An interventional study of Sacral acupoints acupuncture and Abdominal acupoints acupuncture in Stress Urinary Incontinence, sponsored by Yin Ping. Recruiting at 1 site in China. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Yin Ping · Not applicable, Interventional, and Treatment
Among 22 studies in Urinary Incontinence, Stress with a site in China — 6 open to participants now, 6 under way, 1 of them phase 3. Urinary Incontinence, Stress · China.
Among the 22 studies in Urinary Incontinence, Stress with a site in China, this one is the 5th largest by planned enrollment of the 20 interventional ones that give a count, is one of 3 that started in 2023, is one of 15 with no phase, and was the 12th registered.
653 studies on the registry are indexed under Urinary Incontinence, Stress; 121 are open to participants now.
Browse Urinary Incontinence, Stress studies →6 of the 22 studies in Urinary Incontinence, Stress with a site in China are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in China, United States, Canada and 6 more countries
Ages 18+ · Women only
Jie Li · Sites in China
Ages 18+ · Women only
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 20–90 · Women only
Peking University People's Hospital · Sites in China
Ages 20–40 · Women only · Healthy volunteers
Peking Union Medical College Hospital · Sites in China
Ages 18–60 · Women only · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 74 Urinary Incontinence, Stress studies recruiting now, 42 (57%) set no upper age limit and 18 (24%) stop at 75 or younger; 2 take children under 18; 16 take healthy volunteers.
This study: 40 Years to 75 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 360 is above the median of 68 across 508 interventional studies indexed under Urinary Incontinence, Stress.
Median enrollment 137 across the 20 interventional studies, 1,191 across the 2 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 22 have an industry lead sponsor. The 10 most frequent:
Yin Ping is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Yin Ping has 1 study filed under Urinary Incontinence, Stress — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Urinary Incontinence, Stress with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This multicenter randomized controlled trial is designed to explore a relatively suitable application of acupoint combinations and to provide certain clinical evidence for the optimization of acupuncture treatment of female SUI.
Stress urinary incontinence (SUI) mainly refers to the involuntary leakage of urine when abdominal pressure increases, such as sneezing, coughing, laughing or exercise. According to epidemiological studies, the global median prevalence of female urinary incontinence is 27.6% (4.8%-58.4%), of which SUI accounts for more than 50%. Previous study have demonstrated that acupuncture intervention can reduce the urine leakage in pad test, decrease the ICIQ-SF score, so as to help the patients alleviate the symptoms and improve their quality of life. This multicenter randomized controlled trial set 3 groups. Patients will receive 3 different applications of acupoint combinations so that the optimization of acupuncture treatment of female SUI will be find.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive sacral acupoints combination treatment at bilaterally Huiyang(BL35) and Zhongliao(BL33) with prone position during the whole treatment course.
Device: Sacral acupoints acupuncture
Participants will receive abdominal acupoints combination treatment at unilateral Zhongji(RN3), Guanyuan(RN4) and bilaterally Dahe(KI12) with dorsal position during the whole treatment course.
Device: Abdominal acupoints acupuncture
Participants will receive treatment of sacral acupoints combination and abdominal acupoints combination alternately. (For example, A for the first time, B for the second time, A for the third time, and so on. )
Device: Alternating acupoints acupuncture
Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. In this group, paired electrodes from the electroacupuncture apparatus were attached transversely to the needle handles at bilateral Huiyang(BL35) and Zhongliao(BL33) .
Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. In this group, paired electrodes from the electroacupuncture apparatus were attached to the needle handles respectively at Zhongji(RN3) and one side of Dahe(KI12), as well as Guanyuan(RN4) and another side of Dahe(KI12).
Before treatment, the participants will be asked to go to the toilet. All treatments will be performed after skin disinfection. As acupuncture needles are inserted, all points will be lifted, twisted, and stabbed to activate the sensation of de qi. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 50 Hz and a current intensity of 1 to 5 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive three treatments per week (every other day), each lasting 30 minutes, for a total of 18 sessions over the course of 6 weeks. The follow-up sessions are on week 18, 30, 42 and 54. The application of electroacupuncture is the same as Sacral group and Abdominal group.
The change of urine leakage measured by the 1-hour pad test
Quantity of fluid loss will be measured by 1-hour pad test, compared with the baseline (week 0).
