Optimized acupuncture for female stress urinary incontinence

Optimized Acupuncture Treatment for Female Stress Urinary Incontinence: a Study Protocol for a Multicenter Randomized Controlled Trial

This study is testing different acupuncture methods to see if they can help women with stress urinary incontinence feel better and reduce their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 40 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05635669 on ClinicalTrials.gov

What this trial studies

This multicenter randomized controlled trial aims to evaluate the effectiveness of different acupoint combinations in treating female stress urinary incontinence (SUI). Participants will be divided into three groups, each receiving a distinct acupuncture treatment targeting either sacral, abdominal, or alternating acupoints. The study seeks to provide clinical evidence for optimizing acupuncture techniques to alleviate symptoms of SUI, which affects a significant portion of women globally. By measuring outcomes such as urine leakage and quality of life improvements, the trial will contribute to understanding acupuncture's role in managing this condition.

Who should consider this trial

Good fit: Ideal candidates are women aged 40 to 75 with mild to moderate stress urinary incontinence.

Not a fit: Patients with other types of urinary incontinence or those who have undergone previous surgeries for urinary incontinence may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce urinary leakage and improve the quality of life for women suffering from stress urinary incontinence.

How similar studies have performed: Previous studies have shown that acupuncture can effectively reduce symptoms of urinary incontinence, suggesting potential success for this optimized approach.

Eligibility criteria

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;

Where this trial is running

Shanghai

• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Yuelai Chen — Shanghai University of Traditional Chinese Medicine
• Study coordinator: Ping Yin

Conditions Stress Urinary Incontinence