Treatment effects of an electro-acupuncture therapy on stress urinary incontinence
- Conditions
- Stress urinary incontinence (SUI)Urological and Genital Diseases
- Registration Number
- ISRCTN39805172
- Lead Sponsor
- uohu Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 156
1. Female patients aged 30–75 years
2. Patients with symptoms conforming to the diagnosis standards of mild and moderate SUI
3. Patients conforming to the syndrome differentiation standards of urinary incontinence caused by kidney qi deficiency
4. Patients with normal routine examination results including those for urine and negative urine culture tests
1. Patients with urge urinary incontinence or mixed urinary incontinence
2. Patients with a medical history of surgical treatment for urinary incontinence or pelvic surgery
3. Patients with uterine prolapse severity =Grade 2
4. Patients with symptomatic urinary system infection
5. Patients with residual urine volumes >30 ml
6. Patients with maximum uroflow rates <20 ml/s
7. Patients incapable of or with restricted capacity for walking, going upstairs/downstairs or running
8. Patients taking drugs that may affect their bladder function or receiving specific SUI treatment
9. Patients with SUI combined with multiple system atrophy, cauda equina lesions or myeleterosis
10. Patients who were pregnant or lactating
11. Patients fitted with cardiac pacemakers, sensitive to metals or with severe enetophobia
12. Patients with pelvic prolapse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measured at 6 weeks of treatment and 3 months follow up after treatment:<br>1. Basic patient information (age, height, body mass index, educational level, past medical history and delivery mode) measured using questionnaires<br>2. 1-hour pad test results measured by pad test
- Secondary Outcome Measures
Name Time Method 1. 1-hour pad test results measured by pad test at 2 weeks 4 weeks, 6 weeks of treatment and 18 weeks follow up after treatment<br>2. Times of urinary incontinence measured using International Consultation on Incontinence Questionnaire—Short Form (ICI-Q-SF) scores before treatment, during the 1-6 weeks of treatment and at 15-18 weeks follow up after treatment<br>3. Quality of life measured using Incontinence Quality of Life Instrument (I-QOL) scores before treatment, during the 1-6 weeks of treatment and at 15-18 weeks follow up after treatment<br>4. 72-hour urinary incontinence frequencies measured using pad test before treatment, during the 1-6 weeks of treatment and at 15-18 weeks follow up after treatment<br>5. Average pad usage per week measured using pad test before treatment, during the 1-6 weeks of treatment and at 15-18 weeks follow up after treatment