ISRCTN32312996
Completed
未知
A single-blind multicentre, controlled, randomised, blinded comparative study of three forms of pelvic floor muscle training: kegel exercises (KE), electrical stimulation using external skin-electrodes (ESEX) and electrical stimulation using an intra-vaginal electrode (ESIN), in the treatment of stress urinary incontinence
orth Georgia College and State University (USA)0 sites243 target enrollmentMarch 25, 2010
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Stress urinary incontinence
- Sponsor
- orth Georgia College and State University (USA)
- Enrollment
- 243
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Referrals with significant stress urinary incontinence (SUI) (defined as greater than 3 leaks/day or greater than 3 g in cough/jumping jack test) of any ethnic background
- •2\. Pre\-screened and cleared by gynaecological/urologist/suitably experienced PT for structural abnormalities (e.g. prolapsed uterus)
- •3\. Body mass index (BMI) less than 40 kg/m^2
- •4\. Non\-smoker
- •5\. Greater than 3 months post\-partum
- •6\. Females at least 18 and less than 70 years of age
- •7\. Able to comply with either therapy
- •8\. Able and willing to complete all of the study and provide informed written consent prior to entering the study
Exclusion Criteria
- •1\. Persons contra\-indicated for ES
- •2\. Individuals with a history of an underlying neurological condition
- •3\. Individuals with an active implanted medical device, e.g., pacemaker or pump
- •4\. Pregnant women or inadequate precautions to prevent pregnancy
- •5\. Neurological impairment affecting pelvic floor musculature
- •6\. Medication affecting continence
- •7\. Medication for high blood pressure
- •8\. Previous incontinence surgery, hysterectomy, previous gynaecological related surgery
- •9\. Intra\-uterine devices (IUDs) or metal implants in the pelvic area, including hip
- •10\. Clinical diagnosis of prolapse
Outcomes
Primary Outcomes
Not specified
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