Stress Urinary IncontinenceNCT05635669
Optimized Acupuncture Treatment for Female Stress Urinary Incontinence
A study testing Sacral acupoints acupuncture, Abdominal acupoints acupuncture and Alternating acupoints acupuncture in people with Stress Urinary Incontinence, run by Yin Ping at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Sacral acupoints acupuncture, Abdominal acupoints acupuncture and Alternating acupoints acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderate SUI mentioned in the diagnostic criteria above;
- Aged 40～75 years;
- Sign the informed consent.
Who cannot join
- Other types of urinary incontinence (urgent, overflow or mixed).
- History of urinary incontinence surgery or pelvic floor surgery;
- Pelvic organ prolapse ≥ stage II;
- Symptomatic urinary tract infection;
- Residual urine volume > 30 mL;
- Maximum urinary flow rate < 20ml/s.
Show all 11Show fewer
- Limitation of movement (walk and/or run and/or climb stairs);
- Patients who have been using drugs that may affect bladder function or receiving SUI specialized treatment;
- Severe cardiovascular, cerebral, liver, kidney and hematopoietic system disease, mental disorders, diabetes, multiple system atrophy, cauda equina neuropathy and spinal cord disease;
- Pregnancy or lactation period.
- With cardiac pacemaker, acupuncture phobia or metal allergies;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai
Yuelai Chen
About this study
Official title: Optimized Acupuncture Treatment for Female Stress Urinary Incontinence: a Study Protocol for a Multicenter Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Sacral acupoints acupuncture, Abdominal acupoints acupuncture, Alternating acupoints acupuncture
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral acupoints acupunctureDevice
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) .
Abdominal acupoints acupunctureDevice
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).
Alternating acupoints acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sacral acupoints group (Sacral group) | Experimental | Participants will receive sacral acupoints combination treatment at bilaterally Huiyang(BL35) and Zhongliao(BL33) with prone position during the whole treatment course. Receives: Device: Sacral acupoints acupuncture |
| Abdominal acupoints group (Abdominal group) | Experimental | 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. Receives: Device: Abdominal acupoints acupuncture |
| Alternating acupoints group (Alternating group) | Experimental | 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. ) Receives: Device: Alternating acupoints acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 6
Secondary outcomes (17)
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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week18, 30, 42 and 54
Number of urine pads used weekly
The weekly consumption of urine pads was assessed in participants.
Measured: Week 4, 6, 18, 30, 42 and 54
Incidence of adverse events
Observe the incidence of adverse events during the treatment.
Measured: 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.
Measured: 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.
Measured: Within 5 minutes after the first and ninth acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start4 Jan 2023
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yin Ping
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital
- Responsible party
- Sponsor-investigator, Yin Ping, Shanghai University of Traditional Chinese Medicine
- Investigators
- YUELAI CHEN, Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635669
- Sponsor's protocol ID
- 22Y21920100
- Status last verified
- May 2025
- First submitted
- 12 Nov 2022
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang N, Ge X, Ye J, Liu Q, Wu Y, Yan H, Han X. Efficacy of acupuncture for urinary incontinence in middle-aged and elderly women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2021 Feb;257:138-143. doi: 10.1016/j.ejogrb.2020.11.001. Epub 2020 Nov 4.
PubMed 33419589Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
PubMed 28655016Nambiar AK, Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence. Eur Urol. 2022 Jul;82(1):49-59. doi: 10.1016/j.eururo.2022.01.045. Epub 2022 Feb 23.
PubMed 35216856Guan LX, Song XL, Wang X, Zhang X, Liu LM, Chen BL, Chen YL. Immediate effects of Zhongji point acupuncture on pelvic floor structure in female patients with stress urinary incontinence: a randomized, single-blind, and sham-controlled clinical trial protocol. Ann Palliat Med. 2021 Jul;10(7):8292-8299. doi: 10.21037/apm-21-662. Epub 2021 Jul 2.
PubMed 34263647Liu L, Chen B, Si X, Hou W, Fan Q, Li X, Li J, Ming S, Yin P, Chen Y. Optimized electroacupuncture treatment for female stress urinary incontinence: study protocol for a multi-center randomized controlled trial. Front Psychiatry. 2023 Aug 17;14:1228131. doi: 10.3389/fpsyt.2023.1228131. eCollection 2023.
