MedTrace Logo

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

NCT03468465 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-08-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Solifenacin Succinate

10 mg tablet daily during 75 days maximum

DEVICE

Neuro-Muscular Stimulators (NMS)

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

Sponsors & Collaborators

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    lead OTHER

Principal Investigators

  • José David Jiménez Parra, MD · Hospital Rafael Méndez (Lorca, Murcia. SPAIN)

  • María Luisa María Luisa, MD · Hospital Clínica Universitario Virgen de la Arrixaca (SPAIN)

  • José Felix Escudero Bregante, MD · Hospital Clínico Universitario Virgen de la Arrixaca (SPAIN)

  • Julián Oñate, MD · Hospital General Universitario Reina Sofía (SPAIN)

  • Ana Isabel López López, MD · Hospital Clínico Universitario San Juan (SPAIN)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468465 on ClinicalTrials.gov