Stress Urinary IncontinenceNCT05531071
Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI
A study testing Biofeedback electrical stimulation, Acupuncture and Acupuncture combined with biofeedback electrical stimulation in people with Stress Urinary Incontinence, run by Hebei General Hospital at 1 site in China.
Trial summary
Objective: To investigate the clinical efficacy of acupuncture combined with biofeedback electrical stimulation on female stress urinary incontinence. Methods: 90 patients diagnosed in a hospital from January 2020 to January 2021 were randomly divided into three groups A, B and C, and group A was treated with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Biofeedback electrical stimulation, Acupuncture and Acupuncture combined with biofeedback electrical stimulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2020to 12 Jan 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet the diagnostic criteria of SUI
- Aged over 18 years old and have a history of sexual life
- No treatment related to SUI within three months
- Mental illness without cognitive dysfunction, able to cooperate with examination and treatment
- Voluntarily participate and sign the informed consent
Who cannot join
- combined with urge urinary incontinence, uterine prolapse, vaginal anterior and posterior wall prolapse
- pregnancy, postpartum lochia or abnormal vaginal bleeding
- Acute phase of inflammation (pelvic cavity, vagina, urinary system)
- There are metal substances such as pacemakers and metal stents in the body
- Denervation of pelvic floor muscles (no sensation, no contraction)
- coagulation dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Observation of Acupuncture Combined With Biofeedback Electrical Stimulation in the Treatment of Female Stress Urinary Incontinence
Objective: To investigate the clinical efficacy of acupuncture combined with biofeedback electrical stimulation on female stress urinary incontinence. Methods: 90 patients diagnosed in a hospital from January 2020 to January 2021 were randomly divided into three groups A, B and C, and group A was treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times. Group B used acupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times. Group C was treated with acupuncture combined with biofeedback electrical stimulation. All three groups were combined with pelvic floor muscle training. After treatment, the changes in class I, II muscle fiber, ICI-Q-SF score, and urine leakage in the 1h pad test were compared.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Biofeedback electrical stimulation, Acupuncture, Acupuncture combined with biofeedback electrical stimulation
- Keywords
- Stress urinary incontinence, Acupuncture, Biofeedback electrical stimulation
- 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.
Biofeedback electrical stimulationDevice
treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times.
AcupunctureProcedure or surgery
acupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times.
Acupuncture combined with biofeedback electrical stimulationCombination product
treated with acupuncture combined with biofeedback electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback electrical stimulation | Active comparator | Use the PHENIX USB4 Pelvic Floor Rehabilitation Therapy Apparatus to enter the Stress Urinary Incontinence Treatment Module. The frequency of electrical stimulation was 50Hz, the pulse width was 250μs, and the current intensity increased from 0mA, generally not exceeding 50mA. For the 1st to 3rd treatments, intermittent bioelectrical stimulation mode was given.For the 4th to 10th treatments, the biofeedback mode with intermittent bioelectrical stimulation was given, and for the 11th to 15th treatments, the simple biofeedback mode was given. 3 times a week, 30 minutes each time, a total of 15 treatments. Instruct the patient to go home to perform pelvic floor muscle training, focusing on anal contractions. Each anal contraction takes 3-5s and relaxes for 5-10s. so repeatedly. 20 minutes each time, 3 times a day in the morning, noon and evening, 5 days a week, until the end of the treatment. Receives: Device: Biofeedback electrical stimulation |