Time frame: Week 6
The change of mean episodes of urinary incontinence in 72 hours
The mean episodes of urinary incontinence in 72 hours based on '72 hours bladder diary', comparing the value at week 4, 6, 18, 30, 42 and 54 with the baseline(week 0).
Time frame: Week 4, 6, 18, 30, 42 and 54
The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
ICIQ-SF is a brief instrument used to assess the frequency of incontinence, the volume of incontinence, as well as the impact of life quality). The value will be recorded at week 4, 6, 18, 30, 42 and 54, compared to that at baseline(week 0).
Time frame: Week 4, 6, 18, 30, 42 and 54
Severity of SUI according to '72 hours bladder diary'
The severity of SUI will be rated according to the amount of UI in usual conditions without extreme activities like severe cough, strenuous exercise or carrying heavy loads in the past 72 hours. Definition: mild(several drops of leakage);moderate(leak that soaked through underwear); severe(leak that soaked through outerwear). In case that participants worn urinal pads, the severity of SUI will be graded as follows. Mild(several drops of leakage); moderate(soaked urine pads in patches by several leakages); severe(soaked urine pads in patches by one leakage). The most severe degree of urine leakage in patient's 72 hours bladder diaries over the assessment period will be selected as the severity of SUI for analyses.
Time frame: Week 4, 6, 18, 30, 42 and 54
Participant Self-evaluation of Therapeutic Effects
No help=0; Small help=1; Medium help=2; Great help=3
Time frame: Week 4, 6, 18, 30, 42 and 54
The number of patients who used other treatment for SUI
Compare the number of patients who used other specialty therapy for SUI during the study between 3 groups.
Time frame: Week 18, 30, 42 and 54
Bladder neck mobility by pelvic floor ultrasonography
Bladder neck mobility will be observed both at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be measured from the ultrasonic image.
Time frame: Week 6
Urethral rotation angle by pelvic floor ultrasonography
Urethral rotation angle will be observed both at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be measured from the ultrasonic image.
Time frame: Week 6
Retrovesical angle by pelvic floor ultrasonography
Retrovesical angle will be observed both at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be measured from the ultrasonic image.
Time frame: Week 6
Lowest point of bladder by pelvic floor ultrasonography
Lowest point of bladder at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.
Time frame: Week 6
Urethral funnel formation by pelvic floor ultrasonography
Urethral funnel formation at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.
Time frame: Week 6
The type of bladder bulging by pelvic floor ultrasonography
The type of bladder bulging at rest and during a Valsalva maneuver by pelvic floor ultrasonography. The result can be observed from the ultrasonic image.
Time frame: Week 6
Subgroup analysis: correlation between 1-hour pad test and severity of SUI
Analyze the correlation between 1-hour pad test and severity of SUI.
Time frame: Week 6
Subgroup analysis: correlation between episodes of urinary incontinence in 72 hours and severity of SUI
Analyze the correlation between episodes of urinary incontinence in 72 hours and severity of SUI.
Time frame: Week18, 30, 42 and 54
Number of urine pads used weekly
The weekly consumption of urine pads was assessed in participants.
Time frame: Week 4, 6, 18, 30, 42 and 54
Incidence of adverse events
Observe the incidence of adverse events during the treatment.
Time frame: Week 1-6
Evaluation of discomfort during treatment
Visual analog scale (VAS) will be used to evaluate the degree of discomfort during treatment. The scale ranging from 0 to 10cm, with 0cm indicating no discomfort and 10cm indicating severe discomfort. Evaluation time: The average value of the first and ninth acupuncture treatments was taken within 5 minutes after the end of the two treatments. If the VAS value is missing in one of the cases, another is taken as the result.
Time frame: Within 5 minutes after the first and ninth acupuncture treatment
Patient acceptability evaluation
0=very difficult to accept, 1=slightly difficult to accept, 2=acceptable, 3=easy to accept, 4=very easy to accept. Evaluation time: The average value of the first and ninth acupuncture treatments was taken within 5 minutes after the end of the two treatments. If the VAS value is missing in one of the cases, another is taken as the result.
Time frame: Within 5 minutes after the first and ninth acupuncture treatment
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for Aug 2026, 43 months after the start.
Of 226 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 43 months is above that.
Counting every sponsor, half of 267 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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Urinary Incontinence, Stress →
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