PERIPHERAL TRANSCUTANEOUS NEUROMODULATION OF THE POST-TIBIAL NERVE (T-PTNS) FOR SOLIFENACIN 10mg. IN THE TREATMENT OF HYPERACTIVE BLADDER SYNDROME: NON-INFERIORITY PHASE IV RANDOMIZED CLINICAL TRIAL - SoliTens

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia0 个研究点开始时间: 2017年5月29日最近更新: 2017年8月21日

试验速览

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•Women> 18 years, diagnosed with SVHI for at least 6 months of evolution and who have taken Beta 3 agonists.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•1) Patients who can contribute biased information: have previously consumed and abandoned anticholinergic drugs due to lack of efficacy or side effects; Suffering from overactive bladder of neurogenic origin (multiple sclerosis, Parkinson's, spinal cord injury); Present cystocele or any prolapse of pelvic organs grade> 2 according to POP-Q classification (39).
•2) Patients who may become worse with the interventions envisaged in the study: being a pacemaker-ICD; Who can not take anticholinergics (for hypersensitivity, megacolon, myasthenia gravis, narrow-angle glaucoma); With cutaneous alterations in lower extremities that prevent the placement of electrodes on the surface; Pregnant women or who may be pregnant during the duration of the clinical trial ..

发起方

Fundación para la Formación e Investigación Sanitarias de la Región de Murcia