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Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI

H

Hebei General Hospital

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: Biofeedback electrical stimulation
Procedure: Acupuncture
Combination Product: Acupuncture combined with biofeedback electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05531071
HebeiGH

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Biofeedback electrical stimulation
Active Comparator group
Description:
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.
Treatment:
Device: Biofeedback electrical stimulation
Acupuncture
Active Comparator group
Description:
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.
Treatment:
Procedure: Acupuncture
Acupuncture combined with biofeedback electrical stimulation
Experimental group
Description:
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.
Treatment:
Combination Product: Acupuncture combined with biofeedback electrical stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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