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

Urinary Incontinence Clinical Trial

Official title: 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

Status Active, not recruiting

Clinical Trial 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 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.

Clinical Trial 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 . ;

Related Conditions & MeSH terms

• Enuresis
• Hyperkinesis
• Urinary Bladder, Overactive
• Urinary Incontinence

• NCT number: NCT03468465
• Study type: Interventional
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 4, 2018
• Completion date: March 2019