| Acupuncture | Active comparator | A single-use sterile needle of Changchun Aikang brand was selected, with a size of 0.30 mm × 40 mm. Ding points: Guanyuan point, Qihai point, Zhongji point, Zusanli point, Sanyinjiao point, Yinlingquan point. Routine disinfection of the patient's skin is performed, and Guanyuan, Qihai, and Zhongji points are punctured obliquely downward, and the needle is inserted 1-1.2 cun; evenly lift, insert and twist to get qi. At the same time, the moxa column was ignited and placed in the moxibustion box, and the moxibustion box was placed above the three points of Guanyuan, Qihai, and Zhongji in the patient's abdomen, and the moxibustion was performed until the skin was red and the deep tissue was heated. 1 time a day, every Monday to Friday, 30 minutes each time, 10 times as a course of treatment. The patients were instructed to go home for pelvic floor muscle training, and the method was the same as that of group Biofeedback electrical stimulation. Receives: Procedure: Acupuncture |
| Acupuncture combined with biofeedback electrical stimulation | Experimental | Biofeedback electrical stimulation therapy combined with acupuncture and moxibustion were given to the patients. After 10 sessions of acupuncture, continue the unfinished biofeedback electrical stimulation treatment. The patients were instructed to go home for pelvic floor muscle training, and the method was the same as that of group Biofeedback electrical stimulation. Receives: Combination Product: Acupuncture combined with biofeedback electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength
Use the French Sugiyama PHENIX USB2 pelvic floor rehabilitation therapy instrument to detect the muscle strength of pelvic floor type I muscle fibers and type II muscle fibers. Class I muscle strength: amplitude height ≥ 40%, duration 0-5s corresponds to 0-5 level muscle strength; Class II muscle strength: Amplitude height ≥ 60%, 0 to 5 times of duration corresponds to 0 to 5 levels of muscle strength.
Measured: Before treatment
Pelvic floor muscle strength
Use the French Sugiyama PHENIX USB2 pelvic floor rehabilitation therapy instrument to detect the muscle strength of pelvic floor type I muscle fibers and type II muscle fibers. Class I muscle strength: amplitude height ≥ 40%, duration 0-5s corresponds to 0-5 level muscle strength; Class II muscle strength: Amplitude height ≥ 60%, 0 to 5 times of duration corresponds to 0 to 5 levels of muscle strength.
Measured: 4 weeks
1 hours urine pad test
the patient empties the bladder before the test, and the urine pad is weighed and placed in the perineum. 0-15minutes, the patient drinks the mineral water prepared in advance; 16-45minutes, the patient walks as usual, going up and down the stairs; 46-60minutes, the patient runs on the spot for 1 minutes, sits up continuously, coughs forcefully 10 times, and bends over Take the action 5 times, and finally wash your hands with tap water for 1 minutes. After 1hours, the patient was instructed to take out the urine pad and weigh it, retain the urine and measure the urine volume. Urine leakage ≥ 2g is positive; according to the amount of urine leakage, the degree of urinary incontinence can be divided: 2g≤urine leakage <5g is mild, 5≤urine leakage <10g is moderate, 10g≤urine leakage <50g is severe, Urine leakage ≥ 50g is considered extremely severe.
Measured: Before treatment
1 hours urine pad test
the patient empties the bladder before the test, and the urine pad is weighed and placed in the perineum. 0-15minutes, the patient drinks the mineral water prepared in advance; 16-45minutes, the patient walks as usual, going up and down the stairs; 46-60minutes, the patient runs on the spot for 1 minutes, sits up continuously, coughs forcefully 10 times, and bends over Take the action 5 times, and finally wash your hands with tap water for 1 minutes. After 1hours, the patient was instructed to take out the urine pad and weigh it, retain the urine and measure the urine volume. Urine leakage ≥ 2g is positive; according to the amount of urine leakage, the degree of urinary incontinence can be divided: 2g≤urine leakage <5g is mild, 5≤urine leakage <10g is moderate, 10g≤urine leakage <50g is severe, Urine leakage ≥ 50g is considered extremely severe.
