- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531071
Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI
September 5, 2022 updated by: Caiqing Ji, Hebei General Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050000
- Caiqing Ji
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Biofeedback electrical stimulation
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.
|
treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times.
|
Active Comparator: Acupuncture
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.
|
acupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times.
|
Experimental: Acupuncture combined with biofeedback electrical stimulation
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.
|
treated with acupuncture combined with biofeedback electrical stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before treatment
|
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.
|
4 weeks
|
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.
|
Before treatment
|
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.
|
4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2020
Primary Completion (Actual)
January 12, 2021
Study Completion (Actual)
January 12, 2021
Study Registration Dates
First Submitted
August 31, 2022
First Submitted That Met QC Criteria
September 5, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Actual)
September 7, 2022
Last Update Submitted That Met QC Criteria
September 5, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HebeiGH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress Urinary Incontinence
-
University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
-
Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
-
Hadassah Medical OrganizationCompletedUrinary Stress Incontinence (SI)Israel
-
University Magna GraeciaUnknownStress Urinary IncontinenceItaly
-
University of California, IrvineWithdrawnStress Urinary IncontinenceUnited States
-
Eli Lilly and CompanyBoehringer IngelheimCompleted
-
Eli Lilly and CompanyBoehringer IngelheimCompletedUrinary Stress IncontinenceUnited States
Clinical Trials on Biofeedback electrical stimulation
-
Badr UniversityCompletedFecal Incontinence in ChildrenEgypt
-
VivaltisCEISO; Human PhysioNot yet recruiting
-
National Institute of Diabetes and Digestive and...Completed
-
Azienda Ospedaliero Universitaria Maggiore della...Unknown
-
Far Eastern Memorial HospitalRecruitingStress Urinary Incontinence | Urethral Hypermobility | Intrinsic Sphincter DeficiencyTaiwan
-
VivaltisCEISO; Human Physio; Pôle santé de la NartassièreNot yet recruitingUrinary Incontinence | Pelvic Floor DisordersFrance
-
Clinical Hospital Centre ZagrebRecruitingOsteoarthritis, KneeCroatia
-
Mackay Memorial HospitalRecruitingPelvic Organ Prolapse | IncontinenceTaiwan
-
Aesyra SARecruiting
-
National Yang Ming UniversityCompleted