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 个研究点目标入组 243 人开始时间: 2010年3月25日最近更新: 2019年3月25日

适应症

试验速览

暂无简介。

•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

•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
•11. Abnormal Pap smear in the previous 6 months

发起方

orth Georgia College and State University (USA)