PubMed 37663593
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Acupuncture Treatment for Female Stress Urinary Incontinence: a Study Protocol for a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05635669
- Acronym / sponsor ID
- 22Y21920100
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Yin PingUniversity, hospital or other
- Collaborators
- Longhua Hospital
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Dec 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sacral acupoints group (Sacral group) | Experimental | Device: Sacral acupoints acupunctureParticipants will receive sacral acupoints combination treatment at bilaterally Huiyang(BL35) and Zhongliao(BL33) with prone position during the whole treatment course. |
| Abdominal acupoints group (Abdominal group) | Experimental | Device: Abdominal acupoints acupunctureParticipants will receive abdominal acupoints combination treatment at unilateral Zhongji(RN3), Guanyuan(RN4) and bilaterally Dahe(KI12) with dorsal position during the whole treatment course. |
| Alternating acupoints group (Alternating group) | Experimental | Device: Alternating acupoints acupunctureParticipants 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. ) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with mild to moderate SUI mentioned in the diagnostic criteria above;
- Aged 40～75 years;
- Sign the informed consent.
Key exclusion criteria (11 listed)
- Other types of urinary incontinence (urgent, overflow or mixed).
- History of urinary incontinence surgery or pelvic floor surgery;
- Pelvic organ prolapse ≥ stage II;
- Symptomatic urinary tract infection;
- Residual urine volume > 30 mL;
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 |
|---|---|---|
| Sacral acupoints acupunctureBefore 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) . | Device | Sacral acupoints group (Sacral group) |
| Abdominal acupoints acupunctureBefore 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). | Device | Abdominal acupoints group (Abdominal group) |
| Alternating acupoints acupunctureBefore 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. | Device | Alternating acupoints group (Alternating group) |
Primary outcome
The change of urine leakage measured by the 1-hour pad test
Time frame: Week 6
Quantity of fluid loss will be measured by 1-hour pad test, compared with the baseline (week 0).
17 secondary outcomes
The change of mean episodes of urinary incontinence in 72 hours
Time frame: Week 4, 6, 18, 30, 42 and 54
The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Week 4, 6, 18, 30, 42 and 54
Severity of SUI according to '72 hours bladder diary'
Time frame: Week 4, 6, 18, 30, 42 and 54
Participant Self-evaluation of Therapeutic Effects
Time frame: Week 4, 6, 18, 30, 42 and 54
The number of patients who used other treatment for SUI
Time frame: Week 18, 30, 42 and 54
Bladder neck mobility by pelvic floor ultrasonography
Time frame: Week 6
Urethral rotation angle by pelvic floor ultrasonography
Time frame: Week 6
Retrovesical angle by pelvic floor ultrasonography
Time frame: Week 6
Lowest point of bladder by pelvic floor ultrasonography
Time frame: Week 6
Urethral funnel formation by pelvic floor ultrasonography
Time frame: Week 6
The type of bladder bulging by pelvic floor ultrasonography
Time frame: Week 6
Subgroup analysis: 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
Time frame: Week18, 30, 42 and 54
Number of urine pads used weekly
Time frame: Week 4, 6, 18, 30, 42 and 54
Incidence of adverse events
Time frame: Week 1-6
Evaluation of discomfort during treatment
Time frame: Within 5 minutes after the first and ninth acupuncture treatment
Patient acceptability evaluation
Time frame: Within 5 minutes after the first and ninth acupuncture treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Background: PubMed 33419589Yang N, Ge X, Ye J, Liu Q, Wu Y, Yan H, Han X. Efficacy of acupuncture for urinary incontinence in middle-aged and elderly women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2021 Feb;257:138-143. doi: 10.1016/j.ejogrb.2020.11.001. Epub 2020 Nov 4.
- Background: PubMed 28655016Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
- Background: PubMed 35216856Nambiar AK, Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence. Eur Urol. 2022 Jul;82(1):49-59. doi: 10.1016/j.eururo.2022.01.045. Epub 2022 Feb 23.
- Background: PubMed 34263647Guan LX, Song XL, Wang X, Zhang X, Liu LM, Chen BL, Chen YL. Immediate effects of Zhongji point acupuncture on pelvic floor structure in female patients with stress urinary incontinence: a randomized, single-blind, and sham-controlled clinical trial protocol. Ann Palliat Med. 2021 Jul;10(7):8292-8299. doi: 10.21037/apm-21-662. Epub 2021 Jul 2.
- Derived from this study: PubMed 37663593Liu L, Chen B, Si X, Hou W, Fan Q, Li X, Li J, Ming S, Yin P, Chen Y. Optimized electroacupuncture treatment for female stress urinary incontinence: study protocol for a multi-center randomized controlled trial. Front Psychiatry. 2023 Aug 17;14:1228131. doi: 10.3389/fpsyt.2023.1228131. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
YUELAI CHEN principal investigator
Longhua 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 Sacral acupoints acupuncture, Abdominal acupoints acupuncture and Alternating acupoints acupuncture in people with Stress Urinary Incontinence, run by Yin Ping 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PING YIN (086-18917561621, bingxue616@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of urine leakage measured by the 1-hour pad test (time frame: Week 6). 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 NCT05635669, which also lists 5 linked publications.
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 22 May 2025.