index in accordance with Medical, Epidemiologic, and Social aspects of Aging(MESA) questionnaire；
- Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEF documented in 3-day voiding diary;
- Less than 12 micturition episodes in average 24 hours documented in 3-day voiding diary;
Key exclusion criteria (14 listed)
- Urgency-predominant MUI, pure SUI, pure UUI, overflow urinary incontinence (UI) and neurogenic bladder;
- Uncontrolled symptomatic urinary tack infection;
- Tumor in urinary system and pelvic organ;
- Pelvic organ prolapse ≥ degree Ⅱ；
- Residual urine volume ≥ 100ml；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureAlso: EABL33 is located in the third posterior sacral foramen; BL35, 0.5 cun (≈10mm) lateral to the extremity of the coccyx; and SP6 posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus. BL33 will be inserted by needles of 0.30×75mm size at the angle of 45°, inward and downward, till the depth of 60-70mm. BL35 will be inserted by needles of 0.30×75mm size, slightly outward and upward, till the depth of 60-70mm. SP6 will be inserted by needles of 0.30×40mm till the depth of 25-30mm. All the needles will be lifted, thrust and twisted evenly for three times, right after insertion, to induce the sensation of deqi. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20 Hertz (Hz), electric current of 2-6.5 milliampere (mA) for BL33 and BL35, and 1mA-3.5mA for SP6. | Procedure or surgery | Electroacupuncture(EA) group |
| Sham electroacupunctureAlso: SASham BL33 is in the area of 1 cun (≈20mm) horizontally outside BL33; sham BL35, 1 cun (≈20mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The three pairs of acupoints will be inserted by needles of 0.30×40mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20Hz and minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on. | Procedure or surgery | Sham Electroacupuncture (SA) group |
Primary outcome
Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline.
Time frame: week 8
The stress IEF will be documented in 3-day voiding diary.
12 secondary outcomes
Proportion of participants with at least 50% reduction of urinary leakage amount from baseline.
Time frame: week 8
Change of urinary leakage amount from baseline
Time frame: week 8
Proportion of participants with at least 50% reduction of mean 24-hour stress IEF from baseline.
Time frame: week 4，week 20 and week 32
Change of mean 24-hour IEF from baseline.
Time frame: week 4，week 8, week 20 and week 32.
Change of mean 24-hour stress IEF from baseline
Time frame: week 4，week 8, week 20 and week 32.
Proportion of participants with at least 50% reduction of mean 24-hour IEF from baseline
Time frame: week 4，week 8, week 20 and week 32
Change of total and sub-score of International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) from baseline.
Time frame: week 4，week 8, week 20 and week 32
Change of total and sub-score of Overactive Bladder Questionnaire short form (OAB-q SF) from baseline
Time frame: week 4，week 8, week 20 and week 32
Change of mean 24-hour pad consumption from baseline
Time frame: week 4，week 8, week 20 and week 32
Proportion of participants with adequate improvement assessed by Patient global impression improvement (PGI-I).
Time frame: week8, week 20
Change of mean 24-hour urgency episodes from baseline
Time frame: week 4，week 8, week 20 and week 32
Change of mean 24-hour micturition episodes from baseline
Time frame: week 4，week 8, week 20 and week 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Derived from this study: PubMed 33414139Sun Y, Liu Y, Chen H, Yan Y, Liu Z. Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial. BMJ Open. 2021 Jan 7;11(1):e038452. doi: 10.1136/bmjopen-2020-038452.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in the article after deidentification, excluding the private information of participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu study chair
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Mixed Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhishun Liu (+861088002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline. (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.