Simple Stress Urinary Incontinence Clinical Trial
Official title:
The Efficacy of Electroacupuncture for Treatment of Simple Female Stress Urinary Incontinence: Comparison With Pelvic Floor Muscle Training-a Multicenter Randomized Controlled Trial
This research is primarily to compare effectiveness of electroacupuncture and pelvic floor muscle training for SUI, and evaluate optimal efficiency of electroacupuncture for stress urinary incontinence (SUI). The early clinical research is a randomized controlled trial (RCT) with a small sample,consisting of two arms of electroacupuncture group and sham electroacupuncture group to value difference of extent of SUI in 1h pad test after 4 weeks. The result indicates that electroacupuncture is an optimal method for SUI. As a further study, this research is a large sample multicenter trial with two parallel arms of electroacupuncture group and pelvic floor muscle training group. The primary purpose is to value effectiveness of electroacupuncture for SUI in aspect of frequency of leakage and amount of leakage, comparing with pelvic floor muscle training. And the secondary purpose is to evaluate safety of electroacupuncture therapy, and compare acceptance of electroacupuncture treatment and pelvic floor muscle training.
| Status | Recruiting |
| Enrollment | 320 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Meet the diagnosis of Simple female stress urinary incontinence - 40-75 years old - Volunteered to join this research and signed the informed consent Exclusion Criteria: - Urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence, etc - After operation for urinary incontinence or pelvic floor operation - Edeoptosis>Degree 2 - Symptomatic urinary tract infection - Residual urine volume>30m1 - Qmax<20m1/s - Constrained movement of walking, stairs climbing, running - Patients with continuous treatment for stress urinary incontinence or medicine for bladder function .With serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, multiple system atrophy, Injury of cauda equine,myeleterosis. - During pregnancy or lactation period - With cardiac pacemaker, Metal allergy or severe needle phobia - Senile dementia - Lunatic |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Shaanxi Hospital of Traditional Chinese Medicine | Xi'an | Shaanxi |
| China | Tongsheng Su | Xi'an | Shaanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Shaanxi Hospital of Traditional Chinese Medicine | Ministry of Science and Technology of the People´s Republic of China |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference of frequency of leakage in mean 24h based on 72h diary, compared with the baseline | Since the average frequency difference of urinary incontinence in mean 24h of the 8th week is the average frequency difference of urinary incontinence in mean 24h of 2nd, 4th, 6th, 8th weeks based on the "72 voiding diary", which is 12 times treatment totally. Therefore, frequency of leakage in mean 24h is calculated by total frequency of leakage in week of 2th , 4th, 6th and 8th divided 12. | the 2, 4, 6, 8 week | No |
| Primary | Difference of amount of leakage in mean 24h based on 72h diary, compared with the baseline | The quantity of fluid loss in mean 24h will be measured by "72h voiding diary", comparing the value of 2nd, 4th, 6th and 8th weeks with the baseline (0 week) in 8th week. And the quantity of fluid loss in mean 24h is calculated by total quantity of fluid loss of 12 times treatment divided 12. | the 2, 4, 6, 8 week | No |
| Secondary | Difference of 1h pad test, compared with the baseline | Quantity of fluid loss will be measured by 1 h pad test, comparing the value of 2nd and 6th week with the baseline(0 week), the primary outcome is the value difference. | the 8, 20, 32 week | No |
| Secondary | ICIQ-SF | International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a brief instrument used to assess the impact of UI in patients'lives | the 8, 20, 32 week | No |
| Secondary | Patient subjective effectiveness evaluation | 3 point scoring: no help=0; Small help=1;Medium help=2; Great help=3 | the 8, 20, 32 week | No |
| Secondary | Weekly usage of pad | The value of 8th week is the average weekly usage of pads during 1-8 weeks ; The value of 20th week is the average weekly usage of pads during 9-20 weeks; The value of 32th week is the average weekly usage of pads during 21-32 weeks. | the 8, 20, 32 week | No |
| Secondary | Usage of specialty therapy for Simple female stress urinary incontinence | Compare the difference of uase of specialty therapy for Simple female stress urinary incontinence between the 2 groups during the 1-8 weeks, 9-20 weeks and 21-32 weeks. | the 8, 20, 32 week | No |
| Secondary | Subgroup analysis: amount of leakage with 1h pad test as a measure of curative effect of electroacupuncture for different extent of simple female stress urinary incontinence. | The 8th week: difference of 1 h pad test for simple female stress urinary incontinence, compared with the baseline; the 20th and 32th weeks: difference of 1h pad test for simple female stress urinary incontinence, compared with the baseline. | the 8, 20, 32 week | No |