Evaluation of Integrated Optimization Schemes for Female Stress Incontinence (EIOSFSI)

Shanghai Yueyang Integrated Medicine Hospital

Status: Completed

Conditions: Stress Urinary Incontinence in Women

Treatments: Device: Electroacupuncture group; Device: Sham electroacupuncture group; Behavioral: Pelvic floor muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT05053373

ChiCTR-IPR-15006711

2012BAI24B01

Details and patient eligibility

About

The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.

Full description

We will perform a multicenter, randomized, double-blind, sham-controlled, parallel-group clinical trial in four hospitals in China to compare the effectiveness of EA added to PFMT vs sham EA added to PFMT for women with SUI.

The participated women with SUI will be recruited from four participating hospitals or through community clinics by advertising. Participated hospitals include: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (Shanghai, China); Shaanxi Hospital of Traditional Chinese Medicine (Xi'an, China); First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Tianjin, China); and Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine (Nanjing, China).

Patients will be screened for eligibility. Chief complaint, medical history, and general characteristics (such as age, race, education level, body mass index, manner of child delivery, menopause) will be obtained. Those who met inclusion criteria and are interested in participating in the study will sign an informed consent form and then make another appointment to complete the baseline data collection, including the 72-hr bladder diary, 1-h pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, the weekly mean number of urine pads used). Participants will then be assigned randomly to either a PFMT (3 sets/day for 8 weeks) + EA (3 times per week for 8 weeks) group or a PFMT + sham EA group. The primary and secondary outcome will be measured from week 2 to 32. The participant-reported severity of UI and subjective self-evaluation of therapeutic effects will be recorded. Written informed consent will be obtained from all participants before they are included in the study. All clinical investigations will be conducted according to the principles of the Declaration of Helsinki.

Enrollment: 358 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who are 40-75 years of age
• Involuntary leakage of urine during increased intra-abdominal pressure in the absence of a bladder contraction, such as coughing, sneezing, or other physical activities
• a 1-hour pad test exceeds 1 g
• no other treatments are administered for urinary incontinence currently

Exclusion criteria

• Subject has urgency and mixed urinary
• Subjects with pelvic organ prolapse, pregnancy, a history of pelvic surgery, chronic respiratory diseases, urinary tract infection, cardiac pacemaker installation, metal allergy, severe needle fear, and currently taking medications for SUI or psychological disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

358 participants in 2 patient groups

Electroacupuncture Added to Pelvic Floor Muscle Training

Experimental group

Description:

Patients will be in a prone position. Bilateral Zhongliao (BL33) and Huiyangacupoint (BL35) will be identified and punctured by an acupuncturist. The electrodes will be placed on the needle handles, and stimulate for 30 minutes at 50 Hz with a current intensity between 1 to 5 mA. PFMT will be performed 3 sets a day (morning, around noon, and night).

Treatment:

Device: Electroacupuncture group

Behavioral: Pelvic floor muscle training

Sham Electroacupuncture Added to Pelvic Floor Muscle Training

Experimental group

Description:

The preparation for the patients will be the same as that for the patients who will receive EA. Whereas, instead of using real acupuncture needles, special designed placebo needles (size 0.30 × 25 mm) with the blunt-head will be used in the PFMT+sham EA group to penetrate the fixed pad to the skin surface but without skin penetration. The same procedure for deqi will be performed as in the PFMT+EA group. A special-designed cable (the intermediate wire of the cable is cut off but the appearance is normal) will be used to connect the electrodes to the electroacupuncture machine. Therefore, the electroacupuncture machine appears to work, but does not actually stimulated acupoints. The sham EA treatment will also be maintained for 30 minutes. PFMT will be performed 3 sets a day (morning, around noon, and night),

Treatment:

Device: Sham electroacupuncture group

Behavioral: Pelvic floor muscle training