A Phase 4 interventional study of Solifenacin Succinate and Neuro-Muscular Stimulators (NMS) in Urinary Incontinence, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Status unknown at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-02.
Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Phase 4, Interventional, and Other
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 .
Exclusion Criteria:
Medical device 4 weeks with daily sessions of 30 minutes
Device: Neuro-Muscular Stimulators (NMS)
10 mg tablet daily during 75 days maximum
Drug: Solifenacin Succinate
10 mg tablet daily during 75 days maximum
Also known as: Vesicare
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
Also known as: T-PTNS
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
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia