Optimized Acupuncture Treatment for Female Stress Urinary Incontinence

Yin Ping

Status: Enrolling

Conditions: Stress Urinary Incontinence

Treatments: Device: Alternating acupoints acupuncture; Device: Sacral acupoints acupuncture; Device: Abdominal acupoints acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05635669

22Y21920100

Details and patient eligibility

About

This multicenter randomized controlled trial is designed to explore a relatively suitable application of acupoint combinations and to provide certain clinical evidence for the optimization of acupuncture treatment of female SUI.

Full description

Stress urinary incontinence (SUI) mainly refers to the involuntary leakage of urine when abdominal pressure increases, such as sneezing, coughing, laughing or exercise. According to epidemiological studies, the global median prevalence of female urinary incontinence is 27.6% (4.8%-58.4%), of which SUI accounts for more than 50%. Previous study have demonstrated that acupuncture intervention can reduce the urine leakage in pad test, decrease the ICIQ-SF score, so as to help the patients alleviate the symptoms and improve their quality of life. This multicenter randomized controlled trial set 3 groups. Patients will receive 3 different applications of acupoint combinations so that the optimization of acupuncture treatment of female SUI will be find.

Enrollment: 360 estimated patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with mild to moderate SUI mentioned in the diagnostic criteria above;
• Aged 40～75 years;
• Sign the informed consent.

Exclusion criteria

• Other types of urinary incontinence (urgent, overflow or mixed).
• History of urinary incontinence surgery or pelvic floor surgery;
• Pelvic organ prolapse ≥ stage II;
• Symptomatic urinary tract infection;
• Residual urine volume > 30 mL;
• Maximum urinary flow rate < 20ml/s.
• Limitation of movement (walk and/or run and/or climb stairs);
• Patients who have been using drugs that may affect bladder function or receiving SUI specialized treatment;
• Severe cardiovascular, cerebral, liver, kidney and hematopoietic system disease, mental disorders, diabetes, multiple system atrophy, cauda equina neuropathy and spinal cord disease;
• Pregnancy or lactation period.
• With cardiac pacemaker, acupuncture phobia or metal allergies;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 3 patient groups

Sacral acupoints group (Sacral group)

Experimental group

Description:

Participants will receive sacral acupoints combination treatment at bilaterally Huiyang(BL35) and Zhongliao(BL33) with prone position during the whole treatment course.

Treatment:

Device: Sacral acupoints acupuncture

Abdominal acupoints group (Abdominal group)

Experimental group

Description:

Participants will receive abdominal acupoints combination treatment at unilateral Zhongji(RN3), Guanyuan(RN4) and bilaterally Dahe(KI12) with dorsal position during the whole treatment course.

Treatment:

Device: Abdominal acupoints acupuncture

Alternating acupoints group (Alternating group)

Experimental group

Description:

Participants will receive treatment of sacral acupoints combination and abdominal acupoints combination alternately. (For example, A for the first time, B for the second time, A for the third time, and so on. )

Treatment:

Device: Alternating acupoints acupuncture