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Completed

NCT Number: NCT05531071

Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofeedback electrical stimulation

Device

treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times.

Acupuncture

Procedure

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 stimulation

Combination Product

treated with acupuncture combined with biofeedback electrical stimulation.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Hebei General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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