Mixed Urinary IncontinenceEASE-UMUINCT03787654
Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence
A study testing electroacupuncture and Solifenacin in people with Mixed Urinary Incontinence and Urgency-predominant Mixed Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Mixed Urinary Incontinence, Urgency-predominant Mixed Urinary Incontinence
- What is being tested?
- electroacupuncture and Solifenacin
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 30 Jun 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients diagnosed with mixed urinary incontinence in accordance with EAU guideline by history intaking and physical examination[8];
- Age between 18 and 80 years old;
- Urgency index greater than stress index by MESA questionnaire[12];
- At least 4 episodes of urgency urinary incontinence in 72-hour voiding diary;
- With MUI for at least 3 months, and more than 50% of the total incontinence episodes is urgency one in 72-hour voiding diary;
- Positive cough test;
- A voluntarily-signed written informed content.
Who cannot join
- Having pure stress urinary incontinence, pure urgency urinary incontinence, overflow urinary incontinence or neurogenic bladder;
- Uncontrolled urinary tract infection;
- Tumor in urinary system or pelvic organs;
- Pelvic organ prolapse≥degreeⅡ;
- Residual urine volume≥100ml;
- Maximum flow rate<15ml/s;
Show all 15Show fewer
- Treated incontinence by acupuncture or positive medications, such as antimuscarinic drug within the past 1 month;
- Underwent surgery of anti-incontinence or in pelvic area, metrectomy included;
- Complication of uncontrolled diabetes and severe hypertension;
- 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;
- Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability;
- Installed a cardiac pacemaker;
- Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis, angle-closure glaucoma;
- Allergic to metal or intolerant to the stimulation of electroacupuncture;
- Already with child or plan to conceive in the future 1 year, or within 1 year after delivery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang An Men Hospital
Beijing, 100053
Yuanjie Sun, Master, 861088002331, puzhisun@163.com
About this study
Official title: Effect of Electroacupuncture for Women With Urgency-predominant Mixed Urinary Incontinence: a Three Armed Non-inferior Randomized Controlled Trial
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.
Read the 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.
- Being tested
- electroacupuncture, sham electroacupuncture, Solifenacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
Also called EA group
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.
sham electroacupunctureDevice
Also called SEA group
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.
SolifenacinDrug
Also called Drug group
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.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture group | Experimental | Acupoints of bilateral Zhongliao (BL33), Huiyang (BL35) and Sanyinjiao (SP6) are stimulated by Huatuo Brand disposable needles and SDZ-V electronic apparatus. Receives: Device: electroacupuncture |
| sham electroacupuncture group | Sham comparator | 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. Receives: Device: sham electroacupuncture |
| Solifenacin group | Active comparator | subjects will orally take Solifenacin 5-10mg per day. Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.
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.
Measured: week 12
Secondary outcomes (14)
Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.
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.
Measured: week 4, week 8, week 24, week 36
Change of urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.
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.
Measured: week 4, week 8, week 12, week 24, week 36
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.
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.
Measured: week 4, week 8, week 12, week 24, week 36
Proportion of subjects with complete resolution of urgency urinary incontinence episodes in average 24 hours based on 3-day voiding diary.
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.
Measured: week 4, week 8, week 12, week 24, week 36
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.
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.
Measured: week 4, week 8, week 12, week 24, week 36
Change of voiding episodes in average 24 hours from baseline based on 3-day voiding diary.
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.
Measured: week 4, week 8, week 12, week 24, week 36
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).
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.
Measured: week 4, week 8, week 12, week 24, week 36
Change of nocturia episodes in average 24 hours from baseline based on 3-day voiding diary.
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.
Measured: week 4, week 8, week 12, week 24, week 36
Change of pad consuming in average 24 hours from baseline based on 3-day voiding diary.
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.
Measured: week 4, week 8, week 12, week 24, week 36
volume change of water intake in average 24 hours from baseline based on 3-day voiding diary.
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.
