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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000605-20 | EudraCT Number |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical device: Transcutaneous electrical neurostimulation | Experimental | Medical device 4 weeks with daily sessions of 30 minutes |
|
| Solifenacin | Active Comparator | 10 mg tablet daily during 75 days maximum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin Succinate | Drug | 10 mg tablet daily during 75 days maximum |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José David Jiménez Parra, MD | Hospital Rafael Méndez (Lorca, Murcia. SPAIN) | Principal Investigator |
| MarÃa Luisa MarÃa Luisa, MD | Hospital ClÃnica Universitario Virgen de la Arrixaca (SPAIN) | Principal Investigator |
| José Felix Escudero Bregante, MD | Hospital ClÃnico Universitario Virgen de la Arrixaca (SPAIN) | Principal Investigator |
| Julián Oñate, MD | Hospital General Universitario Reina SofÃa (SPAIN) | Principal Investigator |
| Ana Isabel López López, MD | Hospital ClÃnico Universitario San Juan (SPAIN) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universtario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
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| Neuro-Muscular Stimulators (NMS) | Device | 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 |
|
|
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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