Measured: 4 weeks
International Consultation on Incontinence Questionnaire short form
The patients reviewed their situation in the last 4 weeks, and scored three questions: the frequency of urine leakage, the amount of urine leakage, and the degree of impact on daily life. The minimum and maximum values were 0 and 21 respectively. The higher the total score, the more severe the symptoms of urinary incontinence, worse outcome. The greater the impact on life.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start6 Jan 2020
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caiqing Ji, Hebei General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531071
- Sponsor's protocol ID
- HebeiGH
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Acupuncture Combined With Biofeedback Electrical Stimulation in the Treatment of Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05531071
- Acronym / sponsor ID
- HebeiGH
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, Acupuncture, Biofeedback electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hebei General HospitalUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 7 Sep 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.
Objective: To investigate the clinical efficacy of acupuncture combined with biofeedback electrical stimulation on female stress urinary incontinence. Methods: 90 patients diagnosed in a hospital from January 2020 to January 2021 were randomly divided into three groups A, B and C, and group A was treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times. Group B used acupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times. Group C was treated with acupuncture combined with biofeedback electrical stimulation. All three groups were combined with pelvic floor muscle training. After treatment, the changes in class I, II muscle fiber, ICI-Q-SF score, and urine leakage in the 1h pad test were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biofeedback electrical stimulation | Active comparator | Device: Biofeedback electrical stimulationUse the PHENIX USB4 Pelvic Floor Rehabilitation Therapy Apparatus to enter the Stress Urinary Incontinence Treatment Module. The frequency of electrical stimulation was 50Hz, the pulse width was 250μs, and the current intensity increased from 0mA, generally not exceeding 50mA. For the 1st to 3rd treatments, intermittent bioelectrical stimulation mode was given.For the 4th to 10th treatments, the biofeedback mode with intermittent bioelectrical stimulation was given, and for the 11th to 15th treatments, the simple biofeedback mode was given. 3 times a week, 30 minutes each time, a total of 15 treatments. Instruct the patient to go home to perform pelvic floor muscle training, focusing on anal contractions. Each anal contraction takes 3-5s and relaxes for 5-10s. so repeatedly. 20 minutes each time, 3 times a day in the morning, noon and evening, 5 days a week, until the end of the treatment. |
| Acupuncture | Active comparator | Procedure: AcupunctureA single-use sterile needle of Changchun Aikang brand was selected, with a size of 0.30 mm × 40 mm. Ding points: Guanyuan point, Qihai point, Zhongji point, Zusanli point, Sanyinjiao point, Yinlingquan point. Routine disinfection of the patient's skin is performed, and Guanyuan, Qihai, and Zhongji points are punctured obliquely downward, and the needle is inserted 1-1.2 cun; evenly lift, insert and twist to get qi. At the same time, the moxa column was ignited and placed in the moxibustion box, and the moxibustion box was placed above the three points of Guanyuan, Qihai, and Zhongji in the patient's abdomen, and the moxibustion was performed until the skin was red and the deep tissue was heated. 1 time a day, every Monday to Friday, 30 minutes each time, 10 times as a course of treatment. The patients were instructed to go home for pelvic floor muscle training, and the method was the same as that of group Biofeedback electrical stimulation. |
| Acupuncture combined with biofeedback electrical stimulation | Experimental | Combination Product: Acupuncture combined with biofeedback electrical stimulationBiofeedback electrical stimulation therapy combined with acupuncture and moxibustion were given to the patients. After 10 sessions of acupuncture, continue the unfinished biofeedback electrical stimulation treatment. The patients were instructed to go home for pelvic floor muscle training, and the method was the same as that of group Biofeedback electrical stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- meet the diagnostic criteria of SUI
- Aged over 18 years old and have a history of sexual life
- No treatment related to SUI within three months
- Mental illness without cognitive dysfunction, able to cooperate with examination and treatment
- Voluntarily participate and sign the informed consent
Key exclusion criteria (6 listed)
- combined with urge urinary incontinence, uterine prolapse, vaginal anterior and posterior wall prolapse
- pregnancy, postpartum lochia or abnormal vaginal bleeding
- Acute phase of inflammation (pelvic cavity, vagina, urinary system)
- There are metal substances such as pacemakers and metal stents in the body
- Denervation of pelvic floor muscles (no sensation, no contraction)
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 |
|---|---|---|
| Biofeedback electrical stimulationtreated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times. | Device | Biofeedback electrical stimulation |
| Acupunctureacupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times. | Procedure or surgery | Acupuncture |
| Acupuncture combined with biofeedback electrical stimulationtreated with acupuncture combined with biofeedback electrical stimulation. | Combination product | Acupuncture combined with biofeedback electrical stimulation |
Primary outcome
Pelvic floor muscle strength
Time frame: Before treatment
Use the French Sugiyama PHENIX USB2 pelvic floor rehabilitation therapy instrument to detect the muscle strength of pelvic floor type I muscle fibers and type II muscle fibers. Class I muscle strength: amplitude height ≥ 40%, duration 0-5s corresponds to 0-5 level muscle strength; Class II muscle strength: Amplitude height ≥ 60%, 0 to 5 times of duration corresponds to 0 to 5 levels of muscle strength.
Pelvic floor muscle strength
Time frame: 4 weeks
Use the French Sugiyama PHENIX USB2 pelvic floor rehabilitation therapy instrument to detect the muscle strength of pelvic floor type I muscle fibers and type II muscle fibers. Class I muscle strength: amplitude height ≥ 40%, duration 0-5s corresponds to 0-5 level muscle strength; Class II muscle strength: Amplitude height ≥ 60%, 0 to 5 times of duration corresponds to 0 to 5 levels of muscle strength.
1 hours urine pad test
Time frame: Before treatment
the patient empties the bladder before the test, and the urine pad is weighed and placed in the perineum. 0-15minutes, the patient drinks the mineral water prepared in advance; 16-45minutes, the patient walks as usual, going up and down the stairs; 46-60minutes, the patient runs on the spot for 1 minutes, sits up continuously, coughs forcefully 10 times, and bends over Take the action 5 times, and finally wash your hands with tap water for 1 minutes. After 1hours, the patient was instructed to take out the urine pad and weigh it, retain the urine and measure the urine volume. Urine leakage ≥ 2g is positive; according to the amount of urine leakage, the degree of urinary incontinence can be divided: 2g≤urine leakage <5g is mild, 5≤urine leakage <10g is moderate, 10g≤urine leakage <50g is severe, Urine leakage ≥ 50g is considered extremely severe.
1 hours urine pad test
Time frame: 4 weeks
the patient empties the bladder before the test, and the urine pad is weighed and placed in the perineum. 0-15minutes, the patient drinks the mineral water prepared in advance; 16-45minutes, the patient walks as usual, going up and down the stairs; 46-60minutes, the patient runs on the spot for 1 minutes, sits up continuously, coughs forcefully 10 times, and bends over Take the action 5 times, and finally wash your hands with tap water for 1 minutes. After 1hours, the patient was instructed to take out the urine pad and weigh it, retain the urine and measure the urine volume. Urine leakage ≥ 2g is positive; according to the amount of urine leakage, the degree of urinary incontinence can be divided: 2g≤urine leakage <5g is mild, 5≤urine leakage <10g is moderate, 10g≤urine leakage <50g is severe, Urine leakage ≥ 50g is considered extremely severe.
International Consultation on Incontinence Questionnaire short form
Time frame: 4 weeks
The patients reviewed their situation in the last 4 weeks, and scored three questions: the frequency of urine leakage, the amount of urine leakage, and the degree of impact on daily life. The minimum and maximum values were 0 and 21 respectively. The higher the total score, the more severe the symptoms of urinary incontinence, worse outcome. The greater the impact on life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback electrical stimulation, Acupuncture and Acupuncture combined with biofeedback electrical stimulation in people with Stress Urinary Incontinence, run by Hebei General Hospital 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 7 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle strength (time frame: Before treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2022.