Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve for Solifenacin 10 mg. Hyperactive Bladder Syndrome

Study Overview
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Brief Summary
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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 to the percentage of patients that improve 50% any of the 3 signs (Urinary frequency, diurnal / nocturnal frequency, urgency and urinary incontinence). To determine prognostic factors associated with insufficient improvement (less than 50% in the 3 main signs of hyperactive bladder syndrome (urinary frequency, urgency and urinary incontinence frequency) after treatment with T-PTNS and Solifenacin.

Detailed Description
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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 .

Official Title
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Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve (T-PTNS) for Solifenacin 10 mg. in the Treatment of Hyperactive Bladder Syndrome: no Inferiority Phase IV Randomized Clinical Trial

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Drug: Solifenacin Succinate
* Device: Neuro-Muscular Stimulators (NMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women> 18 years, diagnosed with hyperactive bladder syndrome for at least 6 months of evolution and who have taken Beta 3 agonists Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical device: Transcutaneous electrical neurostimulation<br>Medical device 4 weeks with daily sessions of 30 minutes | Device: Neuro-Muscular Stimulators (NMS)<br>* Treatment with T-PTNS will include a first induction period of 4 weeks with daily sessions of 30 minutes duration and performed at each subject's home (Monday through Friday, resting weekends) and a second recall period of 2 additional months, with a session every 4 weeks that will be held at the healthcare center. In total there will be 20 sessions in the induction period and 2 in the recall period<br>* Other names: T-PTNS;|
| Active Comparator: Solifenacin<br>10 mg tablet daily during 75 days maximum | Drug: Solifenacin Succinate<br>* 10 mg tablet daily during 75 days maximum<br>* Other names: Vesicare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate whether treatment with T-PTNS is not less than 3 months compared to the current standard pharmacological treatments regarding the episodes of urgency, urinary frequency, incontinence and nocturia, all measured with the 3-day voiding diary | 3- day voiding diary | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperactive Bladder Syndrome