drugset / Trial / NCT03468465
Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve for Solifenacin 10 mg. Hyperactive Bladder Syndrome
Phase 4
Unknown
110 enrolled
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
RandomizedParallel-groupOpen-labelOther
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.
Timeline
- Start
- 2018-05-04
- Primary completion
- 2019-03
- Completion
- 2019-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Solifenacin | Small molecule | 10 mg | — |