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Observation of the Clinical Effects of Electroacupuncture for Female Mild to Moderate Stress Urinary Incontinence Based on Pelvic Floor Functional Structure and Electromyographic Changes

Registration number：

ITMCTR2024000894

Date of Last Refreshed on：

2024-12-29

Date of Registration：

2024-12-29

Registration Status：

Prospective registration

Public title：

Observation of the Clinical Effects of Electroacupuncture for Female Mild to Moderate Stress Urinary Incontinence Based on Pelvic Floor Functional Structure and Electromyographic Changes

English Acronym：

Scientific title：

Observation of the Clinical Effects of Electroacupuncture for Female Mild to Moderate Stress Urinary Incontinence Based on Pelvic Floor Functional Structure and Electromyographic Changes

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

BingLi Chen

Study leader：

Chen Bingli

Applicant telephone：

13817786969

Study leader's telephone：

13817786969

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1719086552@qq.com

Study leader's E-mail：

1719086552@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

110 Ganhe Road Hongkou District Shanghai

Study leader's address：

110 Ganhe Road Hongkou District Shanghai

Applicant postcode：

200080

Study leader's postcode：

200080

Applicant's institution：

Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024-236

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese medicine

Date of approved by ethic committee：

2024/11/28 0:00:00

Contact Name of the ethic committee：

CongQuan Yin

Contact Address of the ethic committee：

110 Ganhe Road Hongkou District Shanghai

Contact phone of the ethic committee：

+86 65161782

Contact email of the ethic committee：

yyyyllwyh@163.com

Primary sponsor：

Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese medicine

Primary sponsor's address：

110 Ganhe Road Hongkou District Shanghai

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Institution
hospital：

Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese medicine

Address：

110 Ganhe Road Hongkou District Shanghai

Source(s) of funding：

Traditional Chinese Medicine Research Project of Shanghai Municipal Health Commission

Target disease：

Stress Urinary Incontinence

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Using a multicenter large-sample randomized controlled method 206 female patients with stress urinary incontinence (SUI) were randomly divided into two groups: Pelvic Floor Muscle Training (PFMT) + electroacupuncture group and PFMT + sham electroacupuncture group. The study utilized indicators such as 1-hour pad test urine leakage ICIQ-SF questionnaire 72-hour urinary incontinence episodes and patient subjective efficacy evaluation. Additionally it combined multi-dimensional pelvic ultrasound and pelvic muscle electromyography technology to analyze the changes in pelvic floor functional structure of SUI patients. The aim is to explore the clinical efficacy and safety of electroacupuncture combined with PFMT for the treatment of SUI to identify the optimal treatment plan and to promote its clinical application.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meets the diagnostic criteria for mild to moderate female stress urinary incontinence (SUI); (2) Aged 40 to 75 years female; (3) Has signed the informed consent form and voluntarily participates in the study.

Exclusion criteria：

(1) Urge urinary incontinence mixed urinary incontinence and overflow incontinence etc.; (2) History of surgical treatment for urinary incontinence or pelvic floor surgery; (3) Genital prolapse of degree ≥2; (4) Symptomatic urinary tract infection; (5) Residual urine >30ml; (6) Maximum urinary flow rate <20ml/s. (7) Inability or limitation in walking climbing stairs or running; (8) Long-term use of medications that may affect bladder function or currently receiving specialized treatment for SUI; (9) Accompanying severe heart brain liver kidney hematopoietic system and mental disorders; (10) Pregnancy or lactation; those with cardiac pacemakers metal allergies or severe needle phobia. (11) Install a pacemaker metal allergy or severe fear of needles.

Study execute time：

From 2024-11-28

To      2026-12-31

Recruiting time：

From 2025-01-01

To      2026-01-01

Interventions：

103

Group：

control group

Sample size：

Intervention：

Sham electroacupuncture combined with pelvic floor muscle training

Intervention code：

103

Group：

Experimental group

Sample size：

Intervention：

Electroacupuncture combined with pelvic floor muscle training.

Intervention code：

Total sample size ： 206

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Longhua Hospital Affiliated to Shanghai University of traditional Chinese medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Xiangshan TCM of Huangpu District of Shanghai

Level of the institution：

Tertiary B

Country：

China

Province：

Shanghai

City：

Institution/hospital：

Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Multidimensional pelvic floor structural changes.

Type：

Secondary indicator

Measure time point of outcome：

Before starting treatment and after completion of treatment

Measure method：

transperineal pelvic floor ultrasound

Outcome：

Average number of urgent urination in 72h

Type：

Secondary indicator

Measure time point of outcome：

Before the start of treatment, 4th, 6th, 18th, and 30th weeks of treatment

Measure method：

3-day urination diary

Outcome：

Patient Subjective Evaluation of Treatment Effectiveness

Type：

Secondary indicator

Measure time point of outcome：

The 4th, 6th, 18th, and 30th weeks of treatment

Measure method：

Four-point method

Outcome：

Average number of incontinence in 24h

Type：

Primary indicator

Measure time point of outcome：

Before starting treatment and after completion of treatment

Measure method：

1-hour urine pad test

Outcome：

International Consultation on Incontinence questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Before the start of treatment, 4th, 6th, 18th, and 30th weeks of treatment

Measure method：

International Consultation on Incontinence Questionnaire - Short Form

Outcome：

Pelvic floor electromyography (PFEMG)

Type：

Secondary indicator

Measure time point of outcome：

Before starting treatment and after completion of treatment

Measure method：

Surface electromyography of pelvic floor muscle

Outcome：

Average weekly pad usage

Type：

Secondary indicator

Measure time point of outcome：

International Consultation on Incontinence questionnaire

Measure method：

1-week pad usage chart

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

40
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Female

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study employed a stratified block randomization method with the center serving as the stratification factor and each center competing for enrollment. The randomization scheme required for the study was generated using the "Proc plan" procedure of the SAS 9.4 statistical analysis software and random allocation cards were created and sealed in opaque envelopes. Cases were assigned to the same numbered envelopes according to the order of their visits. Researchers responsible for randomization at each center allocated eligible subjects to the following two groups in a 1:1 ratio as specified on the cards inside the envelopes: Pelvic Floor Muscle Training (PFMT) + Electroacupuncture group and PFMT + Sham Electroacupuncture group.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Keep private

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form CRF

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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