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 TRIA
- Conditions
- Overactive Bladder SyndromeTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2017-000605-20-ES
- Lead Sponsor
- Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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 ..
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method