Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI

Stress Urinary Incontinence Clinical Trial

Official title:

Clinical Observation of Acupuncture Combined With Biofeedback Electrical Stimulation in the Treatment of Female Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05531071
• Other study ID #: HebeiGH
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: January 12, 2021

Study information

• Verified date: September 2022
• Source: Hebei General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Biofeedback electrical stimulation
treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times.

Procedure:
• Acupuncture
acupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times.

Combination Product:
• Acupuncture combined with biofeedback electrical stimulation
treated with acupuncture combined with biofeedback electrical stimulation.

Locations

Country	Name	City	State
China	Caiqing Ji	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before treatment
Primary	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.	4 weeks
Primary	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.	Before treatment
Primary	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.	4 weeks
Primary	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.	4 weeks