Status:
UNKNOWN
Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve for Solifenacin 10 mg. Hyperactive Bladder Syndrome
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
* To determine if the T-PTNS is not inferior in the short term (3 months) to one of the usual pharmacological treatments (Solifenacin) in the treatment of hyperactive bladder syndrome and with respect...
Detailed Description
Patients will be randomized to receive the usual standard treatment with Solifenacin or treatment based on peripheral unilateral transcutaneous neuromodulation of the posterior tibial nerve .
Eligibility Criteria
Inclusion
- Women\> 18 years, diagnosed with hyperactive bladder syndrome for at least 6 months of evolution and who have taken Beta 3 agonists
Exclusion
- Patients who can contribute biased information: have previously consumed and abandoned anticholinergic drugs due to lack of efficacy or side effects; Suffering from hyperactive bladder of neurogenic origin (multiple sclerosis, Parkinson's, spinal cord injury); Present cystocele or any pelvic organ prolapse\> 2 according to Pelvic Organ Prolapse-Q classification
- Patients who may become worse with the interventions envisaged in the study: being a implantable automatic defibrillators; With cutaneous alterations in lower extremities that prevent the placement of electrodes on the surface; Women who are pregnant or who may be pregnant during the duration of the clinical trial (prior and at each evaluation visit urine Bhcg will be requested to rule out pregnancy) or patients who are not able to manage transcutaneous electrical neurostimulation on an outpatient basis ) Or patients in whom Solifenacin is contraindicated: urinary retention, severe gastrointestinal disorders (including toxic megacolon), myasthenia gravis, or narrow-angle glaucoma, and in patients at risk of these conditions as hypersensitive at first Active or to any of the excipients, undergoing hemodialysis, with moderate hepatic insufficiency or severe renal insufficiency or in simultaneous treatment with a potent inhibitor of CYP3A4, eg ketoconazole.
Key Trial Info
Start Date :
May 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2019
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03468465
Start Date
May 4 2018
End Date
March 1 2019
Last Update
August 2 2018
Active Locations (1)
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1
Hospital Clínico Universtario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120