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Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Biofeedback electrical stimulation
Acupuncture
Acupuncture combined with biofeedback electrical stimulation
Sponsored by
Hebei General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress urinary incontinence, Acupuncture, Biofeedback electrical stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Caiqing Ji

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Biofeedback electrical stimulation

Acupuncture

Acupuncture combined with biofeedback electrical stimulation

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2022
Last Updated
September 5, 2022
Sponsor
Hebei General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05531071
Brief Title
Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI
Official Title
Clinical Observation of Acupuncture Combined With Biofeedback Electrical Stimulation in the Treatment of Female Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
January 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress urinary incontinence, Acupuncture, Biofeedback electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback electrical stimulation
Arm Type
Active Comparator
Arm 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.
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm 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.
Arm Title
Acupuncture combined with biofeedback electrical stimulation
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Biofeedback electrical stimulation
Intervention Description
treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
acupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times.
Intervention Type
Combination Product
Intervention Name(s)
Acupuncture combined with biofeedback electrical stimulation
Intervention Description
treated with acupuncture combined with biofeedback electrical stimulation.
Primary Outcome Measure Information:
Title
Pelvic floor muscle strength
Description
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.
Time Frame
Before treatment
Title
Pelvic floor muscle strength
Description
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.
Time Frame
4 weeks
Title
1 hours urine pad test
Description
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.
Time Frame
Before treatment
Title
1 hours urine pad test
Description
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.
Time Frame
4 weeks
Title
International Consultation on Incontinence Questionnaire short form
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Caiqing Ji
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI

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