Measured: week 4, week 8, week 12, week 24, week 36
Change of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF ) score from baseline.
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.
Measured: week 4, week 8, week 12, week 24, week 36
Change of Overactive bladder questionnaire short form (OABq-SF) score from baseline.
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.
Measured: week 4, week 8, week 12, week 24, week 36
Proportion of subjects with adequate improvement assessed by Patient global impression improvement (PGI-I).
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.
Measured: week 12, week 36
Change of residual urinary volume from baseline tested by abdominal B-ultrasound.
Abdominal B-ultrasound is objective way to test the residual urinary volume.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Mar 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, PhD, Principal investigator, Guanganmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787654
- Sponsor's protocol ID
- 2018-163-KY
- Acronym
- EASE-UMUI
- Status last verified
- Feb 2022
- First submitted
- 22 Dec 2018
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun Y, Liu Y, Su T, Sun J, Wu Y, Liu Z. Electroacupuncture versus solifenacin for women with urgency-predominant mixed urinary incontinence: a protocol for a three-armed non-inferiority randomized controlled trial. BMC Complement Med Ther. 2020 Jan 23;20(1):18. doi: 10.1186/s12906-019-2784-1.
PubMed 32020889
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture for Women With Urgency-predominant Mixed Urinary Incontinence: a Three Armed Non-inferior Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03787654
- Acronym / sponsor ID
- EASE-UMUI / 2018-163-KY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Dec 2018 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture group | Experimental | Device: electroacupunctureAcupoints of bilateral Zhongliao (BL33), Huiyang (BL35) and Sanyinjiao (SP6) are stimulated by Huatuo Brand disposable needles and SDZ-V electronic apparatus. |
| sham electroacupuncture group | Sham comparator | Device: sham electroacupunctureSham 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. |
| Solifenacin group | Active comparator | Drug: Solifenacinsubjects will orally take Solifenacin 5-10mg per day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients diagnosed with mixed urinary incontinence in accordance with EAU guideline by history intaking and physical examination[8];
- Age between 18 and 80 years old;
- Urgency index greater than stress index by MESA questionnaire[12];
- At least 4 episodes of urgency urinary incontinence in 72-hour voiding diary;
- With MUI for at least 3 months, and more than 50% of the total incontinence episodes is urgency one in 72-hour voiding diary;
Key exclusion criteria (15 listed)
- Having pure stress urinary incontinence, pure urgency urinary incontinence, overflow urinary incontinence or neurogenic bladder;
- Uncontrolled urinary tract infection;
- Tumor in urinary system or pelvic organs;
- Pelvic organ prolapse≥degreeⅡ;
- 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: EA groupBL33 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. | Device | electroacupuncture group |
| sham electroacupunctureAlso: SEA groupIn 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. | Device | sham electroacupuncture group |
| SolifenacinAlso: Drug groupSubjects 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. | Drug | Solifenacin group |
Primary outcome
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.
14 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Change of Overactive bladder questionnaire short form (OABq-SF) score from baseline.
Time frame: week 4, week 8, week 12, week 24, week 36
Proportion of subjects with adequate improvement assessed by Patient global impression improvement (PGI-I).
Time frame: week 12, week 36
Change of residual urinary volume from baseline tested by abdominal B-ultrasound.
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Derived from this study: PubMed 32020889Sun Y, Liu Y, Su T, Sun J, Wu Y, Liu Z. Electroacupuncture versus solifenacin for women with urgency-predominant mixed urinary incontinence: a protocol for a three-armed non-inferiority randomized controlled trial. BMC Complement Med Ther. 2020 Jan 23;20(1):18. doi: 10.1186/s12906-019-2784-1.
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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, PhD principal investigator
Guanganmen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture and Solifenacin in people with Mixed Urinary Incontinence and Urgency-predominant Mixed Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site 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 7 inclusion and 15 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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, PhD (86-10-88002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary. (time frame: week 12). 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 NCT03787654, 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 4 Feb 2022.