IPSU study: Impact of Physiotherapy on Sexual function in women with Stress Urinary Incontinence (SUI) and a comparison of electrical stimulation versus standard physiotherapy: a randomised controlled trial

Sheffield Teaching Hospitals NHS Trust (UK)0 个研究点目标入组 114 人开始时间: 2013年5月3日最近更新: 2017年11月20日

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•1. Women aged 18-60 years must have given written (personally signed and dated) informed consent
•2. Women who are able to understand, and are willing to comply with the requirements of the protocol
•3. Women who are sexually active and are between the age of 18yrs and with urinary incontinence attending physiotherapy for pelvic floor muscle training (PFMT)
•4. Women who score either greater than 25% on the urinary domain of the sexual function dimension, and/or greater than 33% for the degree of bother for the same symptom

•1. Women with a prolapse as their predominant problem
•2. Women who have had any previous incontinence surgery
•3. Women who have a Grade 3 or above muscle strength as measured using the modified Oxford Scale on vaginal examination
•4. Women with vaginal discharge or UTI
•5. Women fitted with an implanted pacemaker
•6. Women who are pregnant
•7. Women with undiagnosed pelvic pain
•8. Women with a known sensitivity to the electrodes or the electrode gel
•9. Women with inflammation or infection of the vulva and vagina
•10. Women who have experienced recent haemorrhage or haematoma
•11. Women with atrophic vaginitis
•12. Any other medical condition or abnormality (e.g. Malignancy or complication) that in the opinion of the investigator would impact upon the safety or efficacy of the study treatment or any study assessments
•13. The patient is enrolled in another interventional trial
•14. Non-English speaking women or with a specific language problem

发起方

Sheffield Teaching Hospitals NHS Trust (UK)